Active — Not RecruitingPhase 1/2

Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors

United States23 participantsStarted 2020-03-17

Plain-language summary

This phase I/II trial studies the side effects and best dose of avelumab with M6620 in treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). DDR deficiency refers to a decrease in the ability of cells to respond to damaged DNA and to repair the damage, which can be caused by genetic mutations. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab together with M6620 may help to control DDR deficient metastatic or unresectable solid tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Subjects must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective * Subjects will be eligible for this study based on the presence of actionable aberrations in one or more of the following DNA damage response (DDR) genes: ARID1A, ATM, ATR, ATRX, BAP1, BARD1, BRCA1/2, BRIP1, CDK12, CHEK2, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, MSH2, NBN (NBS1), PALB2, RAD51, RAD51C, RAD51D, SMARCB1, and VHL, or other related genes at the discretion of the principal investigator in consultation with the MD Anderson Cancer Center Institute for Personalized Cancer Therapy Precision Oncology Decision Support (PODS) group. Variant interpretation for actionability will be performed by PODS * Subjects with germline defects in DDR genes are eligible for this trial * The collection of archival tumor tissue (within 1 year prior to study enrollment) will be mandatory. Tumor biopsies on cycle 1 day 15 will be mandatory. Subjects will not be put at undue risk to obtain the biopsy at cycle 1 day 15 (C1D15). A biopsy at C1D15 will not be required if it poses a serious/severe complication risk greater than 2%. All other biopsy time points are not mandatory but will be strongly encouraged where feasible. These include at baseline and at disease progression. Archival and fresh tissue requests can be waived in exceptional circumstances with principal investigator (PI) approv…

What they're measuring

Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine the Recommended Phase 2 Dose (RP2D).

Timeframe: The DLT monitoring time frame was the first 28-days of study participation (Cycle 1).

Trial details

NCT IDNCT04266912

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-13

Results submitted2025-09-12