ClinConnect ClinConnect Logo
Search / Trial NCT05007106

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

Launched by MERCK SHARP & DOHME LLC · Aug 10, 2021

Trial Information

Current as of June 20, 2025

Active, not recruiting

Keywords

Programmed Cell Death 1 (Pd1, Pd 1) Programmed Death Ligand 1 (Pdl1, Pd L1)

ClinConnect Summary

The clinical trial, known as KEYVIBE-005, is investigating a new treatment called MK-7684A, which combines two medications, pembrolizumab and vibostolimab. This trial focuses on patients with certain advanced solid tumors, including types of cervical cancer, endometrial cancer, and triple-negative breast cancer, among others. The main goal is to see if this combination treatment is safer and more effective than using pembrolizumab alone in helping patients respond to their cancer or live longer without their disease getting worse.

To participate in the trial, individuals should have one of the specified types of advanced cancer and meet other health criteria, such as having measurable disease and controlled blood pressure. Participants will receive either the MK-7684A treatment or the standard treatment and will be monitored closely for safety and effectiveness. It’s important to note that certain medical histories, like having received specific previous cancer treatments or having certain health conditions, may prevent someone from joining the trial. Overall, this study aims to improve treatment options for patients with challenging cancers.

Gender

ALL

Eligibility criteria

  • 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.

About Merck Sharp & Dohme Llc

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.

Locations

Milano, , Italy

New York, New York, United States

Anchorage, Alaska, United States

Duarte, California, United States

Orange, California, United States

Detroit, Michigan, United States

Middletown, New Jersey, United States

Commack, New York, United States

Harrison, New York, United States

Sioux Falls, South Dakota, United States

Houston, Texas, United States

Kingston, Ontario, Canada

Toronto, Ontario, Canada

Temuco, Araucania, Chile

Santiago, Region M. De Santiago, Chile

Santiago, Region M. De Santiago, Chile

Santiago, Region M. De Santiago, Chile

Medellin, Antioquia, Colombia

Barranquilla, Atlantico, Colombia

Bogotá, Cundinamarca, Colombia

Pereira, Risaralda, Colombia

Piedecuesta, Santander, Colombia

Dijon, Cote D Or, France

Montpellier, Herault, France

Villejuif, Paris, France

Lyon, Rhone Alpes, France

Avignon, Vaucluse, France

Paris, , France

Heidelberg, Baden Wurttemberg, Germany

Tübingen, Baden Wurttemberg, Germany

München, Bayern, Germany

Düsseldorf, Nordrhein Westfalen, Germany

Berlin, , Germany

Haifa, , Israel

Jerusalem, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Milano, , Italy

Napoli, , Italy

Kashiwa, Chiba, Japan

Tokyo, , Japan

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Amsterdam, Noord Holland, Netherlands

Rotterdam, Zuid Holland, Netherlands

Warszawa, Mazowieckie, Poland

Gdańsk, Pomorskie, Poland

Koszalin, Zachodniopomorskie, Poland

Hospitalet, Barcelona, Spain

Madrid, Madrid, Comunidad De, Spain

Pozuelo De Alarcon, Madrid, Spain

Sevilla, , Spain

Tainan, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan, , Taiwan

Istanbul Fatih, Istanbul, Turkey

Adana, , Turkey

Ankara, , Turkey

Ankara, , Turkey

Edirne, , Turkey

Istanbul, , Turkey

Istanbul, , Turkey

Taipei, , Taiwan

Temuco, Araucania, Chile

Milano, Lombardia, Italy

Toronto, Ontario, Canada

Barranquilla, Atlantico, Colombia

Temuco, Araucania, Chile

Osaka, , Japan

München, Bayern, Germany

Nagoya, Aichi, Japan

Taipei, , Taiwan

Tel Aviv, , Israel

Amsterdam, Noord Holland, Netherlands

Taipei, , Taiwan

Medellin, Antioquia, Colombia

Nagoya, Aichi, Japan

Toronto, Ontario, Canada

Nagoya, Aichi, Japan

Basking Ridge, New Jersey, United States

Ramat Gan, , Israel

Toronto, Ontario, Canada

Paris, , France

Madrid, , Spain

Orange, California, United States

Santiago, Region M. De Santiago, Chile

Tulsa, Oklahoma, United States

Roma, Lazio, Italy

Roma, Lazio, Italy

Taipei, , Taiwan

Montvale, New Jersey, United States

Uniondale, New York, United States

Gdansk, Pomorskie, Poland

Pereira, Risaralda, Colombia

Medellin, Antioquia, Colombia

Temuco, Araucania, Chile

Montpellier, Herault, France

Lyon, Rhone Alpes, France

Avignon, Vaucluse, France

Rozzano, Milano, Italy

Amsterdam, Noord Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Medical Director

Study Director

Merck Sharp & Dohme LLC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials