Trial results for a Phase 1/2 study (NCT03739619) investigating nivolumab in combination with gemcitabine and bendamustine for patients with relapsed or refractory classical Hodgkin lymphoma were posted on ClinicalTrials.gov on 2025-08-06. The study, which enrolled 3 participants, reported 1 complete response and an overall response rate of 1 participant.
Background
The trial investigated a combination therapy for classical Hodgkin lymphoma that had either returned (recurrent) or did not respond to previous treatments (refractory). This combination included nivolumab, an immunotherapy, alongside chemotherapy agents gemcitabine and bendamustine. Chemotherapy drugs like gemcitabine and bendamustine work to stop tumor cell growth, while immunotherapy with monoclonal antibodies such as nivolumab may assist the body's immune system in attacking cancer.
Trial design
The study (NCT03739619) was a Phase 1/2 trial with an overall status of COMPLETED. It enrolled 3 participants with recurrent Hodgkin lymphoma, refractory Hodgkin lymphoma, or classical Hodgkin lymphoma. The trial aimed to study the side effects and best dose of gemcitabine, bendamustine, and nivolumab when given together, and to assess how well they work in treating patients.
Key results
Key measurements from the Phase 2 portion of the trial included:
- For "Complete Response (CR) Rate": 1 participant in the Gemcitabine, Bendamustine, Nivolumab group achieved a complete response.
- For "Overall Response Rate": 1 participant in the Gemcitabine, Bendamustine, Nivolumab group achieved an overall response.
- For "Duration of Response": The mean duration of response was 892 Days (95% Confidence Interval) in the Gemcitabine, Bendamustine, Nivolumab group.
- The "Maximum Tolerable Dose (Phase I)" was reported as NA participants.
- "Progression Free Survival (PFS)" was reported as NA months (95% Confidence Interval).
- "Overall Survival (OS)" was reported as NA months (95% Confidence Interval).
What this means
The results from this small Phase 1/2 trial provide initial data on the combination of nivolumab, gemcitabine, and bendamustine in a challenging patient population with relapsed or refractory classical Hodgkin lymphoma. While a complete response was observed in 1 of 3 participants, the very limited enrollment means these findings are preliminary and do not allow for definitive conclusions regarding efficacy or safety profile. Further research would be needed to fully evaluate this combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03739619, titled "Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma," were posted on 2025-08-06 on clinicaltrials.gov.