Clinical Trials

An up-to-date list of clinical trials currently enrolling patients with appendix cancer and/or pseudomyxoma peritonei from appendiceal origin is provided below.

The ACPMP Research Foundation attempts to keep this list as updated and complete as possible.  Please note, however, that the primary public sources from which this list is compiled do not always reflect the most recent changes to enrollment status, and there may be changes to the enrollment status or new trials added that are not yet reflected in the periodic updates provided.  Nevertheless, the below list of clinical trials, and the contact information provided for each, is intended to provide sufficient baseline information for use by any individual interested in further exploring potential eligibility and participation.

For more information on clinical trials for appendix cancer and/or pseudomyxoma peritonei or to update any of the information below, please contact Deborah Shelton.

CLINICAL TRIALS OVERVIEW

Clinical studies (often also commonly referred to as clinical trials or clinical research) can have many different objectives, depending on the specific study.  Such objectives may include, for example, developing new treatments, identifying causes of a disease or condition, studying trends, and evaluating ways in which genetics may be related to a disease or condition.

Typically, a new therapy or procedure is first tested in the laboratory and in animal studies, and, if the results merit further investigation, it is then moved into a clinical trial (ie., tested in humans).  The clinical trial testing is conducted in phases (generally Phase 1, 2, and 3, each of which is briefly explained below).  Depending on the particular phase, clinical trials are designed to obtain more detailed information about the investigational therapy, including its safety profile, risks, and effectiveness.

Sometimes a patient decides to participate in a clinical trial because none of the treatments otherwise available have worked, or they find them to have side effects that are not tolerable.  In this way, clinical trials can sometimes provide another option when standard therapies have failed.  Other patients participate in a clinical trial because they want to contribute to the advancement of medical knowledge.  Often, an individual that decides to participate in a clinical trial does so with both goals in mind.

The study of an investigational drug in humans proceeds in phases, with the information learned from each phase used to build upon the next: generally Phase 1, 2, and 3.

Clinical trials – particularly for new cancer therapies – are sometimes collapsed.  In other words, some researchers design these trials to combine to phases into a single study protocol (e.g., Phase 1/2, or Phase 2/3).  The reason for this type of design is to help facilitate a more seamless transition between phases, potentially allowing research questions to be answered more quickly or with fewer patients.

The National Cancer Institute (NCI) provides the following examples of benefits and risks of participating in a clinical trial that should be considered in deciding whether a clinical trial may be right for you:

Potential Benefits: may include having access to a new therapy that is not otherwise available; close monitoring by the clinical research team; being among the first to benefit from a therapy that is determined to be more effective than the standard treatment; and helping researchers learn more about your type of cancer; and benefitting the larger patient population in the future.

Potential Risks: may include the investigational treatment may be inferior to the standard treatment, or may not work for the individual patient at all; there may be unanticipated side effects or worse side effects than the standard treatment; increased doctors visits and associated expenses, including travel and logistical support; extra tests may be required that may be both time-consuming and uncomfortable; and a patient’s health insurance may not cover all patient costs in a clinical trial.

For additional information, see NIH's Clinical Trials Information for Patients and Caregivers.

A phase 1 study is early testing in humans.  Its purpose is to determine dosing, safety and tolerance of an investigational drug and to gather information about its biological activity within the body.

Once an acceptable margin of safety is established for the investigational drug, Phase 2 begins.  A Phase 2 study is generally the first study in which primary measurements will be made to determine efficacy of the investigational drug.  In terms of the a study’s objectives, though, the line between a Phase 1 and Phase 2 study can sometimes be somewhat blurred, particularly in the case of oncology trials where there is a small study population and interest in expediting development process while appropriately safeguarding patient safety.

A Phase 3 study is a large, pivotal safety and effectiveness trial.  Information gathered during this stage includes additional evidence of safety and efficacy, long-term tolerance, drug interactions, etc.

CURRENT CLINICAL TRIALS

The compilation of clinical-trial information provided is organized as follows: (1) the name of the clinical trial, and the study identifier and link to the clinicaltrials.gov registry providing more detailed information; (2) a brief summary of the protocol/objectives of the trial, (3) key baseline eligibility criteria, and (4) study contact information.  Please note that the eligibility criteria for any given clinical trial are typically extensive, and thus not detailed in the list of clinical trials provided here. All of the inclusion and exclusion criteria can be accessed, however, through the clinicaltrials.gov link provided for that particular trial and should be discussed further with your physician and/or the contact person listed for that clinical trial.  Examples of common eligibility for a clinical study of a new investigational cancer drug include (a) having a specific type or stage of cancer; (b) having received or not received a certain kind of prior therapy; (c) having specific genetic changes in your tumor; (d) medical history; and (e) current health status.

Each clinical trial is assigned a specific identifier; the identifier is referred to formally as the NCT number in the U.S. and is the registry number as provided in the listing for that trial at ClinicalTrials.gov.  The NCT number and the corresponding link to the full listing on ClinicalTrials.gov is provided for each clinical trial listed here where applicable.

The following is a list of current clinical trials but may be of interest to AC/PMP patients. This list is organized by (1) phase of trial, and then (2) within each phase, the type of trial (i.e., (A) Appendix Cancer-Specific; (B) Tumor Agnostic; and (C) Unspecified Solid Tumor). For your additional information, each of these types of trials is described briefly below:

Appendix Cancer-Specific:
These trials are focused, at least in part, directly on Appendix Cancer and PMP.

Tumor Agnostic:
Tumor-agnostic clinical trials focus on the study of what is sometimes referred to as tumor-agnostic treatments. Tumor-agnostic treatments are drugs that are used to treat any type of cancer, regardless of the organ or type of tissue from which the cancer originally developed. Instead of the primary site of tumor origin, a tumor-agnostic treatment focuses on the tumor’s genetic make-up, including specific mutations or biomarkers. In other words, this type of therapy can be used when a person’s tumor has a very specific molecular alteration that is targeted by the drug or predicts that the drug is likely to work.

Unspecified Solid Tumor:
Although some of the trials listed below are so-called tumor-agnostic trials, some of the trials listed below involve solid tumors generally rather than appendix cancer specifically or tumors with specific mutations. We call these trials “other non-specific tumor” clinical trials.

The first group of tumor-agnostic (and other non-specific tumor) trials listed below are Phase 2 trials. The second group of tumor-agnostic listed beneath those are Phase 1/2 trials.

PHASE 1 CLINICAL TRIALS

A. Appendix Cancer-Specific

Intraperitoneal Oxaliplatin in Combo with IV mFOLFRI for Peritoneal Carcinomatosis from Colorectal & Appendiceal Cancer (IPOX-FOLFRI) (NCT04158349)

Location:  Huntsman Cancer Institute, Salt Lake City, Utah.

