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
- Nivolumab — BIOLOGICALGiven IV
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania | 19103 | - |
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