Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
décembre 2018
novembre 2034
26 avril 2025
Researchers are looking for new ways to treat high-risk non muscle invasive bladder
cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but
has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may
have a high chance of getting worse or coming back after treatment.
The goals of this study are to learn: 1. If more people who receive pembrolizumab with
Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer
without the cancer growing, spreading, or coming back compared to people who receive BCG
alone. 2. About the safety and how well people tolerate BCG 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 | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | YANN NEUZILLET | 05/05/2025 07:12:02 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | 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 | |||||
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353) - 35000 - Rennes - Ille-et-Vilaine - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355) - 21000 - Dijon - Bourgogne - France | Contact (sur clinicalTrials) | ||||
| Hopital Claude Huriez - CHU de Lille ( Site 1360) - 59037 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Have locally and blinded independent central review (BICR)-confirmed histological
diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the
bladder
- Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove
all resectable disease
- Has provided tissue for biomarker analysis
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Has adequate organ function
- During the treatment period and for ≥7 days after the last dose of BCG, male
participants are EITHER abstinent from heterosexual intercourse as their preferred
and usual lifestyle and agree to remain abstinent, OR, must agree to use
contraception unless confirmed to be azoospermic
- Female participants who are not pregnant, not breastfeeding, and either not a woman
of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception
method that is highly effective or remains abstinent from heterosexual intercourse
during the treatment period and for ≥7 days after the last dose of BCG or 120 days
after the last dose of pembrolizumab, whichever comes last
BCG Post-induction Cohort (Cohort A) Only
- Has been treated with one adequate course of BCG induction therapy for the treatment
of HR NMIBC
- Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
- Have locally and blinded independent central review (BICR)-confirmed histological
diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the
bladder
- Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove
all resectable disease
- Has provided tissue for biomarker analysis
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Has adequate organ function
- During the treatment period and for ≥7 days after the last dose of BCG, male
participants are EITHER abstinent from heterosexual intercourse as their preferred
and usual lifestyle and agree to remain abstinent, OR, must agree to use
contraception unless confirmed to be azoospermic
- Female participants who are not pregnant, not breastfeeding, and either not a woman
of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception
method that is highly effective or remains abstinent from heterosexual intercourse
during the treatment period and for ≥7 days after the last dose of BCG or 120 days
after the last dose of pembrolizumab, whichever comes last
BCG Post-induction Cohort (Cohort A) Only
- Has been treated with one adequate course of BCG induction therapy for the treatment
of HR NMIBC
- Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
- Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC
- Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle
invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC
- Has received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks of start of study treatment
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks of start of study
treatment
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days of start of study
treatment
- Has a known additional malignancy that is progressing or requires active treatment
within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2
years
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that
required steroids or has current pneumonitis/interstitial lung disease
- Has one or more of the following contraindications to BCG: prior BCG sepsis or
systemic infection, total bladder incontinence, or an adverse experience to a
previous BCG instillation that resulted in treatment discontinuation and precludes
retreating with BCG
- Has an active infection or diagnosis requiring systemic antimicrobial 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 current active tuberculosis
- Has had an allogenic-tissue/solid organ transplant
- Has any contraindication(s) to IV contrast or is otherwise unable to have screening
imaging with IV contrast performed
BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an
induction course of BCG
BCG Naïve Cohort (Cohort B) Only
- Has received any prior treatment with BCG for their NMIBC within the past 2 years
prior to study entry