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BRIEF TITLE: Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)


  • Org Study ID: 3475-B15
  • Secondary ID: MK-3475-B15,KEYNOTE-B15,EV-304,2020-003106-31,jRCT2041210011
  • NCT ID: NCT04700124
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

Brief Summary

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

Overal Status Start Date Phase Study Type
Recruiting April 21, 2021 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic Complete Response (pCR) Rate

Primary Outcome 1 - Time Frame: Up to approximately 15 Weeks (Time of surgery)

Primary Outcome 2 - Measure: Event-Free Survival (EFS)

Primary Outcome 2 - Time Frame: Up to approximately 58 months

Condition:

  • Muscle Invasive Bladder Cancer

Eligibility

Criteria:
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

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

- Has ongoing sensory or motor neuropathy Grade 2 or higher

- Has active keratitis (superficial punctate keratitis) or corneal ulcerations

- Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c
7% to <8% with associated diabetes symptoms
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme Corp.

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: Trialsites@merck.com

Locations

Facility Status Contact
White Plains Hospital ( Site 0039)
White Plains, New York 10601
United States
Recruiting Study Coordinator
914-849-7630
MidLantic Urology ( Site 0002)
Bala-Cynwyd, Pennsylvania 19004
United States
Recruiting Study Coordinator
999-999-9999
Saint Francis Cancer Center ( Site 0008)
Greenville, South Carolina 29607
United States
Recruiting Study Coordinator
863-603-6300
Chonnam National University Hwasun Hospital ( Site 1353)
Jeollanam-do, Jeonranamdo 58128
Korea, Republic of
Recruiting Study Coordinator
+82613797745
Seoul National University Bundang Hospital ( Site 1355)
Gyeonggi-do, Kyonggi-do 13620
Korea, Republic of
Recruiting Study Coordinator
+82317877351