A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Phase 1

• Conditions: Cis-eligible Muscle-invasive bladder cancer.; MedDRA version: 21.1Level: LLTClassification code: 10022877Term: Invasive bladder cancer Class: 10029104; MedDRA version: 21.0Level: LLTClassification code: 10022879Term: Invasive bladder cancer stage III Class: 10029104; MedDRA version: 21.0Level: LLTClassification code: 10022878Term: Invasive bladder cancer stage II Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501970-20-01
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 912

Inclusion Criteria

Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (=50%) urothelial histology., Have clinically non-metastatic bladder cancer (N=1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis., Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)., Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1., Have adequate organ function., Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria

Has a known additional malignancy that is progressing or has required active anti-cancer treatment =3 years of study randomization with certain exceptions., Has had an allogenic tissue/solid organ transplant., Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)., Has =N2 disease or metastatic disease (M1) as identified by imaging., Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol., Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder., Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC., Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention., Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection., Has a known psychiatric or substance abuse disorder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified