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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Neoplasms; Stomach Neoplasms; Urinary Bladder Neoplasms; Hepatocellular Carcinoma; Esophageal Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Squamous Cell Carcinoma of Head and Neck; Cholangiocarcinoma; Triple Negative Breast Neoplasms; Gallbladder Neoplasms
• Intervention / Treatment: Biological: Pembrolizumab/Vibostolimab Co-Formulation; Biological: Pembrolizumab; Drug: Lenvatinib; Drug: 5-Fluorouracil; Drug: Cisplatin; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Docetaxel; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre ( Site 1056)
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • James Lind Centro de Investigacion del Cancer ( Site 1404)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 7500921
      • FALP-UIDO ( Site 1401)
    • Santiago, Region M. De Santiago, Chile, 7510032
      • Oncovida ( Site 1405)
    • Santiago, Region M. De Santiago, Chile, 8420383
      • Bradfordhill-Clinical Area ( Site 1402)
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050030
      • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Clinica de la Costa S.A.S. ( Site 1421)
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 111511
      • Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
  • Risaralda
    • Pereira, Risaralda, Colombia, 661001
      • Oncologos del Occidente ( Site 1424)
  • Santander
    • Piedecuesta, Santander, Colombia, 681017
      • Fundación Cardiovascular de Colombia ( Site 1423)
• France
  • Paris, France, 75248
    • Institut Curie ( Site 1152)
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21079
      • Centre Georges François Leclerc ( Site 1155)
  • Herault
    • Montpellier, Herault, France, 34298
      • Institut Regional du Cancer Montpellier ( Site 1157)
  • Paris
    • Villejuif, Paris, France, 94800
      • Gustave Roussy-medicine departement ( Site 1153)
  • Rhone-Alpes
    • Lyon, Rhone-Alpes, France, 69373 Cedex 08
      • CENTRE LEON BERARD-Medical oncology ( Site 1151)
  • Vaucluse
    • Avignon, Vaucluse, France, 84000
      • Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
• Germany
  • Berlin, Germany, 12203
    • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
  • Bayern
    • München, Bayern, Germany, 81337
      • Klinikum der Universität München Großhadern ( Site 1176)
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Oncology ( Site 1141)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center-Oncology ( Site 1142)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center-ONCOLOGY ( Site 1144)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center-Oncology ( Site 1143)
• Italy
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • Ospedale San Raffaele-Oncologia Medica ( Site 1135)
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)
• Japan
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute ( Site 1323)
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital ( Site 1322)
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital ( Site 1324)
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East ( Site 1321)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital-Internal Medicine ( Site 1312)
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center ( Site 1313)
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066CX
      • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-952
      • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
  • Zachodniopomorskie
    • Koszalin, Zachodniopomorskie, Poland, 75-581
      • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
• Spain
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
  • Sevilla, Spain, 41013
    • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
  • Barcelona
    • Hospitalet, Barcelona, Spain, 08907
      • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28034
      • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
• Taiwan
  • Tainan, Taiwan, 704
    • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital-Oncology ( Site 1301)
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital ( Site 1305)
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
• Turkey
  • Adana, Turkey, 01250
    • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi-oncology hospital ( Site 1209)
  • Ankara, Turkey, 06800
    • Ankara City Hospital-Medical Oncology ( Site 1202)
  • Edirne, Turkey, 22030
    • Trakya University-Medical Oncology ( Site 1207)
  • Istanbul, Turkey, 34303
    • Acibadem Universitesi Atakent Hastanesi ( Site 1208)
  • Istanbul, Turkey, 34722
    • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
  • Istanbul
    • Istanbul- Fatih, Istanbul, Turkey, 34098
      • Istanbul Universitesi Cerrahpasa ( Site 1203)
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Womens Cancer Care ( Site 1016)
  • California
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center ( Site 1001)
    • Orange, California, United States, 92868-3201
      • University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute ( Site 1007)
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering - Basking Ridge ( Site 1023)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering - Monmouth ( Site 1022)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering - Bergen ( Site 1025)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering- Commack ( Site 1021)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering - Westchester ( Site 1020)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center ( Site 1002)
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering - Nassau ( Site 1026)
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital ( Site 1017)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab; Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.	Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®
