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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05007106
Collaborator
(none)
610
64
9
41.1
9.5
0.2

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
610 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 16, 2021
Anticipated Primary Completion Date :
Feb 19, 2025
Anticipated Study Completion Date :
Feb 19, 2025

Arms and Interventions

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:
  • Lenvima
  • E7080
  • 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:
  • Lenvima
  • E7080
  • 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 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

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) [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.

    2. Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR [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.

    3. ORR per RECIST 1.1 as Assessed by Investigator [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.

    4. PFS per RECIST 1.1 as Assessed by Investigator at 9 months [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.

    5. PFS per RECIST 1.1 as Assessed by Investigator at 12 months [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

    1. Overall Survival (OS) [Up to approximately 3 years]

      OS is defined as the time from randomization to death due to any cause.

    2. PFS per RECIST 1.1 as Assessed by Investigator [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.

    3. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR [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.

    4. DOR per RECIST 1.1 as Assessed by Investigator [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.

    5. ORR per RECIST 1.1 as Assessed by Investigator [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.

    6. 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) [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.

    7. Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5) [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.

    8. Number of Participants Who Experienced One or More Adverse Events (AEs) [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.

    9. Number of Participants Who Discontinued Study Intervention Due to an AE [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Womens Cancer Care ( Site 1016) Anchorage Alaska United States 99508
    2 City of Hope Comprehensive Cancer Center ( Site 1001) Duarte California United States 91010
    3 University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente Orange California United States 92868
    4 Karmanos Cancer Institute ( Site 1007) Detroit Michigan United States 48201
    5 Memorial Sloan Kettering - Monmouth ( Site 1022) Middletown New Jersey United States 07748
    6 Memorial Sloan Kettering- Commack ( Site 1021) Commack New York United States 11725
    7 Memorial Sloan Kettering - Westchester ( Site 1020) Harrison New York United States 10604
    8 Memorial Sloan Kettering Cancer Center ( Site 1002) New York New York United States 10065
    9 Sanford Cancer Center-Gynecologic Oncology ( Site 1015) Sioux Falls South Dakota United States 57104
    10 Houston Methodist Hospital ( Site 1017) Houston Texas United States 77030
    11 Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051) Kingston Ontario Canada K7L 2V7
    12 Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1056) Toronto Ontario Canada M5G 2M9
    13 James Lind Centro de Investigación del Cáncer ( Site 1404) Temuco Araucania Chile 4780000
    14 FALP-UIDO ( Site 1401) Santiago Region M. De Santiago Chile 6900941
    15 Oncovida ( Site 1405) Santiago Region M. De Santiago Chile 7510032
    16 Bradfordhill-Clinical Area ( Site 1402) Santiago Region M. De Santiago Chile 8420383
    17 Clínica Vida Fundación - Sede Poblado ( Site 1422) Medellin Antioquia Colombia 050030
    18 Clinica de la Costa LTDA ( Site 1421) Barranquilla Atlantico Colombia 080020
    19 Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425) Bogotá Cundinamarca Colombia 111511
    20 Oncologos del Occidente ( Site 1424) Pereira Risaralda Colombia 660001
    21 Fundación Cardiovascular de Colombia ( Site 1423) Piedecuesta Santander Colombia 681017
    22 Centre Georges François Leclerc ( Site 1155) Dijon Cote-d Or France 21079
    23 Institut Régional du Cancer Montpellier ( Site 1157) Montpellier Herault France 34298
    24 Gustave Roussy-medicine departement ( Site 1153) Villejuif Paris France 94800
    25 CENTRE LEON BERARD-Medical oncology ( Site 1151) Lyon Rhone-Alpes France 69008
    26 Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156) Avignon Vaucluse France 84918
    27 Institut Curie ( Site 1152) Paris France 75005
    28 Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180) Heidelberg Baden-Wurttemberg Germany 69120
    29 Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne Tübingen Baden-Wurttemberg Germany 72076
    30 Klinikum der Universität München Großhadern ( Site 1176) München Bayern Germany 81337
    31 Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172) Düsseldorf Nordrhein-Westfalen Germany 40225
    32 Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171) Berlin Germany 12203
    33 Rambam Health Care Campus-Oncology ( Site 1141) Haifa Israel 3109601
    34 Hadassah Medical Center-Oncology ( Site 1142) Jerusalem Israel 9112001
    35 Sheba Medical Center-ONCOLOGY ( Site 1144) Ramat Gan Israel 5262100
    36 Sourasky Medical Center-Oncology ( Site 1143) Tel Aviv Israel 6423906
    37 Ospedale San Raffaele-Oncologia Medica ( Site 1135) Milano Italy 20132
    38 Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Milano Italy 20141
    39 Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134) Napoli Italy 80131
    40 National Cancer Center Hospital East ( Site 1321) Kashiwa Chiba Japan 277-8577
    41 National Cancer Center Hospital ( Site 1322) Tokyo Japan 104-0045
    42 Seoul National University Hospital-Internal Medicine ( Site 1312) Seoul Korea, Republic of 03080
    43 Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311) Seoul Korea, Republic of 03722
    44 Asan Medical Center ( Site 1313) Seoul Korea, Republic of 05505
    45 Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121) Amsterdam Noord-Holland Netherlands 1066 CX
    46 Erasmus Medisch Centrum-Medical Oncology ( Site 1122) Rotterdam Zuid-Holland Netherlands 3015 GD
    47 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101 Warszawa Mazowieckie Poland 02-781
    48 Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103) Gdańsk Pomorskie Poland 80-952
    49 Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104) Koszalin Zachodniopomorskie Poland 75-581
    50 Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113) Hospitalet Barcelona Spain 08907
    51 Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111) Madrid Madrid, Comunidad De Spain 28034
    52 HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117) Pozuelo de Alarcon Madrid Spain 28223
    53 HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114) Sevilla Spain 41013
    54 NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302) Tainan Taiwan 704
    55 National Taiwan University Hospital-Oncology ( Site 1301) Taipei Taiwan 10002
    56 Mackay Memorial Hospital ( Site 1305) Taipei Taiwan
    57 Chang Gung Medical Foundation-Linkou Branch ( Site 1304) Taoyuan Taiwan 333
    58 Istanbul Universitesi Cerrahpasa ( Site 1203) Istanbul- Fatih Istanbul Turkey 34098
    59 Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201) Adana Turkey 01250
    60 Hacettepe Universitesi-oncology hospital ( Site 1209) Ankara Turkey 06230
    61 Ankara City Hospital-Medical Oncology ( Site 1202) Ankara Turkey 06800
    62 Trakya University-Medical Oncology ( Site 1207) Edirne Turkey 22030
    63 Acibadem Universitesi Atakent Hastanesi ( Site 1208) Istanbul Turkey 34303
    64 TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204) Istanbul Turkey 34722

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT05007106
    Other Study ID Numbers:
    • 7684A-005
    • MK-7684A-005
    • jRCT2031210335
    • KEYVIBE-005
    • 2021-001009-56
    First Posted:
    Aug 16, 2021
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022

    Study Results

    No Results Posted as of Jul 25, 2022