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Brief Title: A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A

INTRODUCTION

  • Org Study ID: 3475-04A
  • Secondary ID: MK-3475-04A, 2020-004544-28
  • NCT ID: NCT05562830
  • Sponsor: Merck Sharp & Dohme LLC
Merck Oncology Clinical Trials Information

BRIEF SUMMARY

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.

  • Overall Status
    Recruiting
  • Start Date
    November 16, 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Percentage of Participants Who Experienced At Least One Adverse Event (AE)

Primary Outcome 1 - Timeframe: Up to approximately 5 years

Primary Outcome 2 - Measure: Percentage of Participants Who Discontinued Study Treatment Due to an AE

Primary Outcome 2 - Timeframe: Up to approximately 5 years

Primary Outcome 3 - Measure: Objective Response Rate (ORR)

Primary Outcome 3 - Timeframe: Up to approximately 2 years

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.

- PD-1/L1 refractory locally advanced or mUC as evidenced by:
EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation.
Exclusion Criteria:
Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation.

- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.

- Active infection requiring systemic therapy.

- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.

- Known history of human immunodeficiency virus (HIV).

- Known history of hepatitis B or known hepatitis C virus infection.

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 LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Study Coordinator
502-472-3237

Facility: Anschutz Cancer Pavilion ( Site 1017)
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Study Coordinator
303-724-0499

Facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Contact
Study Coordinator
317-944-0920

Facility: Cleveland Clinic-Taussig Cancer Center ( Site 1036)
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Study Coordinator
216-296-5457

Facility: UPMC Hillman Cancer Center ( Site 1014)
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Study Coordinator
412-623-4759

Facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland 4029
Australia
Status: Recruiting Contact: Contact
Study Coordinator
+61736467712

Facility: FALP-UIDO ( Site 1151)
Santiago, Region M. De Santiago 6900941
Chile
Status: Recruiting Contact: Contact
Study Coordinator
56224457254

Facility: Bradfordhill-Clinical Area ( Site 1155)
Santiago, Region M. De Santiago 8420383
Chile
Status: Recruiting Contact: Contact
Study Coordinator
+56998744662

Facility: Rigshospitalet-Dept. of Oncology ( Site 1701)
Copenhagen, Hovedstaden 2100
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
4535458403

Facility: Rambam Health Care Campus-Oncology ( Site 1501)
Haifa, 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
97247776750

Facility: Rabin Medical Center-Oncology ( Site 1504)
Petah Tikva, 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+972-39378074

Facility: Sheba Medical Center-ONCOLOGY ( Site 1503)
Ramat Gan, 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
0525505090

Facility: Severance Hospital, Yonsei University Health System ( Site 1903)
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82222288138

Facility: Asan Medical Center ( Site 1901)
Seoul, 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82230105977

Facility: Samsung Medical Center ( Site 1902)
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82234103459

Facility: Hospital Universitari Vall d'Hebron ( Site 1767)
Barcelona, 08035
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34934894158

Facility: Hospital Clinico San Carlos ( Site 1765)
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34 913303000x7554