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

April 23, 2024 updated by: Merck Sharp & Dohme LLC

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

610

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Active, not recruiting
        • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
      • Toronto, Ontario, Canada, M5G 2M9
        • Active, not recruiting
        • Princess Margaret Cancer Centre ( Site 1056)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigación del Cáncer ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +56961064692
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7510032
        • Recruiting
        • Oncovida ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +56961064692
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +56961064692
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +56939263055
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050030
        • Recruiting
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 1422)
        • Contact:
          • Study Coordinator
          • Phone Number: +573126867004
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Recruiting
        • Clinica de la Costa S.A.S. ( Site 1421)
        • Contact:
          • Study Coordinator
          • Phone Number: +575 3369999
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 111511
        • Recruiting
        • Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
        • Contact:
          • Study Coordinator
          • Phone Number: 573125199934
    • Risaralda
      • Pereira, Risaralda, Colombia, 660001
        • Recruiting
        • Oncologos del Occidente ( Site 1424)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 6 3310712 Ext. 417
    • Santander
      • Piedecuesta, Santander, Colombia, 681017
        • Recruiting
        • Fundación Cardiovascular de Colombia ( Site 1423)
        • Contact:
          • Study Coordinator
          • Phone Number: 573215433439
  • France
      • Paris, France, 75248
        • Recruiting
        • Institut Curie ( Site 1152)
        • Contact:
          • Study Coordinator
          • Phone Number: 33144324086
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Recruiting
        • Centre Georges François Leclerc ( Site 1155)
        • Contact:
          • Study Coordinator
          • Phone Number: 03 45 34 80 68
    • Herault
      • Montpellier, Herault, France, 34298
        • Recruiting
        • Institut Régional du Cancer Montpellier ( Site 1157)
        • Contact:
          • Study Coordinator
          • Phone Number: 33467612304
    • Paris
      • Villejuif, Paris, France, 94800
        • Recruiting
        • Gustave Roussy-medicine departement ( Site 1153)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142114571
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France, 69008
        • Recruiting
        • CENTRE LEON BERARD-Medical oncology ( Site 1151)
        • Contact:
          • Study Coordinator
          • Phone Number: 33478782935
    • Vaucluse
      • Avignon, Vaucluse, France, 84918
        • Recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
        • Contact:
          • Study Coordinator
          • Phone Number: 33490276397
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 30 84450
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
        • Contact:
          • Study Coordinator
          • Phone Number: +4962215636051
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
        • Contact:
          • Study Coordinator
          • Phone Number: +4970712982795
    • Bayern
      • München, Bayern, Germany, 81337
        • Recruiting
        • Klinikum der Universität München Großhadern ( Site 1176)
        • Contact:
          • Study Coordinator
          • Phone Number: +4989 4400 75250
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
        • Contact:
          • Study Coordinator
          • Phone Number: +492118117820
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology ( Site 1141)
        • Contact:
          • Study Coordinator
          • Phone Number: + 972 4 7776724
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center-Oncology ( Site 1142)
        • Contact:
          • Study Coordinator
          • Phone Number: + 972 2 6776760
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-ONCOLOGY ( Site 1144)
        • Contact:
          • Study Coordinator
          • Phone Number: + 972 3 5302243
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center-Oncology ( Site 1143)
        • Contact:
          • Study Coordinator
          • Phone Number: + 972 3 6973082
  • Italy
      • Milano, Italy, 20141
        • Completed
        • Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
        • Contact:
          • Study Coordinator
          • Phone Number: 00393331891929
    • Lazio
      • Roma, Lazio, Italy, oo168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
        • Contact:
          • Study Coordinator
          • Phone Number: 390630158545
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 1135)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226436523
  • Japan
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute ( Site 1323)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
      • Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital ( Site 1322)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3542-2511
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital ( Site 1324)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-762-6111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 1321)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2228-8132
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center ( Site 1313)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3010-0491
      • Seoul, Korea, Republic of, 03080
        • Active, not recruiting
        • Seoul National University Hospital-Internal Medicine ( Site 1312)
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)
        • Contact:
          • Study Coordinator
          • Phone Number: +31205122446
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
        • Contact:
          • Study Coordinator
          • Phone Number: +31107034897
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
        • Contact:
          • Study Coordinator
          • Phone Number: +48 22 546 33 81
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 695 802 353
    • Zachodniopomorskie
      • Koszalin, Zachodniopomorskie, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: 48502204953
  • Spain
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
        • Contact:
          • Study Coordinator
          • Phone Number: 913531920
      • Sevilla, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
        • Contact:
          • Study Coordinator
          • Phone Number: +34955013068
    • Barcelona
      • Hospitalet, Barcelona, Spain, 08907
        • Recruiting
        • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
        • Contact:
          • Study Coordinator
          • Phone Number: 932607294
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
        • Contact:
          • Study Coordinator
          • Phone Number: 34914521987
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 913368263
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-6-2353535
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: +886 2 2543 3535
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-23123456
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-3-3281200
  • Turkey
      • Adana, Turkey, 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +903223444445
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universitesi-oncology hospital ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: 90 312 305 29 29
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara City Hospital-Medical Oncology ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 0903125526000
      • Edirne, Turkey, 22030
        • Recruiting
        • Trakya University-Medical Oncology ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: 90 284 235 76 41
      • Istanbul, Turkey, 34303
        • Recruiting
        • Acibadem Universitesi Atakent Hastanesi ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324634021
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: 90 216 606 52 00
    • Istanbul
      • Istanbul- Fatih, Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 2124400000
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Womens Cancer Care ( Site 1016)
        • Contact:
          • Study Coordinator
          • Phone Number: 907-562-4673
    • California
      • Duarte, California, United States, 91010
        • Completed
        • City of Hope Comprehensive Cancer Center ( Site 1001)
      • Orange, California, United States, 92868-3201
        • Completed
        • University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-527-6266
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering - Basking Ridge ( Site 1023)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering - Monmouth ( Site 1022)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering - Bergen ( Site 1025)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering- Commack ( Site 1021)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering - Westchester ( Site 1020)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering - Nassau ( Site 1026)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-6950
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
        • Contact:
          • Study Coordinator
          • Phone Number: 918-505-3200
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-376-4905
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital ( Site 1017)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-441-6616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Names:
  • MK-7684A
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 + 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) until meeting discontinuation criteria.
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Names:
  • MK-7684A
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 until meeting discontinuation criteria.
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Names:
  • MK-7684A
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.
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Names:
  • MK-7684A
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.
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Names:
  • MK-7684A
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.
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 background therapy.
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.
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)
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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
Time Frame: 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
Time Frame: 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
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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)
Time Frame: Baseline and up to approximately 2 years
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)
Time Frame: Baseline and up to approximately 2 years
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)
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
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)
Time Frame: Up to approximately 5.5 years
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
Time Frame: Up to approximately 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Estimated)

February 22, 2027

Study Completion (Estimated)

February 22, 2027

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)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-005
  • MK-7684A-005 (Other Identifier: Merck)
  • jRCT2031210335 (Registry Identifier: jRCT)
  • KEYVIBE-005 (Other Identifier: Merck)
  • 2021-001009-56 (EudraCT Number)
  • 2023-505284-36 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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