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

NCT05007106 | Completed Phase 2 FDA Drug

• 7 other identifiers: 7684A-005MK-7684A-005jRCT2031210335KEYVIBE-0052023-505284-36-00U1111-1291-42902021-001009-56
• Study Type: interventional
• Target: 613
• Locations: 15 countries
• Sites: 73

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.

Conditions

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

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

Secondary Outcomes (10)

• Overall Survival (OS)

  Up to approximately 5.5 years

• PFS per RECIST 1.1 as Assessed by Investigator

  Up to approximately 2 years

• Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

  Up to approximately 2 years

• DOR per RECIST 1.1 as Assessed by Investigator

  Up to approximately 2 years

• ORR per RECIST 1.1 as Assessed by Investigator

  Up to approximately 2 years

Study Arms (9)

Pembrolizumab/Vibostolimab Co-Formulation

EXPERIMENTAL

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; Biological: Pembrolizumab

Pembrolizumab

EXPERIMENTAL

Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.

Biological: Pembrolizumab

Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)

EXPERIMENTAL

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; Biological: Pembrolizumab; Drug: Lenvatinib

Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)

EXPERIMENTAL

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; Biological: Pembrolizumab; Drug: Lenvatinib

Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin

EXPERIMENTAL

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; Biological: Pembrolizumab; Drug: 5-Fluorouracil; Drug: Cisplatin

Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel

EXPERIMENTAL

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; Biological: Pembrolizumab; Drug: Paclitaxel

Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Gemcitabine

Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab

EXPERIMENTAL

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; Drug: Paclitaxel; Drug: Carboplatin; Drug: Docetaxel; Drug: Bevacizumab

Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin

EXPERIMENTAL

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; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Pembrolizumab/Vibostolimab Co-Formulation BIOLOGICAL

Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W

Also known as: MK-7684A

Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin; Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort); Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort); Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel

Pembrolizumab BIOLOGICAL

Pembrolizumab 200 mg administered via IV infusion Q3W.

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab; Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin; Pembrolizumab/Vibostolimab Co-Formulation; Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin; Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin; Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort); Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort); Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel; Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab

Lenvatinib DRUG

Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD

Also known as: Lenvima, E7080, MK-7902

Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort); Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)

5-Fluorouracil DRUG

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

Also known as: 5-FU, Fluracil

Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin

Cisplatin DRUG

Cisplatin administered via IV infusion

Also known as: Platinol, cis Platinum

Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin; Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin

Paclitaxel DRUG

Paclitaxel administered via IV infusion at investigator's choice of dose

Also known as: Taxol, Abraxane, Anzatax

Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel; Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab

Gemcitabine DRUG

Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity

Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin

Carboplatin DRUG

Carboplatin administered via IV infusion at investigator's choice of dose and frequency

Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab

Docetaxel DRUG

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

Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab

Bevacizumab DRUG

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

Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab

Capecitabine DRUG

Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles

Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin

Oxaliplatin DRUG

Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (73)

Alaska Womens Cancer Care ( Site 1016)

Anchorage, Alaska, 99508, United States

Location

City of Hope Comprehensive Cancer Center ( Site 1001)

Duarte, California, 91010, United States

Location

University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente

Orange, California, 92868-3201, United States

Location

Karmanos Cancer Institute ( Site 1007)

Detroit, Michigan, 48201, United States

Location

Memorial Sloan Kettering - Basking Ridge ( Site 1023)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering - Monmouth ( Site 1022)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering - Bergen ( Site 1025)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering- Commack ( Site 1021)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering - Westchester ( Site 1020)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 1002)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering - Nassau ( Site 1026)

Uniondale, New York, 11553, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)

Tulsa, Oklahoma, 74146, United States

Location

Sanford Cancer Center-Gynecologic Oncology ( Site 1015)

Sioux Falls, South Dakota, 57104, United States

Location

Houston Methodist Hospital ( Site 1017)

Houston, Texas, 77030, United States

Location

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)

Kingston, Ontario, K7L 2V7, Canada

Location

Princess Margaret Cancer Centre ( Site 1056)

Toronto, Ontario, M5G 2M9, Canada

Location

FALP-UIDO ( Site 1401)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Oncovida ( Site 1405)

Santiago, Region M. de Santiago, 7510032, Chile

Location

Bradfordhill-Clinical Area ( Site 1402)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigacion del Cancer ( Site 1404)

Temuco, Región de la Araucanía, 4800827, Chile

Location

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)

