Trial results for a Phase 2 study evaluating pemetrexed and pembrolizumab for recurrent and/or metastatic salivary gland cancer were posted on ClinicalTrials.gov on 2026-06-04. The study reported a confirmed response rate of 0.375 for patients with non-adenoid cystic carcinoma.
Background
This Phase 2 trial investigated the combination of pemetrexed and pembrolizumab for treating patients with recurrent and/or metastatic salivary gland cancer. The study included specific cohorts for adenoid cystic carcinoma and non-adenoid cystic carcinoma, as well as Stage IV Major Salivary Gland Cancer AJCC v8. The aim was to assess the effect of this combination therapy in stopping the growth and spread of tumor cells.
Trial design
The Phase 2 study (NCT04895735) enrolled 45 participants with recurrent and/or metastatic salivary gland cancer, including those with Stage IV Major Salivary Gland Cancer AJCC v8 and adenoid cystic carcinoma. The trial evaluated the effect of pemetrexed and pembrolizumab in this patient population, with participants divided into cohorts based on their specific cancer type.
Key results
The trial reported the following key measurements:
- For Confirmed Response Rate in Cohort A (Adenoid Cystic Carcinoma), the proportion of participants was 0.
- For Confirmed Response Rate in Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3), the proportion of participants was 0.11.
- For Confirmed Response Rate in Cohort B (Non-adenoid Cystic Carcinoma), the proportion of participants was 0.375.
- For Clinical Benefit Rate (CBR) in Cohort A, the proportion of patients was 0.727.
- For Clinical Benefit Rate (CBR) in Cohort A1, the proportion of patients was 1.0.
- For Clinical Benefit Rate (CBR) in Cohort B (Non-adenoid Cystic Carcinoma), the proportion of patients was 0.583.
- Regarding Incidence of Adverse Events, 8 participants were affected in Cohort A, 8 participants in Cohort A1, and 19 participants in Cohort B (Non-adenoid Cystic Carcinoma).
What this means
The results from this Phase 2 trial suggest varying responses to pemetrexed and pembrolizumab across different subtypes of recurrent and/or metastatic salivary gland cancer. Notably, patients with non-adenoid cystic carcinoma (Cohort B) showed a confirmed response rate of 0.375, along with a clinical benefit rate of 0.583. For adenoid cystic carcinoma (Cohort A), the confirmed response rate was 0, though the clinical benefit rate was 0.727. A subset of ACC patients (Cohort A1) showed a confirmed response rate of 0.11 and a clinical benefit rate of 1.0. These findings indicate that the combination therapy may offer clinical benefit, particularly in non-adenoid cystic carcinoma and specific adenoid cystic carcinoma subsets, warranting further investigation into these patient populations.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04895735, titled "MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer", were posted on 2026-06-04 on clinicaltrials.gov.