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Closed (no longer recruiting)Last updated: 16 January 2024

KEYNOTE-866: This phase III trial is evaluating the effectiveness of administering a targeted therapy (Pembrolizumab) in combination with chemotherapy drugs (Gemcitabine and Cisplantin) before surgery to treat patients with bladder cancerA Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer

Clinical summary

Summary

Patients eligible to participate in this trial will receive 4 pre-operative cycles of gemcitabine, cisplatin and pembrolizumab or a placebo. After surgery, 13 cycles of pembrolizumab or placebo will be received.

Conditions

This trial is treating patients with Bladder cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

KEYNOTE-866

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT03924856
  • 3475-866, 2018-003808-39, MK-3475-866, 194870

Trial sponsor

Merck

Scientific Title

A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer

Eligibility

Inclusion

  • 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

  • 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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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