Brief description: This is a Phase 1 study to determine the maximum tolerated dose (MTD) of intraperitoneal oxaliplatin when given in combination with mFOLFRI, a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan.  This study will be halted once the maximum tolerated dose has been established.  During therapy, patients will be monitored for dose-limiting toxicities and adverse events.  Upon completion or cessation of participation, patients will be followed until resolution of any ongoing study treatment-related adverse events, initiation of alternative treatment, and survival.  Approximately 18 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • Confirmed appendiceal adenocarcinoma (or colon, rectal) with peritoneal dissemination of disease within 6 months or more after initial diagnosis.
  • Have Stage IV peritoneal-based disease only; must not have any metastases outside the peritoneal cavity.
  • Willing and able to to undergo placement of an intraperitoneal catheter (if do not already have one).
  • Willing to return for follow-up.

Contact:  Susan Sharry at 801-585-3453 (phone) or susan.sharry@hci.utah.edu (e-mail)

PHASE 2 CLINICAL TRIALS

A. Appendix Cancer-Specific

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors (NCT03693846)

Location: University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania.

Brief description: This is a Phase 2 clinical trial of patients with mucinous adenocarcinoma of the appendix (or colon, rectum).  A total of 21 patients will be enrolled.  Treatment will consist of nivolumab  (brand name OPDIVO) every 4 weeks and ipilimumab (brand name YERVOY) every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy.

Baseline Eligibility Criteria, include, but are not limited to:

  • metastatic disease confined to the peritoneum only;
  • prior systemic chemotherapy with FOLFOX and FOLFIRI unless contraindicated or refused;
  • immunohistochemistry testing demonstrates microsatellite stable and/or mismatch repair proficient;
  • no bowel obstruction within the past 60 days.

Contact Person(s): Nurse Navigator Trish Gambino; Study Nurse Lisa DiCicco.

Note: Dr. Thomas Karasic, one of the investigators for this trial, spoke about the trial at the Drexel ACPMP Patient-Practitioner Symposium: “Innovations in the Multidisciplinary Management of PMP/Appendiceal Cancer,” Saturday April 6, 2019, 7:30 am to 12:30 pm, Philadelphia, Pennsylvania.  The ACPMP Research Foundation was the co-host and sponsor of this educational event.

B. Tumor Agnostic

The MATCH Screening Trial: Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (NCT02465060)

Location(s):  National Cancer Institute, Bethesda, Maryland, and over a thousand other participating institutions throughout the U.S.

Brief description:  This is a large Phase 2 precision medicine trial to study the treatment directed by genetic testing in patients with solid tumors, including appendix, that have progressed following at least one line of standard treatment or for which there is no agreed upon treatment approach.  Approximately, a total of 6,452 participants will be enrolled across the numerous arms.  The thinking underlying this study is that patients with certain tumor mutations and other genetic abnormalities may benefit more from treatment that targets that tumor’s particular genetic abnormality.  Identifying those genetic abnormalities may help doctors plan better subsequent treatment for those patients.

In terms of steps to enroll, here is how it works.  First, the physician at one of the participating clinical trial sites orders genomic sequencing from one of the designated commercial labs.  Second, the lab tests the tumor sample for gene abnormalities for one or more being studied as part of the trial.  Third, if the patient does have an abnormality that matches one of the numerous ones being studied, the lab contacts the ordering physician and provides him or her with a written referral to the trial.  Fourth, if the patient and his or her physician decide to pursue the MATCH trial as a treatment option, the physician uses that written referral from the lab to register the patient for a screening assessment.  Fifth, the study personnel review the referral and formally assign the patient to the treatment arm for that genetic abnormality and notify the patient.  And Sixth, once the patient is enrolled in the treatment arm, the patient is treated as long as the tumor is shrinking or remains stable.

Baseline Eligibility Criteria, include, but are not limited to:

  • have medically (histologically) documented solid tumor (disease agnostic; this study is directed at certain genetic mutations) requiring therapy and meet either 1. or 2. below:
    • 1.  have progressed following at least one line of standard systemic therapy and there is no other approval/standard therapy available that has been shown to prolong overall survival.  Patients who cannot receive other standard therapy due to medical issues are eligible so long as the other eligibility criteria are met.  Note:  If the patient is currently receiving therapy, regardless of whether it is considered standard, the clinician must have assessed that the current therapy is no longer benefitting the patient.; or
    • 2.  have disease for which no standard treatment exists that has been shown to prolong survival; and
  • have measurable disease;
  • have received results from one of the designated laboratories indicating a “rare variant” of tumor that has been identified by participating commercial lab mutation of interest for this trial;
  • be able to swallow tablets or capsules; a patient with any GI disease that would impair ability to swallow, retain, or absorb drug is not eligible.

Contact Person(s):  Contact information is site-specific; review the site locations list to identify listed contact for the site(s) of interest to you.  If interested in participating at the NCI site, Bethesda, Maryland, please contact Deborah Shelton for specific contact information.

My Pathway:  A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants with Advanced Solid Tumors  (NCT02091141)

Location(s):  51 locations throughout the U.S.  For specific participating sites, contact Deborah Shelton.

Brief description:  This is a Phase 2 study in patients with metastatic cancer, including of appendiceal origin.  A total of approximately 765 participants will be enrolled.  Treatment will depend on specific treatment arm, which, in turn depends on that participant’s specific tumor mutation or gene expression abnormality as demonstrated by the molecular-testing results from a CLIA-certified laboratory (using tissue and/or blood, depending on treatment arm).  Specific mutations being tested specified below under “Baseline Eligibility Criteria.”

Baseline Eligibility Criteria, include, but are not limited to:

  • metastatic cancer (including of appendiceal origin);
  • Have received standard first-line therapy for metastatic cancer (except for a tumor type for which no first-line therapy exists) and for whom a trial of targeted therapy is considered the best available treatment option.  (NOTE:  To be eligible, should not have any available therapies that will convey clinical benefit and/or are not suitable options per the treating physician’s judgment);
  • no prior treatment with the specific assigned study drug or any other drug sharing that same molecular target;
  • Mutations being studied as part of trial:  EGFR-activating; BRAF V600; hedgehog pathway relevant mutation; ALK; and/or elevated tissue tumor mutational burden.  (Note:  HER2 is being studied only in biliary cancer, salivary cancer, and bladder cancer.)
  • for all treatment arms (except the one for elevated tissue tumor mutational burden, must have the ability to swallow pills (i.e., drug is atezolizumab (brand name TECENTRIQ)) and not have refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of the oral investigational drug.

Contact Person(s):  Pam Mangat

AZD1775 In Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification (NCT03253679)

Location:  Multiple locations in U.S.  See Locations tab for this clinical trial to identify location(s) of interest.

Brief description: This is a Phase 2 study of an investigational drug (AZD1775) in patients with metastatic tumors with CCNE1 amplification.  Approximately 32 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • Histologically advanced solid tumor harboring CCNE1 amplification.
  • Disease unresponsive to, or does not have, standard of care therapy; or patient has declined standard of care therapy

Contact:  Contact information specific to participating site.  For contact information, go to NCT link provided above, see list of Locations and click into one or more site(s) of interest.

Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations (NCT03212274)

Location:  Multiple locations in U.S. See Locations tab for this clinical trial to identify location(s) of interest.

Brief description: This is a Phase 2 study of the drug olaparib (brand name LYNPARZA) in treating patients with certain cancers, including those with solid tumors with IDH1 or IDH2 mutations that are metastatic.  Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.  Approximately 145 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • a solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation
  • tumors easily accessible for biopsy and willing to have serial biopsies in case of multiple lesions; tumor biopsies will be performed on the most accessible site of disease
  • able to swallow orally administered medication and not have GI disorders likely to interfere with the absorption of the study medication

Contact:

Contact specific to participating site.  For contact information, go to NCT link provided above, click on “Show 32 Study Locations” and identify one or more site(s) of interest.

Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6 (NCT03310879)

Location:  Dana Farber Cancer Institute, Boston, Massachusetts

Brief description: This is a Phase 2 study of an investigational drug, Abemaciclib (a CDK inhibitor),  as a possible treatment for cancer abnormality in one of the following genes:  CCND1, CCND2, CCND3, CDK4, or CDK6.  Approximately 38 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • Histologically or cytologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective
  • Depending on treatment arm, either: (1) a confirmed CCND1, 2, or 3 high-level amplification, CCND1 mutation, or a CCND1 splice variant expected to lead to nuclear retention of cyclin D1 protein; or (2) a confirmed CDK4 or CDK6 high-level amplification
  • Ability to swallow and retain oral medication
  • Must not have received prior treatment with a CDK4/6 inhibitor

Contact:

Geoffrey Shapiro, MD, PhD at 617-632-4942 (telephone) or geoffrey_shapiro@dfci.harvard.edu (e-mail); or Andrew Wolanski, Nurse Practitioner, at 617-632-6623 (telephone) or andrew_wolanski@dfci.harvard.edu

Adavosertib in Treating Patients With SETD2-Deficient Locally Advanced or Metastatic Solid Tumors (NCT03284385)

Location:  Multiple locations in U.S. See Locations tab for this clinical trial to identify location(s) of interest.

Brief description: This is a Phase 2 study of an investigational drug, adavosertib (a WEE1 inhibitor), in treating patients with metastatic SETD2-deficient solid tumors.  Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.  Approximately 60 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • confirmed locally advanced or metastatic solid tumor with progression on at least one prior systemic therapy and presence of biallelic loss of SETD2 detected in tumor tissue
  • able to swallow oral medications; no PEG tube or TPN
  • no prior treatment with a WEE1 inhibitor

Contact: Contact information specific to study site.  Identify study site of interest and click into contact information for that site.

Efficacy and Safety of Olaparib (MK-7339) in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002)/LYNK-002) (NCT03742895)

Locations:  Multiple locations in U.S. and in other countries.  See Locations tab for this clinical trial to identify location(s) of interest.

Brief description: This is a Phase 2 study of an investigational drug, olaparib (MK-7339), in participants with multiple types of advanced cancer (unresectable or metastatic) that:  (1) have progressed or are intolerant to standard of care therapy; and (2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).  Approximately 370 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • Histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor that is not eligible for curative treatment and for which standard of care therapy has failed.
  • Participants have progressed on, or be intolerable to, any standard of care therapies that are known to provide clinical benefit.  There is no limit on the number of prior treatment regimens.
  • Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
  • For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatin either as a single drug or in combination with other drugs) for advanced solid tumor, have no evidence of disease progression during the platinum chemotherapy.

Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors (NCT04056910)

Locations:  UPMC Hillman Cancer Center, Pittsburgh, PA

Brief description: This is a Phase 2 study of the safety and effectiveness of an investigational drug, ivosidenib, in combination with nivolumab (brand name OPDIVO) in participants with nonresectable or metastatic tumors.   Approximately 35 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • Histologically confirmed (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of an advanced solid tumor for which curative treatment is not available and have undergone appropriate standard of care treatment options (in the opinion of the treating investigator)
  • Have a documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on CLIA-certified sequencing
  • Must not have received a prior IDH inhibitor or prior checkpoint therapy (anti-PD1/L1 or anti-CTLA4 antibody)

NOTE:  As of May 20, 2020, the last update posted on clinicaltrials.gov was on April 24, 2020.  As of then, this trial shows as not yet recruiting.”  ACPMP Research Foundation recommends, however, that anyone interested in potentially participating in this trial reach out to the contacts listed below to receive any updates. Deborah Shelton has also done this and will seek to update with any additional information received.

Contact:  Krystie Eaton, BSN – 412-623-7957 (tel.) or mientkiewiczk@upmc.edu (e-mail); or Carrie Muniz, BSN – 412-623-6121 (tel.) or munizca@upmc.edu (e-mail)

Atezolizumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor (NCT03977467)

Locations:  Multiple locations in Florida, as well as two locations in Tennessee, and one location in Missouri.  Go to Locations tab at NCT link provided above to review specific sites participating.

Brief description: This is a Phase 2, two-part trial (A and B) of atezolizumab for patients with non-small cell lung cancer (NSCLC) (arm A of trial) or an advanced solid tumor that has been previously treated with a PD-1 inhibitor (either nivolumab (brand name OPDIVO ) or pembrolizumab (brand name KEYTRUDA) (arm B of trial).  Approximately 258 participants will be enrolled.

Baseline Eligibility Criteria for Arm B (advanced solid tumor) include, but are not limited to:

  • Patients with Microsatellite Instability high (MSI-high) tumor.  [Note:  additional tumor types may be added.]
  • Previously received and tolerated nivolumab (brand name OPDIVO) or pembrolizumab (brand name KEYTRUDA) therapy (and was the last therapy prior to enrollment in this clinical trial)
  • Evidence of disease progression

Contact:  Sarah Cannon Development Innovations – 844-710-6157 (tel.) or CANN.InnovationsMedical@sarahcannon.com (e-mail)

Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors (NCT03836352)

Locations:  U.S. locations in Florida, Louisiana, New York, and Texas; also multiple locations in Canada (in Ontario and Quebec).  Go to Locations tab at NCT link provided above to review specific sites participating.

Brief description: This is a Phase 2 with safety lead-in study to assess the safety and efficacy of an investigational drug, DPX-Survivac, low-dose cyclophosphamide, and pembrolizumab (brand name KEYTRUDA) combination therapy in participants with selected advanced and recurrent solid tumors, including microsatellite instability high (MSI-H) solid tumors.

