Substudy 04A: Phase 1/2 Umbrella Study in Urothelial Carcinoma
Research type
Research Study
Full title
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants with PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A
IRAS ID
1006217
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2020-004544-28
Clinicaltrials.gov Identifier
Research summary
Despite recent advances in treatment options, locally advanced or metastatic urothelial carcinoma (UC) is a serious and incurable condition with poor long-term survival and a high unmet medical need.
This trial is testing experimental treatments with or without pembrolizumab (pembro) in people with refractory locally advanced or metastatic UC (a type of bladder cancer that has not responded to treatments and has spread to other parts of the body).
Pembro (also called KEYTRUDA®) has been approved to treat many types of cancers but has not been approved to treat this exact type of UC.
About 40 male and female participants, aged 18 years or older will take part in each treatment group of this trial.
There is a screening phase to see if participants can join the trial, lasting about one month.
The length of treatment will depend on the experimental treatment the participant is assigned. In some cases, participants will continue to receive treatment as long as their cancer does not get worse and they can tolerate the drugs.
Participants assigned to pembro treatment will receive it every 3 weeks or every 6 weeks for approximately 2 years.
During the trial, participants will undergo procedures such as physical examinations, ECGs, blood/urine samples and scans.
The Sponsor estimates that the trial will require approximately 5 years per treatment arm from the time the first participant agrees to take part until the last trial related contact.
The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD).
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0676
Date of REC Opinion
25 Oct 2022
REC opinion
Further Information Favourable Opinion