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Brief Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

INTRODUCTION

  • Org Study ID: 7684A-005
  • Secondary ID: MK-7684A-005, jRCT2031210335, KEYVIBE-005, 2021-001009-56
  • NTC ID: NCT05007106
  • Sponsor: Merck Sharp & Dohme LLC
Merck Oncology Clinical Trials Information

BRIEF SUMMARY

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

  • Overall Status
    Recruiting
  • Start Date
    September 16, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Primary Outcome 1 - Timeframe: Up to approximately 2 years

Primary Outcome 2 - Measure: Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR

Primary Outcome 2 - Timeframe: Up to approximately 2 years

Primary Outcome 3 - Measure: ORR per RECIST 1.1 as Assessed by Investigator

Primary Outcome 3 - Timeframe: Up to approximately 2 years

Primary Outcome 4 - Measure: PFS per RECIST 1.1 as Assessed by Investigator at 9 months

Primary Outcome 4 - Timeframe: 9 months

Primary Outcome 5 - Measure: PFS per RECIST 1.1 as Assessed by Investigator at 12 months

Primary Outcome 5 - Timeframe: 12 months

CONDITION

  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Esophageal Neoplasms
  • Triple Negative Breast Neoplasms
  • Hepatocellular Carcinoma
  • Urinary Bladder Neoplasms
  • Ovarian Neoplasms
  • Stomach Neoplasms

ELIGIBILITY

Inclusion Criteria:
One of the following histologically or cytologically confirmed, advanced (locally recurrent unresectable or metastatic) solid tumors:
Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

- Endometrial cancer

- Head and neck squamous cell carcinoma (HNSCC)

- Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)

- Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).

- Triple-negative breast cancer (TNBC)

- Hepatocellular carcinoma (HCC)

- Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra

- Ovarian cancer

- Gastric cancer

- Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.

- Adequately controlled blood pressure (BP) with or without antihypertensive medications.

- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

- Male participants must agree to follow contraceptive guidance.

- Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.

- Adequate organ function.
Exclusion Criteria:
History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.

- Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.

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

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

- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.

- Active autoimmune disease that has required systemic treatment in past 2 years.

- Active infection requiring systemic therapy.

- Concurrent active hepatitis B and hepatitis C virus infection.

- History of allogenic tissue/solid organ transplant.

- Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).

- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

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