Baseline Eligibility Criteria for Arm B (advanced solid tumor) include, but are not limited to:

  • Patients with Microsatellite Instability high (MSI-high)  tumors who have completed treatment with first-line therapy
  • Radiologic and/or biochemical evidence of disease progression
  • Completion of pre-treatment tumor biopsy
  • Participants (including MSI-H) other than those with gastric or colorectal cancer must have evidence of surviving expression in their pre-treatment biopsy sample
  • Must not have had prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor resulting in discontinuation from the treatment due to a Grade 3 or higher immune-related toxicity
  • Must not have clinical ascites or pleural fluid that cannot be managed
  • Must not have malignant bowel obstruction or recent history of bowel obstruction
  • Must not have a GI condition that might limit absorption of oral agents

Contact:  Contact persons are specific to clinical site location, and are listed under the locations tab for each site at the NCT hyperlink provided above.

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People with Advanced Stage Cancer (TAPUR) (NCT02693535)

Locations:  Multiple sites in U.S.  Go to Locations tab at NCT link provided above to review specific sites participating.

Brief description: This is a Phase 2 clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for the treatment of patients with advanced cancer that have a potentially actionable genomic variant.  This study will analyze FDA-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists, and develop  hypotheses for additional clinical trials.  This study will include approximately 3,123 participants.

Baseline Eligibility Criteria include, but are not limited to:

  • Histologically-proven locally advanced or metastatic solid tumor that is no longer benefiting from standard treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated
  • Have a tumor genomic profile for which single agent treatment with one of the FDA-approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in the protocol.  [Note:  There are 19 different arms (i.e., groups or cohorts of participants) in this trial, each for a different set of tumor markers/mutations and drug/combination of drugs.  To identify all these arms, go to the clinical trial link provided above (NCT02693535) and scroll down to “Arms and Interventions.”]
  • Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a CLIA-certified and College of American Pathologists-accredited or New York State accredited (for labs offering services to residents of NY) laboratory that has registered the test with the NIH Genetic Test Registry or has established an integration with the TAPUR study platform.  The genomic or IHC test used to qualify a patient for participation in this trial may have been performed on any specimen of the patient’s tumor obtained at any point during the patient’s care at the discretion of the patient’s treating physician.  Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
  • Must not have a GI condition that might limit absorption of oral agents

Contact:  Pam Mangat at pam.mangat@asco.org

Pembrolizumab Before Surgery for the Treatment of Mismatch Repair Deficient Locally Advanced Solid Cancers (NCT04082572)

Location:  M.D. Anderson Cancer Center, Houston, Texas

Brief description: This is Phase 2 study of how well pembrolizumab (brand name KEYTRUDA) works before surgery in treating patients with mismatch repair deficient cancers that have spread to nearby tissue or lymph nodes (locally advanced).  Approximately 35 participants will be enrolled.

Baseline Eligibility Criteria, include, but are not limited to:

  • Solid cancer that is deficient in mismatch repair (dMMR) or microsatellite instability high (MSI-H);
  • Locally advanced cancer defined as either an unresectable primary cancer or a resectable primary cancer with a high chance of recurrence (defined as an estimated greater or equal to 20% chance by the treating physician).  A resectable primary may include locoregional disease, as long as all disease is felt by the treating physician to be in a resectable distributuion;
  • Have available archival tumor tissue.  Availability will be met as long as a request to obtain tissue blocks (preferred) or slides has been made;
  • Must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)

Contact Person: Dr. Michael J. Overman at 713-792-2828

Pembrolizumab in Treating Patients with Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability (NCT03428802)

Location:  Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

Brief description: This is Phase 2 study of how well pembrolizumab (brand name KEYTRUDA) works in treating participants with cancer that has spread to other place in the body, has come back or has spread to nearby tissues or lymph nodes.  Approximately 40 participants will be enrolled.

Baseline Eligibility Criteria, include, but are not limited to:

  • Diagnosis of a tumor with evidence of genomic instability on Clinical Laboratory Improvement Amendments (CLIA)-certified genomic testing, inclusive of mutations in POLE, POLD1 for arm 1 and in BRCA1 and BRCA2 for arm 2.
  • Advanced cancer (metastatic, recurrent or locally advanced)
  • Willing to provide archived tumor tissue; tissue from the most obtained core or excisional biopsy preferred; 20 unstained slides are referred but a minimum of 15 slides is acceptable; if adequate tissue is not present the patient may consent to a newly obtained biopsy
  • Tumors harboring non-hotspot POLE or POLD1 mutations that show clear evidence of microstatellite instability (MSI) will be excluded

Contact Person: Janice M. Mehnert at 732-235-8945 (tel.) or  mehnerja@cinj.rutgers.edu  (e-mail)

Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers (NCT03868423)

Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

Brief description: This is a Phase 2 study of how well brigatinib (brand name ALUNBRIG) works in treating patients with ALK and ROS 1 gene alterations and cancers that have spread to nearby tissue and lymph nodes or other places in the body.

Baseline Eligibility Criteria, include, but are not limited to:

  • locally advanced or metastatic tumors
  • activating genomic alterations in ALK or ROS1 (mutations, fusions or amplifications) by any validated CLIA-certified molecular testing; CLIA-validated results from other institutions and commercial diagnostic labs (for example, Foundation Medicine) are also acceptable
  • patients with any progressive disease on any previous therapy, including ALK tyrosine kinase inhibitors (TKIs), chemotherapy or immunotherapy are eligible, and patients with locally advanced or metastatic tumors who have received no prior therapy of any kind (i.e., first-line therapy) are also eligible
  • tumor suitable for biopsy; however, if patients do not have a tumor suitable for biopsy but have another tissue (preferably progressive metastatic site) available for molecular evaluation, that is also acceptable

Contact Person:  The Ohio State University Comprehensive Cancer Center at 1-800-293-5066, or Dr. Sameek Roychowdhury at 614-685-5841 (tel.) or sameek.roychowdhury@osumc.edu (e-mail)

C. Unspecified Solid Tumor

A Study of the Drug 131I-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum (NCT04022213)

Locations:  Memorial Sloan Kettering Cancer Center, NY, New York.

Brief description: This is a Phase 2 study to determine whether treatment with the investigational drug 131I-Omburtamab can prevent or delay the worsening of Desmoplastic Small Round Cell Tumors/DSRCT or other cancers of the peritoneum.  This trial will enroll approximately 55 participants.

Baseline Eligibility Criteria for participants with a tumor type other than DSRCT (i.e., “Group C”) include, but are not limited to:

  • Have the diagnosis of tumors other than DSRCT, confirmed at Memorial Sloan Kettering
  • Have a tumor that involves the peritoneum
  • Omburtamab reactivity must be confirmed by immunohistochemistry except for tumors with a reported incidence of B7H3 expression of greater than 70%
  • Have a history of tumor progression or recurrence or failure to achieve complete remission after standard therapy
  • Less than 20% chance of long-term disease-free survival
  • Must not have clinically suspected dense intraperitoneal adhesions preventing adequate intraperitoneal distribution

Contact:  Dr. Shakeel Modak at 212-639-7623 (tel.) or modaks@mskcc.org, or Dr. Emily Slotkin at 212-639-8856 (tel.) or slotkine@mskcc.org (email).

Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors (DURVA+ Study) (NCT03907475)

Location: National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland..

Brief description: This is a Phase 2 study of the side effects of durvalumab (brand name IMFINZI) when given together with chemotherapy in treating patients with advanced tumors.  Giving chemotherapy with durvalumab may improve how immune cells respond and attack tumor cells.  The primary outcome measure of this trial is the incidence of adverse events.  Other outcome measures include changes in the microenvironment, immunotherapy response of tumor-infiltrating and circulating T-cells, and the immune status of the tumor and overall tumor mutational load.  Approximately 115 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • metastatic or locally advanced (not amenable to surgery) tumors that have progressed following at least one line of standard therapy and/or no standard of treatment exists that has been shown to prolong survival
  • must have tumor amenable to biopsy and be willing to undergo a tumor biopsy
  • if have had prior treatment with a checkpoint inhibitor, must not have been taken off drug for serious adverse events.  Patients who had prior CTLA-4 inhibitor treatment and did not experience serious adverse events are eligible for all arms.  Patients who had prior PD-L1/PD-1 inhibitor treatment and did not experience serious adverse events are excluded from the durvalumab monotherapy arm but are eligible for the chemotherapy combinations.

Contact Person:  NCI Site Public Contact at 1-800-411-1222

Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors (NCT02938793)

Location:  Greenville Health System Cancer Institute, Greenville, South Carolina

Brief description: This is an investigator-initiated Phase 2 study of durvalumab (brand name IMFINIZI) in combination with the investigational drug, tremelimumab, in individuals with select advanced rare solid tumors. Approximately 50 patients will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • diagnosis of a rare advanced solid malignancy meeting EORTC criteria
  • willingness to undergo biopsy of a tumor site or have recent (less than 2 years) archival material available
  • must not have previously received durvalumab or tremelimumab or any checkpoint inhibitor

Contacts: Julie C. Martin, DNP, 864-455-3600 extension 3667 (telephone) or julie.martin@prismahealth.org (e-mail); or Jan Kueber, RN, BSN, 864-455-3600 extension 3774 (telephone) or jan.keuber@prismahealth.org (e-mail)

PHASE 1/2 CLINICAL TRIALS

A. Appendix Cancer-Specific

Phase 1/2 Study to Investigate the Safety, Biologic, and Antitumor Activity of ONCOS-102 in combination with Durvalumab (brand name IMFINZI) in Patients with Peritoneal Malignancies (NCT02963831)

Location(s): Ludwig Cancer Institute - Research Facilities in Miami, Florida; Buffalo, New York; Toledo, Ohio, and Charlottesville, Virginia.

Brief description: This is a Phase 1/2 study in patients with peritoneal disease, including from appendiceal carcinoma.  A total of approximately 78 participants will be enrolled.  Treatment will consist of ONCOS-102 (an investigational drug) administered intraperitoneally once a week for a total of 6 weeks, and durvalumb (brand name IMFINZI) administered by IV infusion once every four weeks for a total of 12 four-week cycles.

Baseline Eligibility Criteria, include, but are not limited to:

  • peritoneal malignancy, including cancer originating from the appendix;
  • failed on prior standard chemotherapy with no additional therapy options available known to prolong survival;
  • willing to undergo a core needle biopsy during screening and during Study Week 5;
  • no ongoing bowel perforation or presence of bowel fistula or abscess, or history of small or large bowel obstruction within 3 months of registering for the clinical trial, including persons with palliative gastric drainage catheters;  NOTE: palliative diverting ileostomy or colostomy ARE ALLOWED if patient has been symptom-free for more than 3 months.

Contact Person(s)Lisa Shohara and/or Danielle McCabe, Tel. 212-450-1515

Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies (NCT03834272)

Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts.

Brief description: This is a Phase 1/2 study of patients with metastases of the peritoneum from primary gastrointestinal cancer or appendiceal cancer, ovarian cancer, or mesothelioma. A total of 18 patients will be enrolled. This study is being conducted to test if the investigational drug (LUM015) can be given to patients at a dose that allows tumor tissue to be identified by the LUM Imaging System during surgery. Treatment will include intraoperative injection of an investigational drug (LUM015) and in vivo imaging with a handheld optical head.

Baseline Eligibility Criteria, include, but are not limited to:

  • metastases to the peritoneum from appendiceal cancer, gastrointestinal cancer, ovarian cancer, or mesothelioma;
  • must be scheduled for surgical resection (cytoreduction);
  • no investigational drugs within 30 days prior to surgery;
  • no history of allergic reaction to any oral or intravenous contrast agents.

Contact Person(s): Principal Investigator James Cusack, MD or Study Coordinator Bridget Kelly  – Tel.617-724-4093

Injection of Bromelain and Acetylcysteine in combination into recurrent mucinous tumor or pseudomyxoma peritonei: a phase 1/2 study (Australian New Zealand Clinical Trials Registry (ANZCTR) Universal Trial Number (UTN) U1111-1203-1657)

Location(s): St. George Hospital – Kogarah, Australia

Brief description: This is a Phase 1/2 study in patients with mucinous peritoneal tumor, including PMP that are not suitable for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) or other potentially beneficial surgery.   A total of approximately 60 participants will be enrolled.  The combination of Bromelain and Acetylcysteine will be injected directly into the tumor or peritoneal cavity via a drain and allowed to dwell for 24 hours with the expectation that the tumor will be dissolved by the drug combination administered.  The tumor will then be drained and a repeat treatment will be considered.  The dose of the drug is dependent on the calculated tumor dimensions and volume.

Baseline Eligibility Criteria, include, but are not limited to:

  • patients with psuedomyxoma Peritonei (PMP or mucinous soft to intermediate grade tumor who are not candidates for CRS/HIPEC or other surgery;
    • Note:  Having hard tumor in one region does not exclude treatment in another area provided the appearance is mucinous.
  • in the case of a target lesion (versus free intraperitoneal), the tumor must be safely accessible percutaneously;
  • no suspected fistula of the tumor into the GI tract, invading or abutting major vessel or other area of concern;
  • no infected tumor (pus on aspiration or indicated on blood test).

Contact Person(s)Sarah Valle, Tel. +61291132070

Note: Currently enrolling in Australia only; U.S. and European are forthcoming.

B. Tumor-Agnostic

APL-101 Study of Subjects with NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA) (NCT03175224)

Location:  Multiple locations in U.S.

