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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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