Medellín, Antioquia, 050030, Colombia

Location

Clinica de la Costa S.A.S. ( Site 1421)

Barranquilla, Atlántico, 080020, Colombia

Location

Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)

Bogotá, Cundinamarca, 111511, Colombia

Location

Oncologos del Occidente ( Site 1424)

Pereira, Risaralda Department, 661001, Colombia

Location

Fundación Cardiovascular de Colombia ( Site 1423)

Piedecuesta, Santander Department, 681017, Colombia

Location

CENTRE LEON BERARD-Medical oncology ( Site 1151)

Lyon, Auvergne-Rhône-Alpes, 69373 Cedex 08, France

Location

Centre Georges François Leclerc ( Site 1155)

Dijon, Cote-d Or, 21079, France

Location

Institut Regional du Cancer Montpellier ( Site 1157)

Montpellier, Herault, 34298, France

Location

Gustave Roussy-medicine departement ( Site 1153)

Villejuif, Paris, 94800, France

Location

Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)

Avignon, Vaucluse, 84000, France

Location

Institut Curie ( Site 1152)

Paris, 75248, France

Location

Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum der Universität München Großhadern ( Site 1176)

München, Bavaria, 81337, Germany

Location

Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)

Berlin, 12203, Germany

Location

Rambam Health Care Campus-Oncology ( Site 1141)

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Oncology ( Site 1142)

Jerusalem, 9112001, Israel

Location

Sheba Medical Center-ONCOLOGY ( Site 1144)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center-Oncology ( Site 1143)

Tel Aviv, 6423906, Israel

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)

Rome, Lazio, 00168, Italy

Location

Ospedale San Raffaele-Oncologia Medica ( Site 1135)

Milan, Lombardy, 20132, Italy

Location

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)

Rozzano, Milano, 20089, Italy

Location

Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

Milan, 20141, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)

Napoli, 80131, Italy

Location

Aichi Cancer Center Hospital ( Site 1324)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 1321)

Kashiwa, Chiba, 277-8577, Japan

Location

Osaka International Cancer Institute ( Site 1323)

Osaka, 541-8567, Japan

Location

National Cancer Center Hospital ( Site 1322)

Tokyo, 104-0045, Japan

Location

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)

Amsterdam, North Holland, 1066CX, Netherlands

Location

Erasmus Medisch Centrum-Medical Oncology ( Site 1122)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

Location

Seoul National University Hospital-Internal Medicine ( Site 1312)

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 1313)

Seoul, 05505, South Korea

Location

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)

Hospitalet, Barcelona, 08907, Spain

Location

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Clinica Universidad de Navarra-Medical Oncology ( Site 1118)

Madrid, 28027, Spain

Location

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)

Seville, 41013, Spain

Location

NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital-Oncology ( Site 1301)

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital ( Site 1305)

Taipei, 10449, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 1304)

Taoyuan District, 333, Taiwan

Location

Istanbul Universitesi Cerrahpasa ( Site 1203)

Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)

Location

Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Universitesi-oncology hospital ( Site 1209)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara City Hospital-Medical Oncology ( Site 1202)

Ankara, 06800, Turkey (Türkiye)

Location

Trakya University-Medical Oncology ( Site 1207)

Edirne, 22030, Turkey (Türkiye)

Location

Acibadem Universitesi Atakent Hastanesi ( Site 1208)

Istanbul, 34303, Turkey (Türkiye)

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)

Istanbul, 34722, Turkey (Türkiye)

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Squamous Cell Carcinoma of Head and Neck; Gallbladder Neoplasms; Cholangiocarcinoma; Esophageal Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Hepatocellular; Urinary Bladder Neoplasms; Ovarian Neoplasms; Stomach Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; lenvatinib; Fluorouracil; Cisplatin; Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Carboplatin; Docetaxel; Bevacizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Gastrointestinal Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Liver Neoplasms; Liver Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with locally recurrent unresectable or metastatic cervical cancer whose tumors express programmed cell death 1 ligand 1 (PD-LI) and have a combined positive score (CPS) ≥1 will be randomly assigned to treatment with either pembrolizumab/vibostolimab co-formulation or pembrolizumab only. The other study intervention arms will be assigned to participants depending on the selected cancer type.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 16, 2021
• Study Start: September 16, 2021
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (4); KR (3); ES (5); TW (4); CO (5); TU (7); CL (4); FR (6); DE (5); NL (2); IT (5); IL (4); PL (3); CA (2); US (14)