Publication Date:
2019-11-13
Description:
Background: Nivolumab, a human anti-PD1 antibody has the potential to increase rituximab-mediated effector mechanism, to target the microenviroment and PD-1 in aggressive Non-Hodgkin lymphoma. Addition of nivolumab might increase efficacy conventional chemotherapy, which is always combined with rituximab in case of B-cell lymphoma. Therefore, a safety run-in was conducted to determine the tolerability of the combination prior to proceeding with a larger randomized phase 3 study aimed to compare of (R)-GemOx vs. Nivolumab plus (R)-GemOx. Methods: This is an ongoing international, multicenter, randomized, open label study. Key eligibility criteria include: first relapse or progression of an aggressive lymphoma (B-cell as well as peripheral T-cell lymphoma (PTCL)), ineligibility for HDT (defined as 〉65 years of age or older than 18 years if HCT-CI score 〉 2), only one prior chemotherapy regimen including an anthracycline and rituximab (R) in case of B-cell lymphoma. A non-randomized safety run-in phase was performed in 16 pts to assess potential toxicities of Nivolumab in combination with (R)-GemOx. Pts were planned to receive 8 bi-weekly cycles of Gemcitabine 1000 mg/m2, Oxaliplatin 100 mg/m2, R 375 mg/m2 all given on day 1. Nivolumab 3 mg/kg was given every two weeks for a total of 26 applications or until progression. Importantly, first application of Nivolumab was prior to first application of R. Response was evaluated after 4 and 8 cycles of (R)-Gemox. Safety analysis was performed after the last patient had gone through interim restaging after 4 cycles of (R)-GemOx. Progression/relapse of PTCL was scored as severe adverse event (SAE). Results: Sixteen pts were enrolled in the safety run-in, 10 pts with B cell lymphoma, all DLBCLs and 6 with PTCL. Recruitment was from 12-Jan-2018 until 17-May-2018, snapshot of database on 09-Aug-2018. Median age was 76 years, 9 (56%) pts were male, 8 (50%) had time-to-treatment failure
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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