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BRIEF TITLE: A Phase 3 Randomized Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-905)

A Phase 3 Randomized Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-905)


  • Org Study ID: 3475-905
  • Secondary ID: MK-3475-905,2018-003809-26,KEYNOTE-905
  • NCT ID: NCT03924895
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

Brief Summary

A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Overal Status Start Date Phase Study Type
Recruiting June 30, 2019 Phase 3 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Up to approximately 3 months (Time of surgery)

Primary Outcome 2 - Measure: Pathologic Complete Response Rate in Participants Whose Tumors Express PD-L1 Combined Positive Score (CPS) ≥10

Primary Outcome 2 - Time Frame: Up to approximately 3 months (Time of surgery)

Primary Outcome 3 - Measure: Event-Free Survival (EFS) in All Participants

Primary Outcome 3 - Time Frame: Up to approximately 5.5 years

Primary Outcome 4 - Measure: Event-Free Survival in Participants Whose Tumors Express PD-L1, CPS ≥10

Primary Outcome 4 - Time Frame: Up to approximately 5.5 years

Condition:

  • Urinary Bladder Cancer, Muscle-invasive

Eligibility

Criteria:
Inclusion Criteria:

- Histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with
predominant (≥50%) urothelial histology. Participants with mixed histology are
eligible provided the urothelial component is ≥50%. Urothelial carcinomas not
originating from the bladder are not eligible. Participants whose tumors contain any
neuroendocrine component are not eligible.

- Clinically non-metastatic bladder cancer determined by imaging

- Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND ), and
agreement to undergo curative intent standard RC + PLND (including prostatectomy if
applicable)

- Ineligible for treatment with cisplatin, as defined by meeting at least one of the
following criteria:

- Impaired renal function with measured or calculated CrCl 30 to 59 mL/min

- Eastern Cooperative Oncology Group (ECOG) Performance Status 2

- Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric
hearing loss

- CTCAE v.4 Grade ≥2 peripheral neuropathy

- New York Heart Association (NYHA) Class III heart failure

- Transurethral resection (TUR) of a bladder tumor that is submitted and adequate for
evaluation of histology, muscle invasion and PD-L1 status

- ECOG performance status of 0, 1, or 2

- Adequate organ function

Exclusion Criteria:

- Known additional non-urothelial malignancy that is progressing or has required active
treatment ≤3 years of study randomization, with certain exceptions

- Received any prior systemic anti-neoplastic treatment for muscle-invasive bladder
cancer (MIBC)

- Received prior therapy with a anti-programmed cell death protein 1 (PD-1),
anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2
(PD-L2), or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor

- Received prior systemic anti-cancer therapy including investigational agents within 3
years prior to randomization

- Received any prior radiotherapy to the bladder

- Received a live vaccine within 30 days prior to the first dose of study drug

- Current participation in or participation in a study of an investigational agent or
use of an investigational device within 4 weeks prior to the first dose of study
intervention

- Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior the first dose of study
drug

- Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of
their excipients

- Active autoimmune disease that has required systemic therapy in past 2 years (i.e.,
with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) is not considered a form
of systemic therapy and is allowed.

- History of (non-infectious) pneumonitis that required steroids, or current
pneumonitis.

- Active infection requiring systemic therapy
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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
Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana 46845
United States
Recruiting Study Coordinator
260-266-9167
Greater Baltimore Medical Center ( Site 0014)
Baltimore, Maryland 21204
United States
Recruiting Study Coordinator
443-849-3285
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma 74146
United States
Recruiting Study Coordinator
918-505-3200
Carolina Urologic Research Center ( Site 0062)
Myrtle Beach, South Carolina 29572
United States
Recruiting Study Coordinator
8434491010257
Urology Associates [Nashville, TN] ( Site 0053)
Nashville, Tennessee 37209
United States
Recruiting Study Coordinator
615-250-9268
Sheba Medical Center ( Site 0844)
Ramat Gan, 5265601
Israel
Recruiting Study Coordinator
+97235302191
Sourasky Medical Center ( Site 0850)
Tel Aviv, 6423906
Israel
Recruiting Study Coordinator
+97236973413
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, 85-796
Poland
Recruiting Study Coordinator
+48501446778
Szpital Wojewodzki ( Site 1062)
Tarnow, 33-100
Poland
Recruiting Study Coordinator
+48602280826
Hospital del Mar ( Site 0698)
Barcelona, 08003
Spain
Recruiting Study Coordinator
+34932483139
Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700)
Girona, 17007
Spain
Recruiting Study Coordinator
+349722258284028
Hospital Universitario Ramon y Cajal ( Site 0691)
Madrid, 28034
Spain
Recruiting Study Coordinator
+34913368263
Hospital Universitario San Carlos ( Site 0678)
Madrid, 28040
Spain
Recruiting Study Coordinator
+34913303000ext7554
Hospital Universitario la Paz ( Site 0690)
Madrid, 28046
Spain
Recruiting Study Coordinator
+34912071138