Phase 1B/2 Study of Avelumab combined with Standard Care Chemotherapy
Research type
Research Study
Full 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
IRAS ID
237051
Contact name
Duncan Wheatley
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2017-001741-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
134730, US IND
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
Non-Squamous Non Small Cell Lung Cancer (NSCLC) is a disease in which malignant cells form in the tissues of the lungs and it accounts for 25-30% of lung cancers.\n\nUrothelial Cancer (UC) includes tumours that began from cells lining the bladder and urinary tract. Bladder cancer alone accounts for 90% of UC, and is the ninth most common type of cancer worldwide.\n\nThe main purpose of this research study is to investigate avelumab in combination with chemotherapy with or without other anti-cancer immunotherapies, as first-line treatment in adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with standard-of-care\nchemotherapy in patients with advanced non-squamous NSCLC and cisplatin-eligible urothelial cancer (UC).These two tumor types were selected for the study because they are responsive to chemotherapy,which currently is first-line standard-of-care for these indications. In addition, avelumab has shown preliminary evidence of clinical activity in both non-squamous NSCLC and UC. \nAddition of new therapy combinations will be based on emerging data regarding the safety and clinical benefit of each agent to be combined with avelumab and will be accomplished by protocol amendment. Only 1 additional anti-cancer immunotherapy, in combination with avelumab and chemotherapy, in up to 4 tumor-specific cohorts, will be included. \nGroup A:avelumab plus chemotherapy alone:\nCohort A1: avelumab plus pemetrexed/carboplatin in patients with non-squamous\nNSCLC;\nCohort A2: avelumab plus gemcitabine/cisplatin in patients with cisplatin-eligible\nUC.\n\nThis study is open-label, so both the participants and the study doctors will know the treatment assignment.\nThe duration of participation in this study will depend on the participant’s ability to safely tolerate the treatment, on how the participant’s cancer responds to treatment, and on the participant’s/study doctor’s decision to continue study\ntreatment.\nThis study is being sponsored by Pfizer. Approximately 80 participants will take part in the study, with approximately 10 participants in the UK.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0049
Date of REC Opinion
3 Apr 2018
REC opinion
Further Information Favourable Opinion