Back to resultsEvaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008)
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Pembrolizumab/Quavonlimab
Pembrolizumab/Favezelimab
Pembrolizumab/Vibostolimab
MK-4830
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Eligibility Criteria
Inclusion Criteria:
- Has a histologically confirmed diagnosis of Stage IV CRC adenocarcinoma (as defined by American Joint Committee on Cancer [AJCC] version 8)
- Has locally confirmed dMMR/MSI-H
- Has a life expectancy of at least 3 months
- Female participants are eligible to participate if not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP), or if a WOCBP then uses a contraceptive method that is highly effective or is abstinent on a long-term and persistent basis, during the intervention period and for at least 120 days after the last dose of study intervention
- Has measurable disease per RECIST 1.1 as assessed by the site and verified by BICR
- Submit an archival (within 5 years of Screening) or newly obtained tumor tissue sample that has not been previously irradiated; formalin-fixed, paraffin embedded (FFPE) blocks are preferred to slides.
- Has adequate organ function
Cohort A:
- Has been previously treated for their disease and radiographically progressed per RECIST 1.1 on or after or could not tolerate standard treatment, which must include all of the following agents if approved and locally available in the country where the participant is randomized:
- Fluoropyrimidine, irinotecan and oxaliplatin (capecitabine is acceptable as equivalent to fluorouracil in prior therapy)
- With or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (e.g., bevacizumab)
- At least one of the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for rat sarcoma viral oncogene homolog (RAS) wild-type participants with left-sided tumors. Prior EGFR therapy is optional for patients with right sided RAS Wild-type (WT) tumors.
Cohort B:
- Has untreated Stage IV dMMR/MSI-H CRC with no prior chemotherapy or immunotherapy for this disease
Exclusion Criteria:
- Has received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has not recovered adequately from a surgery procedure, and/or has any complications from a prior surgery before starting study intervention
- Has received prior radiotherapy within 2 weeks of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab, quavonlimab, favezelimab, vibostolimab, MK-4830, and/or any of their excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
- Has a history of acute or chronic pancreatitis
- Has neuromuscular disorders associated with an elevated creatine kinase
- Has urine protein ≥1 gram/24 hours
- Has an active infection requiring systemic therapy (e.g., tuberculosis, known viral or bacterial infections, etc.)
- Has a known history of Human Immunodeficiency Virus (HIV) infection
- Concurrent active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable Hepatitis B Virus [HBV] deoxyribonucleic acid [DNA]) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid [RNA] infection
- Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study intervention administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
- Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before randomization/allocation
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- Mid Florida Cancer Center ( Site 1519)Recruiting
- University Cancer & Blood Center, LLC ( Site 1521)Recruiting
- University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal PRecruiting
- Icahn School of Medicine at Mount Sinai ( Site 1528)Recruiting
- Hematology Oncology Associates of Rockland ( Site 1525)Recruiting
- UPMC Hillman Cancer Center ( Site 1516)
- Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)Recruiting
- UT Southwestern Medical Center ( Site 1551)Recruiting
- Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
- Northwest Medical Specialties, PLLC ( Site 1546)Recruiting
- UZ Brussel ( Site 0105)Recruiting
- Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)Recruiting
- Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)Recruiting
- UZ Leuven ( Site 0101)Recruiting
- AZ Delta vzw ( Site 0106)Recruiting
- The Moncton Hospital-Oncology ( Site 0307)Recruiting
- McGill University Health Centre-CIM - Oncology ( Site 0306)Recruiting
- Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)Recruiting
- Clinica de la Costa S.A.S. ( Site 1608)Recruiting
- Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601)Recruiting
- Oncomédica S.A.S ( Site 1602)Recruiting
- Mediservis del Tolima IPS S.A.S ( Site 1609)Recruiting
- CIMCA-Hemato-Oncology ( Site 2101)Recruiting
- Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)Recruiting
- Rigshospitalet ( Site 1904)Recruiting
- Regionshospitalet Gødstrup ( Site 1901)Recruiting
- Aalborg Universitetshospital, Syd ( Site 1903)Recruiting
- Odense Universitetshospital ( Site 1902)Recruiting
- North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)Recruiting
- Tartu University Hospital ( Site 2302)Recruiting
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et
- Centre Georges François Leclerc ( Site 0506)Recruiting
- CHU Rangueil-Digestive oncology department ( Site 0502)
- Hopital Claude Huriez - CHU de Lille ( Site 0510)
- Centre Hospitalier Universitaire de Poitiers ( Site 0511)
- Hôpital Saint Antoine-Oncologie médicale ( Site 0508)
- Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612)Recruiting
- Universitätsklinikum Marburg ( Site 0610)Recruiting
- Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611)Recruiting
- Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und InfektiologieRecruiting
- Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)Recruiting
- Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)Recruiting
- Asklepios Altona-Oncology ( