Trial results for nivolumab in a Phase 2 study (NCT04205409) for relapsed, refractory, or detectable hematologic malignancies post CAR T-cell treatment were posted on ClinicalTrials.gov on 2025-11-03. The study reported an overall response rate in 2 out of 20 participants, with 0 participants achieving progression-free survival.
Background
The Phase 2 trial investigated nivolumab for the treatment of hematologic malignancies that have relapsed, are refractory, or remain detectable following prior CAR T-cell therapy. Nivolumab is an immunotherapy, a type of monoclonal antibody designed to help the body's immune system target and attack cancer cells, potentially interfering with tumor growth and spread.
Trial design
The study (NCT04205409) was a Phase 2 trial that enrolled 20 participants. It focused on individuals with recurrent chronic lymphocytic leukemia, recurrent diffuse large B-cell lymphoma, and recurrent follicular lymphoma, including Grade 1 and Grade 2 follicular lymphoma. All participants had relapsed, refractory, or detectable disease after previous chimeric antigen receptor T-cell (CAR T-cell) treatment.
Key results
The trial results provided data on several outcomes for participants receiving nivolumab. For the "Best Overall Response Rate (ORR)", 2 participants achieved a response. Regarding "Overall Survival", 8 participants were reported. For "Progression-free Survival", 0 participants were reported. The "Incidence of Adverse Events" was observed in all 20 participants.
What this means
The posted results from this Phase 2 trial suggest a limited overall response rate for nivolumab in patients with relapsed, refractory, or detectable hematologic malignancies following CAR T-cell therapy. With an ORR in 2 out of 20 participants and no reported progression-free survival, these initial findings indicate that further research may be needed to understand the potential role of nivolumab in this specific, heavily pre-treated patient population. The observation of adverse events in all 20 participants also highlights the importance of continued safety monitoring.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04205409, titled "Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies," were posted on 2025-11-03 on clinicaltrials.gov.