Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
mai 2020
juin 2031
27 septembre 2024
Researchers are looking for new ways to treat muscle-invasive bladder cancer (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 surgery to remove the bladder (cystectomy). 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
Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and
Radiation therapy (a treatment that uses beams of intense energy [like X-rays] to shrink
or get rid of tumors).
Pembrolizumab is an immunotherapy, 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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:45 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens Picardie Site Sud Amiens ( Site 0123) - 80000 - Amiens - Somme - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Institut Sainte Catherine ( Site 0121) - 84918 - Avignon - Provence-Alpes-Cote-d Azur - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Has a histologically confirmed initial diagnosis 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 Oncology 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 dose 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
- Has a histologically confirmed initial diagnosis 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 Oncology 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 dose 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
- Has the presence of diffuse carcinoma in situ (CIS) (multiple foci of CIS)
throughout the bladder
- Has the presence of urothelial carcinoma (UC) at any site outside of the urinary
bladder in the previous 2 years except for Ta stage/T1 stage/CIS of the upper tract
if the participant has undergone a complete nephroureterectomy
- Has a known additional malignancy that is progressing or has required active therapy
within the past 3 years, except basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, superficial bladder cancer or other carcinoma in situ that
has undergone potentially curative therapy
- Has the presence of bilateral hydronephrosis
- Has limited bladder function with frequency of small amounts of urine (< 30 mL),
urinary incontinence, or requires self-catheterization or a permanent indwelling
catheter
- Has received prior pelvic/local radiation therapy or any antineoplastic treatment
for muscle-invasive bladder cancer (MIBC). Treatment for non-muscle invasive bladder
cancer (NMIBC) with intravesical instillation therapy that was completed ≥28 days
prior to randomization is allowed. Prior systemic treatment of NMIBC is not
permitted.
- Received prior therapy with an anti-PD-1 (programmed cell death protein 1),
anti-PD-L1 (programmed death-ligand 1), or anti-PD-L2 (programmed cell death 1
ligand 2), or with an agent directed to another stimulatory or coinhibitory T-cell
receptor (e.g., CTLA-4 [cytotoxic T-lymphocyte-associated protein 4], OX 40, or
CD137 [cluster of differentiation 137])
- Has received a live vaccine within 30 days before the first dose of study medication
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks before the first dose of
study medication
- Has known severe hypersensitivity (≥Grade 3) to the selected chemotherapy regimen,
and/or any of their excipients and excipients of pembrolizumab
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days before the first dose of study medication
- Has an active autoimmune disease that has required systemic treatment in the past 2
years (ie, with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment and is allowed
- Has a history of non-infectious pneumonitis that required steroids or has current
pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B or known active hepatitis C virus infection
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
- Has a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study
- Has had an allogenic tissue/solid organ transplant