Study on Avelumab and M6620 for Treating Advanced Solid Tumors with DNA Repair Issues

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04266912

Provider View

This clinical trial is testing a combination of two drugs, avelumab and M6620, to see if they are safe and effective in treating advanced solid tumors that have spread or cannot be removed by surgery. These tumors have a problem with repairing damaged DNA, which can make them harder to treat.

Patient Parameters

Program Overview

This study is exploring the use of two drugs, avelumab and M6620, to treat advanced solid tumors that have spread to other parts of the body or cannot be surgically removed. These tumors have a deficiency in DNA damage repair, meaning they struggle to fix damaged DNA, often due to genetic mutations. Avelumab is an immunotherapy drug that may help the immune system attack cancer cells, while M6620 may stop tumor growth by blocking certain enzymes needed for cell growth. The study aims to find the best dose and assess the safety and effectiveness of this drug combination.

Description

The main goals of this study are to determine how safe and tolerable the combination of M6620 and avelumab is for patients with advanced solid tumors that have DNA repair issues. Researchers will also find the best dose to use in future studies.

Secondary goals include evaluating how well the treatment works by measuring the rate of complete or partial responses and stable disease lasting more than six months. The study will also look at overall survival, how long responses last, and how long patients live without the disease getting worse.

Exploratory goals involve understanding how specific DNA repair issues affect treatment benefits, how the treatment impacts certain immune markers, and identifying potential resistance mechanisms by comparing biopsies before and during treatment. The study will also assess how the drugs are processed in the body.

Participants will receive avelumab through an IV on days 1 and 15, and M6620 on days 1, 8, 15, and 22, in 28-day cycles, as long as the disease does not progress and side effects are manageable. After treatment, follow-ups will occur at 30, 60, and 90 days, then every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer that has spread or cannot be removed by surgery, with no effective standard treatments available.
  • Have specific genetic changes in DNA repair genes, such as BRCA1/2, ATM, or others, as determined by the study team.
  • Provide a tumor tissue sample from within the last year and agree to a biopsy during the study, unless it poses a high risk.
  • Have received at least one prior treatment for advanced cancer, or have no known effective options.
  • Have measurable disease according to standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception and avoid fathering a child during and after the study.
  • Provide informed consent and be willing to comply with study procedures.
  • HIV-positive patients may participate if they meet specific criteria regarding viral load and CD4 count.

Exclusion Criteria

  • Have received cancer treatment or radiation within 4 weeks before starting the study drugs.
  • Have active brain metastases requiring steroids.
  • Use immunosuppressive medication, except for certain low-dose steroids.
  • Have had major surgery within 4 weeks before starting the study.
  • Have severe allergies to the study drugs or their components.
  • Have active infections requiring treatment.
  • Have a history of certain autoimmune diseases or organ transplants.
  • Have significant heart disease or other serious medical conditions.
  • Be pregnant or breastfeeding, or unwilling to use effective contraception.
  • Have active hepatitis B or C infections.
  • Have another active cancer requiring treatment.
  • Have unresolved side effects from previous treatments.
  • Be taking certain medications that cannot be stopped before the study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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