Trial results for the Phase 2 study investigating pembrolizumab in combination with cabozantinib for metastatic gastric and gastroesophageal adenocarcinoma were posted on ClinicalTrials.gov on 2025-08-11. The study enrolled 34 participants and reported a median overall survival of 5.5 months.
Background
The study investigated the combination of cabozantinib with pembrolizumab in subjects with advanced gastric and gastroesophageal adenocarcinoma. These participants had previously progressed on, or not tolerated, at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.
Trial design
The study (NCT04164979) was a Phase 2, single-arm, open-label clinical trial. It enrolled 34 participants with gastric adenocarcinoma and gastroesophageal cancer. The trial investigated the efficacy of cabozantinib in combination with pembrolizumab in subjects with advanced gastric and gastroesophageal adenocarcinoma who had progressed on, or not tolerated, at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.
Key results
Results for the combination of cabozantinib and pembrolizumab were reported for the enrolled 34 participants:
- The percentage of participants with progression-free survival at 6 months was 6 participants.
- The number of participants who experienced any Grade 3-5 adverse events was 3 participants.
- The overall response rate as assessed by RECIST v1.1 was observed in 1 participant.
- The median overall survival of patients who received cabozantinib and pembrolizumab was 5.5 months. The dispersion type was noted as a 95% Confidence Interval, though specific values were not provided.
What this means
The results from this Phase 2 single-arm study provide initial data on the efficacy and safety profile of cabozantinib combined with pembrolizumab in a difficult-to-treat population of patients with advanced gastric and gastroesophageal adenocarcinoma who have failed prior chemotherapy. The observed median overall survival of 5.5 months and an overall response rate in 1 participant offer insights into the potential activity of this combination in this setting. The occurrence of 3 participants experiencing Grade 3-5 adverse events indicates the safety considerations for this regimen.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04164979, titled "Ph II Study of Cabozantinib With Pembrolizumab in Metastatic Gastric and Gastroesophageal Adenocarcinoma," were posted on 2025-08-11 on clinicaltrials.gov.