An open-label continuation study for avelumab study participants
Research type
Research Study
Full title
AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER SPONSORED AVELUMAB CLINICAL STUDIES
IRAS ID
306483
Contact name
Katherine Slyfield
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-002457-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
126,065, US IND Number
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
The purpose of this study (B9991046) is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for participants transitioning off previous Pfizer avelumab studies.
There are nine (9) Pfizer avelumab studies with ongoing participants currently coming to a close worldwide. The UK is currently running five (5) of these studies: B9991023, B9991025, B9991001, B9991003, B9991004. As these studies come to a close it is important that participants be provided continued access to study treatment where they are benefiting.
This study, B9991046, is an umbrella study set-up to bring all eligible Pfizer avelumab study participants onto a single trial, where they will continue to receive treatment matching their previous study. To make this possible, this study has one master protocol which covers several “sub” protocols. There is a sub-protocol for each of the five (5) avelumab studies ending in the UK that still have ongoing participants. The sub-protocols can be considered as being approximately equivalent to study arms.
The B9991046 master study is designed to reduce the study participation burden for patients to a minimum while still providing beneficial study treatment. As such, studies involve limited mandated study procedures, primarily standard of care tests and scans participants would receive as part of their non-study treatment. Each sub-study permits the continuation of previously received study treatment for each study participant, unique to their prior studies and established dosage requirements.
There will be about 300 participants taking part in the master study. The continuation study is taking place at approximately 156 research sites in 26 countries. This study is being funded and run by Pfizer.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0290
Date of REC Opinion
24 Jan 2022
REC opinion
Further Information Favourable Opinion