Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04439214
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Lymphoma
  • Advanced Malignant Solid Neoplasm
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II MATCH treatment trial identifies the effects of nivolumab in patients whose cancer has a genetic change called mismatch repair deficiency. Mismatch repair deficiency refers to cells that have mutations (changes) in certain genes that are involved in correcting mistakes made when DNA is copied in a cell. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells with mismatch repair deficiency to grow and spread. Researchers hope to learn if nivolumab will shrink this type of cancer or stop its growth.

Key Dates

Start date
May 31, 2016
Status verified
Mar 2021
Primary completion
Oct 11, 2018
Completion
May 17, 2020

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab)
    Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression ]

Locations (1)

FacilityCityStateZIPSite coordinators
ECOG-ACRIN Cancer Research GroupPhiladelphiaPennsylvania19103-

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