Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting
Phase 3

Conditions

Bladder Cancer

Treatments

Drug: Gemcitabine
Drug: Placebo
Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Drug: Pembrolizumab
Drug: Cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03924856
2080224790 (Registry Identifier)
2022-501970-20-00 (Other Identifier)
2018-003808-39 (EudraCT Number)
3475-866
MK-3475-866 (Other Identifier)
194870 (Registry Identifier)
KEYNOTE-866 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

907 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.
  • Has had an allogenic tissue/solid organ transplant.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

907 participants in 2 patient groups, including a placebo group

Pembrolizumab + Gemcitabine + Cisplatin + Surgery
Experimental group
Description:
Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.
Treatment:
Drug: Cisplatin
Drug: Pembrolizumab
Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Drug: Gemcitabine
Placebo + Gemcitabine + Cisplatin + Surgery
Placebo Comparator group
Description:
Participants received 4 preoperative cycles of placebo to pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative placebo to pembrolizumab.
Treatment:
Drug: Cisplatin
Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Drug: Placebo
Drug: Gemcitabine

Trial contacts and locations

175

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Data sourced from clinicaltrials.gov

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