Brief description: This is a Phase 1/2 study of an investigational drug (APL-101, a c-MET inhibitor) in patients with c-MET dysregulation advanced solid tumors.  Approximately 145 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • histologically and/or cytological confirmed locally advanced, recurrent or relapsed or metastatic incurable solid malignancy
  • tumor with c-Met high amplification or c-Met fusions
  • local/archival result (tissue and/or plasma) of a positive c-Met dysregulation
  • must not have known mutation/gene rearrangement of EGFR, ALK, ROS1, RET, NTRK, KRAS, BRAF or other driver mutation/gene rearrangement apart from MET
  • impairment of GI function or GI disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)

Contact:

Lynn Manlapaz-Espiritu 650-209-4055 (phone) or Lenilyn.Espiritu@apollomicsinc.com (email), or Gavin Choy, 650-209-4055 (phone) or gavin.choy@apollomicsinc.com (e-mail)

A Study of Repotrectinib (TPX-0005) in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTK1-3 Rearrangements (TRIDENT-1) (NCT03093116)

Location:  Multiple locations in U.S., as well as Australia, Singapore and Korea

Brief description: This is a Phase 1/2 study of an investigational drug, repotrectinib (TPX-0005), in patients with locally advanced or metastatic solid tumor that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol-specified tests. Approximately 450 participants will be enrolled.

Baseline Eligibility Criteria for patients with a RET fusion or mutation include, but are not limited to:

  • cocumented ROS1, ALK or NTRK1-3 gene fusion that has been identified by local testing and that has been prospectively confirmed by a central diagnostic laboratory selected by the clinical trial Sponsor to determine molecular eligibility prior to enrollment
  • capability to swallow capsules intact (without chewing, crushing, or opening)
  • must not have gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption

Contact:

Dr. Shanna Stopatschinskaja 858-276-0000 clinical@tptherapeutics.com

Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW)  (NCT03037385)

Location:  Multiple locations in U.S. and other countries

Brief description: This is a Phase 1/2 study of an investigational drug, pralsetinib (BLU-667) administered orally in certain patients, including those with RET-altered solid tumors. The study consists of two parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2).  Both parts will enroll patients with certain patients, including those with advanced solid tumors with a RET alteration (fusion or mutation).

Baseline Eligibility Criteria for patients with a RET fusion or mutation include, but are not limited to:

  • pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion or mutation that was previously treated with a selective TKI (one cohort) that inhibits RET or with standard of care appropriate for the tumor type and not eligible for any of the other groups (another cohort).
  • must have non-resectable disease
  • patient’s cancer must not have a known primary driver alteration other than RET (e.g., oncogenic KRAS, NRAS, or BRAF mutation)
  • must not have previously received durvalumab or tremelimumab or any checkpoint inhibitor

Contact:

Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com

A Study of Zenocutuzumab (MCLA-128) in Patients with Solid Tumors Harboring an NGR1 Fusion (NCT02912949)

Location:  Multiple locations in U.S. and outside of U.S.

Brief description: This is a Phase 1/2 clinical trial; Part 1 was a dose escalation and is reported as having been completed.  Part 2 is a dose expansion cohort.  Part 2 will include new patient populations, including patients with any solid tumor with documented NRG1 fusion.  Participants in the Part 2 solid tumor (basket) harboring NRG1 fusion will receive IV infusion of the investigational drug zenocutuzumab (MCLA-12* at the recommended Phase 2 dose every two weeks.  The study will consist of 3 periods:  screening period (up to 28 days prior to the first dose of study drug); treatment period (treatment cycles of 28 days); and follow-up period (through 30 days after the last dose and quarterly checks for survival data for up to 2 years).

Baseline Eligibility Criteria include, but are not limited to:

  • locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion
  • able to provide a tumor biopsy sample (fresh strongly preferred or else archival)
  • have received prior standard therapy appropriate for tumor type and stage of disease, or, in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy

Contact: Dr. Deborah Morosini, MD at d.morosini@merus.nl

M7824 in Patients with Metastatic Colorectal Cancer or With Advanced Solid Tumors With Advanced Solid Tumors With Microsatellite Instability (NCT03436563)

Location: M.D. Anderson Cancer Center, Houston, Texas

Brief description: This is a Phase 1b/2 clinical trial to study how well an investigational anti-PD-L1/TGFbetaRII fusion protein (M7824) works in treating patients with colorectal cancer or with other solid tumors with microsatellite instability that has spread to other places in the body or cannot be removed by surgery.  Approximately 74 participants will be enrolled.

Baseline Eligibility Criteria for participants with microsatellite instability in a non-colorectal tumor, include, but are not limited to:

  • confirmed microsatellite instability
  • disease progression following prior immune checkpoint blockade therapy
  • intolerance or serious adverse immune-related adverse events that were symptomatic or required or continues to require ongoing immunosuppression to previous immune checkpoint therapy
  • known severe hypersensitivity reactions to monoclonal antibodies (greater than grade 3), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma

Contact Person(s): Van K. Morris at 713-792-2828 (tel.) or vkmorris@mdanderson.org (e-mail)

Study of RP1 Monotherapy and RP1 in Combination with Nivolumab (NCT03767348)

Location: Participating sites throughout U.S. and the UK.   For specific sites, go to link above for this clinical trial and scroll down to “Contacts and Locations” list.

Brief description: This is a Phase 1/2 clinical study of an investigational drug (RP1) alone and in combination with nivolumab (brand name OPDIVO) in participants with advanced and/or refractory tumors to determine the maximum tolerated dose and recommended Phase 2 dose, as well as to evaluate preliminary efficacy.  The study will include a dose escalation phase for the investigational drug, a dose-expansion phase with a combination of RP1 and nivolumab, and a Phase 2 portion in specified tumor types for the combination therapy.  RP1 is described as a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor response.  Approximately 281 participants will be enrolled.

Baseline Eligibility Criteria for the cohort for which AC/PMP patients may be eligible, include, but are not limited to:

  • diagnosis of a tumor that is microsatellite stability high (MSI-H) or (dMMR) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available

Contact Person: Gail Iodice at 857-701-2235 (tel.) or RPL-001-16@replimune.com (e-mail).  Additional contacts also listed for each participating site.  To obtain that contact information, click on the clinical trials link above for this trial and scroll down to the “Contacts and Locations” information.

A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors (NCT03637491)

Location: Participating sites throughout U.S., as well as in Belgium and Singapore.  For specific sites, go to link above for this clinical trial and scroll down to “Contacts and Locations” list.

Brief description: This is a Phase 1b/2 clinical study of the safety, clinical activity, and pharmacokinetic (PK), and pharmacodynamics (PD) of combinations of avelumab (brand name BAVENCIO) binimetinib (brand name MEKTONI) and talazoparib (brand name TALZENNA) in patients with metastatic pancreatic ductal adenocarcinoma and other locally advanced or metastatic KRAS- or NRAS-mutant tumors.  The phase 1b part of this study will initially assess two-drug (i.e., sometimes referred to as “doublet”) combinations to determine a recommended dose for further investigation.  Following this, the recommended dose for the combination of avelumab, binimetinib and talazoparib (i.e., 3-drug combination or “triplet”) will be determined.  The recommended doses for the doublet and triplet combinations will be used in the Phase 2 part of the study, which will assess the safety and preliminary anti-tumor activity of the study treatments.  Approximately 122 participants will be enrolled.

