Clinical Trial

Anticancer Treatment of Advanced Malignancies

Study Description

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Avelumab 800 mg in combination with pemetrexed / carboplatin

Avelumab Pemetrexed Carboplatin

Drug - Avelumab 800 mg in combination with gemcitabine / cisplatin.

Avelumab Gemcitabine Cisplatin

Drug - Avelumab 1200 mg in combination with pemetrexed/carboplatin

Avelumab Pemetrexed Carboplatin

Drug - Avelumab 1200 mg in combination with gemcitabine/cisplatin

Avelumab Gemcitabine Cisplatin

Additional Information

Official Study 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 MALIGNANCIES

Clinical Trial ID

NCT03317496

ParticipAid ID

Ddw1Ja