Trial results for a combination of Nivolumab and Cabozantinib S-malate in treating advanced, recurrent, or metastatic endometrial cancer were posted on ClinicalTrials.gov on 2026-04-29. The combination arm demonstrated a median progression-free survival of 5.3 months, significantly longer than the 1.9 months observed with nivolumab alone.
Background
Endometrial cancer that is advanced, recurrent, or metastatic presents significant treatment challenges. Nivolumab is an immunotherapy, a monoclonal antibody designed to help the body's immune system target cancer cells. Cabozantinib S-malate is an agent that may inhibit tumor cell growth by blocking enzymes essential for cell proliferation.
Trial design
This randomized Phase 2 trial (NCT03367741) enrolled 82 participants with advanced, recurrent, or metastatic endometrial cancer, including Stage III and Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8. The study investigated the efficacy of a combination of cabozantinib s-malate and nivolumab (Arm A) compared to nivolumab alone (Arm B).
Key results
Key efficacy and safety measurements were reported for the study arms:
- Progression-Free Survival (PFS): The median PFS was 5.3 months for Arm A (Cabozantinib S-malate, Nivolumab) and 1.9 months for Arm B (Nivolumab).
- Overall Response Rate (ORR): The ORR was 25 Percentage for Arm A (Cabozantinib S-malate, Nivolumab) and 11 Percentage for Arm B (Nivolumab).
- Overall Survival (OS): The median OS was 13 months for Arm A (Cabozantinib S-malate, Nivolumab) and 7.9 months for Arm B (Nivolumab).
- Incidence of Adverse Events: 11 participants in Arm A (Cabozantinib S-malate, Nivolumab) experienced adverse events, compared to 0 participants in Arm B (Nivolumab). An exploratory cohort (Arm C) reported 10 participants with adverse events.
What this means
The results suggest that the combination of Nivolumab and Cabozantinib S-malate may offer improved outcomes for patients with advanced, recurrent, or metastatic endometrial cancer compared to Nivolumab monotherapy. The observed increases in median PFS, ORR, and median OS in the combination arm indicate a potential clinical benefit. While the combination arm showed a higher incidence of adverse events compared to nivolumab monotherapy in this trial, further evaluation of the safety profile is warranted.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03367741, titled "Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer," were posted on 2026-04-29 on clinicaltrials.gov.