Toxicity was predominantly low grade.Ī variety of refractory cancers (2.0% of those screened) had MMR deficiency as defined in NCI-MATCH. An additional 21% of patients had stable disease. The most common histologies were endometrioid endometrial adenocarcinoma (n = 13), prostate adenocarcinoma (n = 5), and uterine carcinosarcoma (n = 4).
Forty-two evaluable patients were enrolled, with a median age of 60 years and a median of 3 prior therapies.
Two percent of 4,902 screened patients had an MMR-deficient cancer by IHC. The primary end point was RECIST 1.1 objective response rate (ORR). Disease reassessment was performed every 2 cycles. Nivolumab, 3 mg/kg every 2 weeks (28-day cycles) and 480 mg every 4 weeks after cycle 4, was administered intravenously. Patients with MMR-deficient colorectal cancer were excluded. MMR deficiency was defined by complete loss of nuclear expression of MLH1 or MSH2 MMR gene products by immunohistochemistry (IHC). We hypothesized that nivolumab would have activity in patients with MMR-deficient, noncolorectal tumors.Įligible patients with relapsed or refractory tumors, good end-organ function, and Eastern Cooperative Oncology Group performance status of ≤ 1 underwent tumor biopsy for centralized screening of molecular alterations. The anti-programmed death receptor 1 inhibitor nivolumab previously showed activity in mismatch repair (MMR)-deficient colon cancer.
The National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH) trial, the largest national precision oncology study to date (> 1,100 sites) of patients with relapsed or refractory malignancies, assigned patients to targeted therapy in parallel phase II studies based on tumor molecular alterations.
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