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

Primary Purpose

Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab
Lenvatinib
5-Fluorouracil
Cisplatin
Paclitaxel
Gemcitabine
Carboplatin
Docetaxel
Bevacizumab
Capecitabine
Oxaliplatin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • One of the following histologically or cytologically confirmed, advanced (locally recurrent 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.

Sites / Locations

  • Alaska Womens Cancer Care ( Site 1016)Recruiting
  • City of Hope Comprehensive Cancer Center ( Site 1001)Recruiting
  • University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
  • Karmanos Cancer Institute ( Site 1007)Recruiting
  • Memorial Sloan Kettering - Basking Ridge ( Site 1023)Recruiting
  • Memorial Sloan Kettering - Monmouth ( Site 1022)Recruiting
  • Memorial Sloan Kettering- Commack ( Site 1021)Recruiting
  • Memorial Sloan Kettering - Westchester ( Site 1020)Recruiting
  • Memorial Sloan Kettering Cancer Center ( Site 1002)Recruiting
  • Sanford Cancer Center-Gynecologic Oncology ( Site 1015)Recruiting
  • Houston Methodist Hospital ( Site 1017)Recruiting
  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)Recruiting
  • Princess Margaret Cancer Centre ( Site 1056)Recruiting
  • James Lind Centro de Investigación del Cáncer ( Site 1404)Recruiting
  • FALP-UIDO ( Site 1401)Recruiting
  • Oncovida ( Site 1405)Recruiting
  • Bradfordhill-Clinical Area ( Site 1402)Recruiting
  • Fundación Colombiana de Cancerología Clínica Vida ( Site 1422)Recruiting
  • Clinica de la Costa S.A.S. ( Site 1421)Recruiting
  • Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)Recruiting
  • Oncologos del Occidente ( Site 1424)Recruiting
  • Fundación Cardiovascular de Colombia ( Site 1423)Recruiting
  • Centre Georges François Leclerc ( Site 1155)Recruiting
  • Institut Régional du Cancer Montpellier ( Site 1157)Recruiting
  • Gustave Roussy-medicine departement ( Site 1153)Recruiting
  • CENTRE LEON BERARD-Medical oncology ( Site 1151)Recruiting
  • Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)Recruiting
  • Institut Curie ( Site 1152)Recruiting
  • Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)Recruiting
  • Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, PneRecruiting
  • Klinikum der Universität München Großhadern ( Site 1176)Recruiting
  • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)Recruiting
  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)Recruiting
  • Rambam Health Care Campus-Oncology ( Site 1141)Recruiting
  • Hadassah Medical Center-Oncology ( Site 1142)Recruiting
  • Sheba Medical Center-ONCOLOGY ( Site 1144)Recruiting
  • Sourasky Medical Center-Oncology ( Site 1143)Recruiting
  • Ospedale San Raffaele-Oncologia Medica ( Site 1135)Recruiting
  • Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (Recruiting
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)Recruiting
  • Aichi Cancer Center Hospital ( Site 1324)Recruiting
  • National Cancer Center Hospital East ( Site 1321)Recruiting
  • Osaka International Cancer Institute ( Site 1323)Recruiting
  • National Cancer Center Hospital ( Site 1322)Recruiting
  • Seoul National University Hospital-Internal Medicine ( Site 1312)Recruiting
  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)Recruiting
  • Asan Medical Center ( Site 1313)Recruiting
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)Recruiting
  • Erasmus Medisch Centrum-Medical Oncology ( Site 1122)Recruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101Recruiting
  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)Recruiting
  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)Recruiting
  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)Recruiting
  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)Recruiting
  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)Recruiting
  • Clinica Universidad de Navarra-Medical Oncology ( Site 1118)Recruiting
  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)Recruiting
  • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)Recruiting
  • National Taiwan University Hospital-Oncology ( Site 1301)Recruiting
  • Mackay Memorial Hospital ( Site 1305)Recruiting
  • Chang Gung Medical Foundation-Linkou Branch ( Site 1304)Recruiting
  • Istanbul Universitesi Cerrahpasa ( Site 1203)Recruiting
  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)Recruiting
  • Hacettepe Universitesi-oncology hospital ( Site 1209)Recruiting
  • Ankara City Hospital-Medical Oncology ( Site 1202)Recruiting
  • Trakya University-Medical Oncology ( Site 1207)Recruiting
  • Acibadem Universitesi Atakent Hastanesi ( Site 1208)Recruiting
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Pembrolizumab/Vibostolimab Co-Formulation

Pembrolizumab

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

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

Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin

Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel

Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin

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

Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin

Arm Description

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

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.