Baseline Eligibility Criteria for the cohort for which AC/PMP patients may be eligible, include, but are not limited to:

  • locally advanced (primary or recurrent) or metastatic tumors with documented positive KRAS or NRAS mutation and not amenable for treatment with curative intent
  • have had disease progression during or following at least 1 and not more than 2 prior lines of treatment for advanced or metastatic disease
  • provision of a baseline tumor sample
  • no known history of immune-mediated colitis or inflammatory bowel disease
  • no prior treatment  with avelumab, a PARP inhibitor or MEK inhibitor

Contact Person:  Pfizer CT.gov Call Center at 1-800-718-1021 (tel.) or ClinicalTrials.gov_Inquiries@pfizer.com (e-mail).  Additional contacts also listed for each participating site.  To obtain that contact information, click on the clinical trials link above for this trial and scroll down to the “Contacts and Locations” information.

Dose-Escalation and Dose-Expansion of RMC-4630 and Cobimetinib in Relapsed/Refractory Solid Tumors (NCT03989115)

Location: Participating sites throughout U.S., as well as in Belgium and Singapore.  For specific sites, go to link above for this clinical trial and scroll down to “Contacts and Locations” list.

Brief description: This is a Phase 1b/2 clinical study of the safety, clinical activity, and pharmacokinetic (PK), and pharmacodynamics (PD) of combinations of avelumab (brand name BAVENCIO) binimetinib (brand name MEKTONI) and talazoparib (brand name TALZENNA) in patients with metastatic pancreatic ductal adenocarcinoma and other locally advanced or metastatic KRAS- or NRAS-mutant tumors.  The phase 1b part of this study will initially assess two-drug combinations (i.e., “doublet”) to determine a recommended dose for further investigation.  Following this, the recommended dose for the combination of avelumab, binimetinib and talazoparib (i.e., 3-drug combination or “triplet”) will be determined.  The recommended doses for the doublet and triplet combinations will be used in the Phase 2 part of the study, which will assess the safety and preliminary anti-tumor activity of the study treatments.  Approximately 122 participants will be enrolled.

Baseline Eligibility Criteria for the cohort for which AC/PMP patients may be eligible, include, but are not limited to:

  • locally advanced (primary or recurrent) or metastatic tumors with documented positive KRAS or NRAS mutation and not amenable for treatment with curative intent
  • have had disease progression during or following at least 1 and not more than 2 prior lines of treatment for advanced or metastatic disease
  • provision of a baseline tumor sample
  • no known history of immune-mediated colitis or inflammatory bowel disease
  • no prior treatment  with avelumab, a PARP inhibitor or MEK inhibitor

Contact Person:  Pfizer CT.gov Call Center at 1-800-718-1021 (tel.) or ClinicalTrials.gov_Inquiries@pfizer.com (e-mail).  Additional contacts also listed for each participating site.  To obtain that contact information, click on the clinical trials link above for this trial and scroll down to the “Contacts and Locations” information.

Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Cancer (NCT03919292)

Location: Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia.

Brief description: This is a Phase 1/2 clinical study to determine the recommended phase 2 dose of neratinib (brand name NERLYNX) and sodium valproate when given in combination to patients with advanced solid tumors in 28-day cycles.  The Phase 2 portion of the study will evaluate the combination at the recommended dose in 3 cohorts of RAS-mutated tumors:  KRAS mutant colorectal cancer, KRAS mutant pancreatic cancer, and K or N RAS mutant solid tumors.    Approximately 81 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • advanced K or N-RAS mutant tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
  • able to swallow oral medication
  • no prior therapy with neratinib
  • no uncontrolled diarrhea leading to dehydration or electrolyte disturbances not easily controlled with oral repletion
  • no known or suspected malabsorption condition or obstruction

Contact Person:  Dr. Andrew Poklepovic at 804-628-2321 (tel.) or Andrew.poklepovic@vcuhealth.org (e-mail); Massey SIIT Team at 804-628-9238 (tel.) or masseysiit@vcu.edu (e-mail); Kristen Bodine, RN at 804-628-5273 (tel.) or klbodine@vcu.edu (e-mail)

C. Unspecified Solid Tumor

PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients with Solid Tumors or DLBCL (NCT03543813)

Location: Multiple locations in U.S.  To view locations, click on above clinical trial link and and go to “Contacts and Locations” section.

Brief description: This is a Phase 1/2 clinical trial (dose escalation, followed by dose expansion) to study the safety and efficacy of an investigational drug (CX-2029) in participants with metastatic or locally advanced unresectable tumors.  Approximately 150 participants will be enrolled.

Baseline Eligibility Criteria, include, but are not limited to:

  • confirmed diagnosis of metastatic or locally advanced unresectable tumors
  • demonstrated disease progression after treatment with approved therapies that are known to confirm life-prolonging benefit, or who are intolerant to or have declined treatment
  • agree to provide mandatory archival tissue or fresh biopsy
  • no history of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy
  • no transfusion dependent anemia with transfusion dependency of 3 months or longer
  • no use of iron chelators

Contact Person(s): Lori Carman at 650-515-4267 (tel.) or clinicaltrials@cytomx.com (e-mail)

A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination with Nivolumab or Ipilimumab in Patients with Advanced Solid Tumors (NCT03251924)

Location:  Multiple locations in U.S., as well as participating sites in Canada, Spain, and Switzerland.

Brief description: This is a Phase 1/2 study of an investigational drug (BMS-986226) to evaluate its safety and tolerability, pharmacokinetics, and efficacy alone or in combination with nivolumab (brand name OPDIVO) or ipilimumab (brand name YERVOY) in patients with advanced solid tumors.  Approximately 234 participants will be enrolled.

Baseline Eligibility Criteria include, but are not limited to:

  • histological or cytological confirmation of a malignancy that is metastatic and/or unresectable with measurable disease
  • at least one lesion accessible for biopsy in addition to the target lesion
  • have received, and then progressed or been intolerant to, at least 1 standard treatment regimen
  • must not have had prior adverse reaction to tetanus toxoid-containing vaccines

Contact: Contact specific to participating site.  For contact information, go to NCT link provided above, see list of Locations and click into one or more site(s) of interest.

A Study of the Effects of ALKS 4230 on Subjects With Solid Tumors (NCT02799095)

Location: Multiple sites in U.S. and Canada show as recruiting.  Sites include locations in Tampa, Florida; Boston, Massachusetts; Detroit, Michigan; Buffalo, NY; NY, NY; Cleveland, Ohio; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada.

Brief description: This is a Phase 1/2 clinical trial of an Alkermes investigational drug administered alone and in combination with Pembrolizumab (brand name KEYTRUDA) in subjects with advanced solid tumors.  A total of 300 individuals will be enrolled.   One of the arms of this trial (“Part C”) (the investigational drug in combination with Pembrolizumab) is accepting patients with unspecified advanced solid tumors.

