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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: N/A
  • NCT ID: NCT05007106
  • Sponsor: Merck Sharp & Dohme LLC

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:

Primary Outcome 1 - Timeframe: N/A

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 (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: Toll Free Number

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: Alaska Womens Cancer Care ( Site 1016)
Anchorage, Alaska 99508
United States
Status: Recruiting Contact: Contact
Study Coordinator
907-562-4673

Facility: City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Study Coordinator
626-471-9200

Facility: Karmanos Cancer Institute ( Site 1007)
Detroit, Michigan 48201
United States
Status: Recruiting Contact: Contact
Study Coordinator
734-330-6512

Facility: Memorial Sloan Kettering - Basking Ridge ( Site 1023)
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: Contact
Study Coordinator
646-888-6950

Facility: Memorial Sloan Kettering - Monmouth ( Site 1022)
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: Contact
Study Coordinator
646-888-6950

Facility: Memorial Sloan Kettering- Commack ( Site 1021)
Commack, New York 11725
United States
Status: Recruiting Contact: Contact
Study Coordinator
646-888-6950

Facility: Memorial Sloan Kettering - Westchester ( Site 1020)
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Study Coordinator
646-888-6950

Facility: Memorial Sloan Kettering Cancer Center ( Site 1002)
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Study Coordinator
646-888-6950

Facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
Tulsa, Oklahoma 74146
United States
Status: Recruiting Contact: Contact
Study Coordinator
918-505-3200

Facility: Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls, South Dakota 57104
United States
Status: Recruiting Contact: Contact
Study Coordinator
605-376-4905

Facility: Houston Methodist Hospital ( Site 1017)
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Study Coordinator
713-441-6616