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.

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 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 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 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 10, 2021
Last Updated
September 27, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05007106
Brief Title
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
February 22, 2027 (Anticipated)
Study Completion Date
February 22, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab/Vibostolimab Co-Formulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
Arm Title
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Vibostolimab Co-Formulation
Other Intervention Name(s)
MK-7684A
Intervention Description
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 200 mg administered via IV infusion Q3W.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvima, E7080, MK-7902
Intervention Description
Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
5-FU, Fluracil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol, cis Platinum
Intervention Description
Cisplatin administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Abraxane, Anzatax
Intervention Description
Paclitaxel administered via IV infusion at investigator's choice of dose
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin administered via IV infusion at investigator's choice of dose and frequency
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin administered via IV infusion Q3W up to 35 cycles
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Description
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.
Time Frame
Up to approximately 2 years
Title
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Description
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.
Time Frame
Up to approximately 2 years
Title
ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors
Description
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.
Time Frame
Up to approximately 2 years
Title
PFS per RECIST 1.1 as Assessed by Investigator at 9 months
Description
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.
Time Frame
9 months
Title
PFS per RECIST 1.1 as Assessed by Investigator at 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 5.5 years
Title
PFS per RECIST 1.1 as Assessed by Investigator
Description
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.
Time Frame
Up to approximately 2 years
Title
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Description
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.
Time Frame
Up to approximately 2 years
Title
DOR per RECIST 1.1 as Assessed by Investigator
Description
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.
Time Frame
Up to approximately 2 years
Title
ORR per RECIST 1.1 as Assessed by Investigator
Description
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.
Time Frame
Up to approximately 2 years
Title
PFS per RECIST 1.1 as Assessed by Investigator in Participants with Cervical Cancer
Description
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.
Time Frame
Up to approximately 2 years
Title
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)
Description
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.
Time Frame
Baseline and up to approximately 2 years
Title
Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)
Description
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.
Time Frame
Baseline and up to approximately 2 years
Title
Number of Participants Who Experienced One or More Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 2 years
Title
Number of Participants Who Discontinued Study Intervention Due to an AE
Description
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.
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors: Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix Endometrial cancer Head and neck squamous cell carcinoma (HNSCC) Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma) Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ). Triple-negative breast cancer (TNBC) Hepatocellular carcinoma (HCC) Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra Ovarian cancer Gastric cancer Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator. Adequately controlled blood pressure (BP) with or without antihypertensive medications. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART). Male participants must agree to follow contraceptive guidance. Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance. Adequate organ function. Exclusion Criteria: History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent. Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication. Active autoimmune disease that has required systemic treatment in past 2 years. Active infection requiring systemic therapy. Concurrent active hepatitis B and hepatitis C virus infection. History of allogenic tissue/solid organ transplant. Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm). Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Womens Cancer Care ( Site 1016)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
907-562-4673
Facility Name
City of Hope Comprehensive Cancer Center ( Site 1001)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-471-9200
Facility Name
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Individual Site Status
Completed
Facility Name
Karmanos Cancer Institute ( Site 1007)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
734-330-6512
Facility Name
Memorial Sloan Kettering - Basking Ridge ( Site 1023)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-679-5955
Facility Name
Memorial Sloan Kettering - Monmouth ( Site 1022)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-679-5955
Facility Name
Memorial Sloan Kettering- Commack ( Site 1021)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-679-5955
Facility Name
Memorial Sloan Kettering - Westchester ( Site 1020)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-679-5955
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 1002)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-679-5955
Facility Name
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
605-376-4905
Facility Name
Houston Methodist Hospital ( Site 1017)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-441-6616
Facility Name
