MS100070_0119 - JAVELIN Bladder Medley
Research type
Research Study
Full title
A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination with Other Anti-Tumor Agents as a Maintenance Treatment in Participants with Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress with First Line Platinum-Containing Chemotherapy
IRAS ID
1004983
Contact name
Gilbert Mueller
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2021-003669-36
Clinicaltrials.gov Identifier
Research summary
This is an open-label, parallel arm, randomised, multicentre study. In this study, avelumab is being evaluated alone and in combination with 3 other drugs called sacituzumab govitecan, M6223, and NKTR-255 for the treatment of patients with bladder cancer (urothelial cancer) who have not progressed after first-line therapy. The cancer has either grown outside the body part it started in but has not spread to other parts of the body (locally advanced) or that the cancer has spread to other parts of the body (metastatic).
The use of avelumab in combination with sacituzumab govitecan, M6223, and NKTR-255 has not yet been approved by any health authorities and is still being tested for safety and effectiveness.
The purpose of this research study is to find out how safe and well tolerated the study medication is and whether it works for patients with locally advanced or metastatic urothelial cancer.
Approx. 252 people between 18 or older will participate, conducted in about 100 medical centres globally.
The study consists of 4 groups (A, B, C and D). Study participants will be enrolled randomly in one of the groups, each group given a different treatment.
• Group A: Avelumab monotherapy (given on its own)
• Group B: Avelumab with Sacituzumab govitecan
• Group C: Avelumab with M6223
• Group D: Avelumab with NKTR-255
The study is divided into a screening period, treatment period, and follow-up period. Study participants will be assigned to one of the groups during the treatment period.
Study drug infusions are given until the disease worsens, experience of unacceptable side effects, the participant or the study doctor decide to stop treatment, or the study ends, whichever comes first. Participants may continue to receive study drug infusions after the disease worsens, if the study doctor feels that they will benefit from the drug.
Follow-up period will be 30 and 90 days safety follow-up after last dose. Long-term follow-up every 12 weeks via phone call.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0085
Date of REC Opinion
5 Jul 2022
REC opinion
Further Information Favourable Opinion