NCTa unique identification code assigned to each clinical study registered on ClinicalTrials.gov 04241185
Brief Summary
Researchers are looking for new ways to treat muscle-invasive bladdera hollow, muscular sac in the pelvis that stores urine cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body.
MIBC is treated by having surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence to remove the bladder (cystectomycomplete or partial removal of the bladder). Not all people choose to have surgery and want to keep their bladder using other treatments.
Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells (a treatment with medicine to destroy cancer cellsthe basic structural and functional unit of all living things or stop them growing) and Radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells (a treatment that uses beams of intense energy [like X-rays] to shrink or get rid of tumors).
Pembrolizumab is an immunotherapya treatment that uses a person's immune system to fight cancer, which is a treatment that helps the immune system fight cancer.
A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand if the study medicine works.
The goal of this study is to learn:
1. If a study medicine pembrolizumab given with Chemoradiotherapy (CRT) can help people live longer without their cancer growing, spreading, or coming back compared to placebo given with CRT.
2.About the safety and how well people tolerate CRT alone or in combination with pembrolizumab.
Intervention / Treatment
- Drug: Pembrolizumab
- Radiation: Conventional Radiotherapy (Bladder only)
- Radiation: Conventional Radiotherapy (Bladder and pelvic nodes)
- Radiation: Hypofractionated Radiotherapy (Bladder only)
- Drug: Cisplatin
- Drug: Fluorouracil (5-FU)
- Drug: Mitomycin C (MMC)
- Drug: Gemcitabine
- Drug: Placebo to Pembrolizumab
Inclusion Criteria:
- Has a histologically confirmed initial diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
- Has clinically nonmetastatic bladder cancer (N0M0)
- Has planned and is eligible to receive chemoradiotherapy (CRT) and one of the protocol-specified radiosensitizing chemotherapy regimens
- Has Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0, 1, or 2
- Demonstrates adequate organ function
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dosethe amount of medication taken of CRT treatment:
- Refrain from donating sperm
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days the time needed to eliminate each study intervention after the last dose of study intervention; and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: MK-3475 – 120 days and CRT – 180 days