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
613-549-6666 Ext 6641
Facility Name
Princess Margaret Cancer Centre ( Site 1056)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
416-946-4575
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 1404)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56961064692
Facility Name
FALP-UIDO ( Site 1401)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56939263055
Facility Name
Oncovida ( Site 1405)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56961064692
Facility Name
Bradfordhill-Clinical Area ( Site 1402)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56961064692
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 1422)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573126867004
Facility Name
Clinica de la Costa S.A.S. ( Site 1421)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+575 3369999
Facility Name
Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111511
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573125199934
Facility Name
Oncologos del Occidente ( Site 1424)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+57 6 3310712 Ext. 417
Facility Name
Fundación Cardiovascular de Colombia ( Site 1423)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573215433439
Facility Name
Centre Georges François Leclerc ( Site 1155)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
03 45 34 80 68
Facility Name
Institut Régional du Cancer Montpellier ( Site 1157)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33467612304
Facility Name
Gustave Roussy-medicine departement ( Site 1153)
City
Villejuif
State/Province
Paris
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33142114571
Facility Name
CENTRE LEON BERARD-Medical oncology ( Site 1151)
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33478782935
Facility Name
Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33490276397
Facility Name
Institut Curie ( Site 1152)
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33144324086
Facility Name
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4962215636051
Facility Name
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
City
Tübingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4970712982795
Facility Name
Klinikum der Universität München Großhadern ( Site 1176)
City
München
State/Province
Bayern
ZIP/Postal Code
81337
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4989 4400 75250
Facility Name
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+492118117820
Facility Name
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 30 84450
Facility Name
Rambam Health Care Campus-Oncology ( Site 1141)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ 972 4 7776724
Facility Name
Hadassah Medical Center-Oncology ( Site 1142)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ 972 2 6776760
Facility Name
Sheba Medical Center-ONCOLOGY ( Site 1144)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ 972 3 5302243
Facility Name
Sourasky Medical Center-Oncology ( Site 1143)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ 972 3 6973082
Facility Name
Ospedale San Raffaele-Oncologia Medica ( Site 1135)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390226436523
Facility Name
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390257490439
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00393331891929
Facility Name
Aichi Cancer Center Hospital ( Site 1324)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-762-6111
Facility Name
National Cancer Center Hospital East ( Site 1321)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-4-7133-1111
Facility Name
Osaka International Cancer Institute ( Site 1323)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6945-1181
Facility Name
National Cancer Center Hospital ( Site 1322)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3542-2511
Facility Name
Seoul National University Hospital-Internal Medicine ( Site 1312)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-2072-0850
Facility Name
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-2228-8132
Facility Name
Asan Medical Center ( Site 1313)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-3010-0491
Facility Name
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31205122446
Facility Name
Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31107034897
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48 22 546 33 81
Facility Name
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48 695 802 353
Facility Name
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48502204953
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
City
Hospitalet
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
932607294
Facility Name
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 913368263
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34914521987
Facility Name
Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
913531920
Facility Name
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955013068
Facility Name
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-6-2353535
Facility Name
National Taiwan University Hospital-Oncology ( Site 1301)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-2-23123456
Facility Name
Mackay Memorial Hospital ( Site 1305)
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886 2 2543 3535
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-3-3281200
Facility Name
Istanbul Universitesi Cerrahpasa ( Site 1203)
City
Istanbul- Fatih
State/Province
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 2124400000
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903223444445
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 1209)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
90 312 305 29 29
Facility Name
Ankara City Hospital-Medical Oncology ( Site 1202)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0903125526000
Facility Name
Trakya University-Medical Oncology ( Site 1207)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
90 284 235 76 41
Facility Name
Acibadem Universitesi Atakent Hastanesi ( Site 1208)
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324634021
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
90 216 606 52 00

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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

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