Trial results for the Phase 1/2 study (NCT04611126) investigating T-cell therapy in combination with Nivolumab, Relatlimab, and Ipilimumab for patients with metastatic ovarian cancer were posted on ClinicalTrials.gov on 2025-08-12. The trial was terminated early, with 5 of the 6 enrolled participants experiencing Grade III or worse adverse events in the arm without Ipilimumab.
Background
Nivolumab is an immunotherapy drug. The trial aimed to explore the potential of T-cell therapy, specifically adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs), in combination with immune checkpoint inhibitors for patients with advanced ovarian cancer, metastatic fallopian tube cancer, and peritoneal cancer. Previous pilot trials combining ACT with the CTLA-4 inhibitor Ipilimumab and the PD-1 inhibitor Nivolumab observed only transient clinical responses in advanced ovarian cancer patients.
Trial design
The Phase 1/2 study (NCT04611126) was designed to evaluate T-cell therapy in combination with Nivolumab, Relatlimab, and Ipilimumab for patients with metastatic ovarian cancer, metastatic fallopian tube cancer, and peritoneal cancer. The trial enrolled a total of 6 participants and was ultimately terminated. Interventions included ipilimumab, cyclophosphamid, fludarabine phosphate, tumor infiltrating lymphocytes infusion, and nivolumab. The study design involved groups both with Ipilimumab and without Ipilimumab in the combination therapy.
Key results
The trial results highlighted several outcomes related to safety, feasibility, and response among the 6 enrolled participants:
- For the outcome "Number of Participants Experiencing Grade III or Worse Adverse Events," 5 participants in the group without Ipilimumab experienced such events, while 0 participants in the group with Ipilimumab did.
- Regarding "Number of Patients Excluded Due to Feasibility Issues," 1 participant was excluded in the group without Ipilimumab, and 0 in the group with Ipilimumab.
- For "Best Overall Response (BOR)," 3 participants in the group without Ipilimumab showed a response, compared to 0 participants in the group with Ipilimumab.
- No patients were excluded due to treatment-related safety issues in either group.
What this means
The early termination of this Phase 1/2 trial, combined with the observed safety and feasibility issues, indicates significant challenges in the combination of T-cell therapy with Nivolumab and other agents for metastatic ovarian cancer. The finding that 5 of the 6 participants experienced Grade III or worse adverse events in the arm without Ipilimumab suggests a substantial safety concern within this specific regimen. While some best overall responses were observed in the group without Ipilimumab, the overall termination and safety profile underscore the complexities of developing effective and tolerable immunotherapies for this challenging cancer type.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04611126, titled "T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer," were posted on 2025-08-12 on clinicaltrials.gov.