Title: A Multicenter, Open-label, Phase 1b/2 Study To Evaluate Safety And Efficacy Of Avelumab (msb0010718c) In Combination With Chemotherapy With Or Without Other Anti-cancer Immunotherapies As First-line Treatment In Patients With Advanced Malignancies1
Principal Investigators: None listed.
Description: For this open-label, non-randomized phase 1b/2 trial (ClinicalTrials.gov Identifier: NCT03317496), researchers are evaluating whether avelumab, a PD-L1 inhibitor, is safe and effective in combination with chemotherapy for treating patients with non–small cell lung cancer (NSCLC) or urothelial cancer.
Patients with NSCLC (cohort A1) will receive pemetrexed, carboplatin, and avelumab; all participants will have advanced non-squamous disease. Patients with urothelial cancer (cohort A2) will receive gemcitabine, cisplatin, and avelumab.
The primary outcomes of the phase 1b part are the number of patients with dose-limiting toxicities and the confirmed objective response rate. Secondary outcomes include progression-free survival, duration of response, and overall survival.
The estimated enrollment is 80 patients.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03317496.
This study is sponsored by Pfizer.
- Clinicaltrials.gov. Safety and efficacy study of avelumab plus chemotherapy with or without other anti-cancer immunotherapy agents in patients with advanced malignancies. NCT03317496. https://clinicaltrials.gov/ct2/show/NCT03317496. Accessed January 26, 2018.