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BRIEF 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 (KEYNOTE-866)

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 (KEYNOTE-866)


  • Org Study ID: 3475-866
  • Secondary ID: 2018-003808-39,MK-3475-866,KEYNOTE-866
  • NCT ID: NCT03924856
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

Brief Summary

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

Overal Status Start Date Phase Study Type
Recruiting June 13, 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 4 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 4 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:

- Have a histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0)
with predominant (≥50%) urothelial histology (histology and presence of muscle invasion to
be confirmed by BICR): Participants with mixed histology are eligible provided the
urothelial component is ≥50%.

Participants whose tumors contain any neuroendocrine component are not eligible.

Urothelial carcinomas not originating from the bladder (e.g., upper tract [ureters, renal
pelvis], urethra) are not eligible.

- Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (computed
tomography (CT) chest or magnetic resonance imaging (MRI) of the abdomen/pelvis.

- Be deemed eligible for RC + PLND by his/her urologist and/or oncologist and agree to
undergo curative intent standard RC + PLND (including prostatectomy if applicable).

- Have a transurethral resection (TUR) of a bladder tumor that is submitted and adequate
to determine histology, muscle invasion, and PD-L1 status by central pathology vendor.

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Have demonstrated 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 anti-neoplastic treatment for MIBC.

- Is cisplatin-ineligible, as defined by meeting any one of the study criteria.

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
CTLA-4, OX-40, CD137).

- Has received therapy with hematopoietic growth factor such as granulocyte-colony
stimulating factor (G-CSF) or granulocyte-monocyte-colony stimulating factor(GM-CSF)
in 14 days prior to randomization.

- Has received prior systemic anti-cancer therapy including investigational agents
within 3 years of randomization.

- Has received any prior radiotherapy to the bladder.

- Has received a live vaccine within 30 days prior to the first dose of study drug.

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study intervention.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior the first dose of
study drug.

- Has hypersensitivity to monoclonal antibodies (mAbs, including pembrolizumab) and/or
any of their excipients.

- Has severe hypersensitivity (≥Grade 3) to cisplatin and/or gemcitabine and any of
their excipients.

- Has an active autoimmune disease that has required systemic treatment in past 2 years

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

- Has an active infection requiring systemic therapy.
Show More

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
New England Cancer Specialists ( Site 0070)
Scarborough, Maine 04074
United States
Recruiting Study Coordinator
207-303-3423
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma 74146
United States
Recruiting Study Coordinator
918-505-3200
Northwest Medical Specialties, PLLC ( Site 0061)
Tacoma, Washington 98405
United States
Recruiting Study Coordinator
253-428-8753
Southside Cancer Care Centre ( Site 1252)
Sydney, New South Wales 2228
Australia
Recruiting Study Coordinator
+61285569300
Peninsula Health Frankston Hospital ( Site 1258)
Frankston, Victoria 3199
Australia
Recruiting Study Coordinator
+61397848520
Rabin Medical Center ( Site 0804)
Petach Tikva, 4941492
Israel
Recruiting Study Coordinator
+97239378074
Sheba Medical Center ( Site 0801)
Ramat Gan, 5265601
Israel
Recruiting Study Coordinator
+97235302191
Sourasky Medical Center ( Site 0807)
Tel Aviv, 6423906
Israel
Recruiting Study Coordinator
+97236973413
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Gyeonggi-do 13620
Korea, Republic of
Recruiting Study Coordinator
+82317877351
Seoul National University Hospital ( Site 1352)
Seoul, 03080
Korea, Republic of
Recruiting Study Coordinator
+82220720361
Samsung Medical Center ( Site 1353)
Seoul, 06351
Korea, Republic of
Recruiting Study Coordinator
+82234103557
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala, 43-300
Poland
Recruiting Study Coordinator
+48606399091
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, 85-796
Poland
Recruiting Study Coordinator
+48501446778
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock, 05-400
Poland
Recruiting Study Coordinator
+48601200599
Magodent Szpital Elblaska ( Site 1051)
Warszawa, 01-748
Poland
Recruiting Study Coordinator
+48691666578
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw, 50-556
Poland
Recruiting Study Coordinator
+48601143281
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcon, Madrid 28223
Spain
Recruiting Study Coordinator
+34914521987
Hospital del Mar ( Site 0653)
Barcelona, 08003
Spain
Recruiting Study Coordinator
+34932483139
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona, 17007
Spain
Recruiting Study Coordinator
+349722258284028
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid, 28034
Spain
Recruiting Study Coordinator
+34913368263
Hospital Universitario San Carlos ( Site 0663)
Madrid, 28040
Spain
Recruiting Study Coordinator
+349133030007554
Hospital Universitario La Paz ( Site 0661)
Madrid, 28046
Spain
Recruiting Study Coordinator
+34912071138
Hospital Nuestra Sra. de Valme ( Site 0658)
Sevilla, 41014
Spain
Recruiting Study Coordinator
+34955015000