Baseline Eligibility Criteria for Part C, include, but are not limited to:

  • advanced solid tumors that have returned after treatment with established approved therapies or that the individual is intolerant of established therapies;
  • acceptable lab testing results;
  • recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery

Contact Person(s): Melanie Owen at 513-763-1937 (phone) or melanie.owen@syneoshealt.com (e-mail)

An Investigational Immunotherapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab (NCT02754141)

Location: Multiple sites show as recruiting.  Click on “Show 26 Study Locations” link at above URL to review locations and points of contact.

Brief description: This is a Phase 1/2a clinical trial of patients with advanced solid tumors.  A total of 268 patients will be enrolled across all participating sites.  Treatment will consist of administration of a Bristol-Myers Squibb (BMS) investigational drug (BMS-986179) alone and in combination with Nivolumab (BMS-936558).

Baseline Eligibility Criteria, include, but are not limited to:

  • solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective);
  • acceptable lab testing results;
  • permission for biopsies

Contact Person(s): Click on “Show 26 Study Locations” link at above URL to review locations and points of contact.

An Investigational Immunotherapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Patients With Solid Cancers That Are Advanced or Have Spread (NCT02737475)

Location: Two sites show as currently recruiting:  John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey; and Roswell Park Cancer Institute, Buffalo, New York

Brief description: This is a Phase 1/2 clinical trial of patients with advanced solid tumors.   Treatment will consist of administration of a Bristol-Myers Squibb (BMS) investigational drug (BMS-986178) in Part 1 of the trial (i.e., dose escalation phase).  In Part 2 of the trial (i.e., dose escalation and expansion), treatment will consistent of the BMS investigational drug in combination with Nivolumab (brand name OPDIVO) and/or Ipilimumab (brand name YERVOY) at specified doses at specified intervals.  This trial also includes a dose schedule and exploration arm that consists of the BMS investigational drug with tetanus vaccine at specified doses and interval.  Approximately 435 patients will be enrolled.

Baseline Eligibility Criteria, include, but are not limited to:

  • at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting;
  • at least one measurable lesion at baseline by CT or MRI;
  • a fresh tumor biopsy

Contact Person(s): Martin Gutierrez (for John Theurer Cancer Center at Hackensack University Medical Center) (see link above for contact information); Igor Puzanov (716-845-4101) (for Roswell Park Cancer Institute).

9-ING-41 in Patients With Advanced Cancers (NCT03678883)

Location: Participating sites in California, Florida, Georgia, Minnesota, Rhode Island, and South Dakota.  For specific sites, go to link above for this clinical trial and scroll down to “Contacts and Locations” list.

Brief description: This is a Phase 1/2 clinical study of an investigational drug (9-ING-41).  This study has 3 parts:  Part 1 is a dose escalation study for  9-ING-41 alone; Part 2 is a dose escalation study for 9-ING-41 as part of 7 different chemotherapy combination regimens; and Part 3 is an assessment of activity of activity of 9-ING-41-based combination regimens.  The primary objective for Part 3 is to assess the clinical benefit of each of the seven 9-ING-41-based combination regimens.

Baseline Eligibility Criteria include, but are not limited to:

  • advanced or metastatic malignancy characterized by one or more of the following:
    • patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
    • malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
    • malignancy has relapsed after standard therapy
    • malignancy for which there is no standard therapy that improves survival by at least 3 months
  • for Parts 2 and 3 (described above), must have received prior therapy for the same malignancy including the same potential partner chemotherapeutic agent(s) as that/those being considered for administration on study in combination with 9-ING-41.  Agent depends on combination regiment to which a participant is assigned but may include gemcitabine, doxorubicin, lomustine, carboplatin, irinotecan, nab-paclitaxel plus gemcitabine, paclitaxel plus carboplatin)
  • provision of a baseline tumor sample

Contact Person:  Dr. Francis J. Giles at 281-796-1852 (tel.) or fgiles@actuatetherapeutics.com (e-mail).  Additional contacts also listed for each participating site.  To obtain that contact information, click on the clinical trials link above for this trial and scroll down to the “Contacts and Locations” information.

Dose Escalation and Expansion Study of GSK3359609 in Subjects with Selected Advanced Solid Tumors (INDUCE-1) (NCT02723955)

Locations:  Multiple throughout U.S. and outside of U.S.  U.S. sites in CA, FLA, NY, OK, PA, TN.  Participating sites outside of U.S. in Australia; Canada; France; Netherlands; and Spain.  For specific participating sites, contact Deborah Shelton.

Brief description:  This is a Phase 1 clinical trial of patients with advanced or recurrent solid tumors, including appendiceal.  A total of approximately 500 patients will be enrolled.  Treatment will consist of an investigational drug administered as a stand-alone therapy and in combination with pembrolizumab (brand name KEYTRUDA)  or specified chemotherapy regimens.

Baseline Eligibility Criteria, include, but are not limited to:

  • invasive appendiceal malignancy (or others as specified) that has been  diagnosed as locally advanced/metastatic or relapsed/refractory;
  • disease has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or no further standard therapy exists;
  • recent history (within 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction
  • recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.

Contact Person(s):  US GSK Clinical Trials Call Center at 877-379-3718, or for specific site locations/contact information anywhere within or outside of U.S., please contact Deborah Shelton.

Mesothlin-Targeted Immunotoxin LMB-100 in Combination with Tofacitinib in Persons with Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors (NCT04034238)

Location:  National Cancer Institute (Bethesda, Maryland)

Brief description:  This is a Phase 1 study of patients with solid tumors that express the protein mesothelin.  The primary objective of the study is to determine a tolerable and safe dose of the investigational drug, LMB-100, in combination with an FDA-approved drug (approved for other uses such as arthritis and ulcerative colitis) called tofacitinib (brand name Xeljanz).  This study will enroll approximately 45 participants.

Baseline Eligibility Criteria, include, but are not limited to:

  • Any solid tumor for which at least 20% of tumor cells express mesothelin. [Note:  With patient consent, NCI can screen any appendiceal patients to determine whether their tumor is mesothelin-positive and, thus, eligible to enroll in this clinical trial.];
  • No curative therapy exists for the patient;
  • Must have received at least one prior standard chemotherapy regimen for advanced disease OR be ineligible to receive available standard therapy, or have received all available standard therapies available for prior treatment of early stage disease;
  • If disease is deficient MisMatch Repair (dMMR) or Micro-Satellite Instability High (MSI-H), must have received at least one prior anti-PD1 therapy, OR be ineligible due to other medical conditions, or have refused anti-PD1 therapy.

Contact Person(s)Maureen E. Edgerly, R.N. - Tel. 240-760-6013

Note: NCI reached out to ACPMP for assistance and to build awareness for this trial. Click here for blog post. 

PHASE 3 CLINICAL TRIALS

None currently identified.  

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