Experimental: Pembrolizumab/Vibostolimab Co-Formulation; Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy.	Biological: Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W; Other Names: MK-7684A; Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®
Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort); Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.	Biological: Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W; Other Names: MK-7684A; Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: Lenvatinib; Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD; Other Names: E7080; Lenvima; MK-7902
Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort); Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight [BW] ≥60 kg) or lenvatinib 8 mg (BW <60 kg) qd up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.	Biological: Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W; Other Names: MK-7684A; Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: Lenvatinib; Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD; Other Names: E7080; Lenvima; MK-7902
Experimental: Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin; Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin.	Biological: Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W; Other Names: MK-7684A; Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: 5-Fluorouracil; 5-FU 800 mg/m^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles; Other Names: 5-FU; Fluracil; Drug: Cisplatin; Cisplatin administered via IV infusion; Other Names: Platinol; cis Platinum
Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel; Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel.	Biological: Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W; Other Names: MK-7684A; Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; Paclitaxel administered via IV infusion at investigator's choice of dose; Other Names: Taxol; Abraxane; Anzatax
Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin; Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin	Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: Cisplatin; Cisplatin administered via IV infusion; Other Names: Platinol; cis Platinum; Drug: Gemcitabine; Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
Experimental: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab; Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab.	Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; Paclitaxel administered via IV infusion at investigator's choice of dose; Other Names: Taxol; Abraxane; Anzatax; Drug: Carboplatin; Carboplatin administered via IV infusion at investigator's choice of dose and frequency; Drug: Docetaxel; For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles; Drug: Bevacizumab; Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin; Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin.	Biological: Pembrolizumab; Pembrolizumab 200 mg administered via IV infusion Q3W.; Other Names: MK-3475; KEYTRUDA®; Drug: Capecitabine; Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles; Drug: Oxaliplatin; Oxaliplatin administered via IV infusion Q3W up to 35 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.	Up to approximately 2 years
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.	Up to approximately 2 years
PFS per RECIST 1.1 as Assessed by Investigator at 9 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.	9 months
PFS per RECIST 1.1 as Assessed by Investigator at 12 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.	12 months
ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors	ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR per RECIST 1.1 as Assessed by Investigator	ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented.	Up to approximately 2 years
PFS per RECIST 1.1 as Assessed by Investigator	PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.	Up to approximately 2 years
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR will be presented.	Up to approximately 2 years
DOR per RECIST 1.1 as Assessed by Investigator	For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by investigator will be presented.	Up to approximately 2 years
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30)	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.	Baseline and up to approximately 2 years
Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.	Baseline and up to approximately 2 years
Number of Participants Who Experienced One or More Adverse Events (AEs)	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 2 years
Number of Participants Who Discontinued Study Intervention Due to an AE	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 2 years
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 5.5 years
PFS per RECIST 1.1 as Assessed by Investigator in Participants with Cervical Cancer	PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): August 5, 2025
• Study Completion (Actual): August 5, 2025

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Esophageal Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Urologic Neoplasms; Uterine Cervical Diseases; Uterine Neoplasms; Urinary Bladder Diseases; Carcinoma, Squamous Cell; Gallbladder Diseases; Biliary Tract Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Stomach Neoplasms; Carcinoma; Esophageal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Cholangiocarcinoma; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms; Endometrial Neoplasms; Gallbladder Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Protein Kinase Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Docetaxel; Capecitabine; Oxaliplatin; Bevacizumab; Gemcitabine; Fluorouracil; Carboplatin; Pembrolizumab; Lenvatinib
• Other Study ID Numbers: 7684A-005; MK-7684A-005 (Other Identifier: MSD); jRCT2031210335 (Registry Identifier: jRCT); KEYVIBE-005 (Other Identifier: MSD); 2021-001009-56 (EudraCT Number); U1111-1291-4290 (Registry Identifier: UTN); 2023-505284-36-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No