Trial results for Nivolumab in combination with chemotherapy for soft tissue sarcoma were posted on ClinicalTrials.gov on 2026-05-05. The study, NCT04339738, investigated adding Nivolumab to paclitaxel in taxane-naive patients, showing a median progression-free survival of 5.6 months for the combination compared to 8.3 months for paclitaxel alone.
Background
Nivolumab is an immunotherapy that works through the body's immune system to help it act against tumor cells. Chemotherapy drugs like paclitaxel aim to stop the growth of tumor cells. This trial investigated its use in patients with soft tissue sarcoma, specifically focusing on Skin Angiosarcoma, Skin Radiation-Related Angiosarcoma, and Visceral Angiosarcoma.
Trial design
The study, NCT04339738, was a Phase 2 trial with an enrollment of 90 participants. It investigated the addition of Nivolumab to chemotherapy in patients with Soft Tissue Sarcoma, including Skin Angiosarcoma, Skin Radiation-Related Angiosarcoma, and Visceral Angiosarcoma. The trial included different arms: Arm I evaluated Nivolumab plus paclitaxel in taxane-naive patients, Arm II evaluated paclitaxel alone in taxane-naive patients, and Arm III evaluated Nivolumab plus cabozantinib s-malate in taxane-pretreated patients.
Key results
For the outcome of "Progression Free Survival (PFS) in Taxane Naive Patients With Angiosarcoma":
- In Arm I (Nivolumab, Paclitaxel), the median PFS was 5.6 months.
- In Arm II (Paclitaxel), the median PFS was 8.3 months.
An analysis using the Log Rank method for this outcome showed a Hazard Ratio (HR) of 1.23 (95.0% CI: 0.6 to 2.52) with a p-value of 0.5782.
For the outcome of "Overall Response Rate (ORR) in Angiosarcoma Patients Who Have Had Prior Taxane", in Arm III (Nivolumab, Cabozantinib S-malate), the count of participants was 13 Participants.
What this means
The results from the Phase 2 trial NCT04339738 indicate that the addition of Nivolumab to paclitaxel in taxane-naive patients with angiosarcoma did not improve progression-free survival compared to paclitaxel alone. The median PFS was numerically shorter in the combination arm, and the statistical analysis showed no significant difference. For taxane-pretreated patients, 13 participants showed an overall response with Nivolumab and cabozantinib s-malate, providing some insight into this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04339738, titled "Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma," were posted on 2026-05-05 on clinicaltrials.gov.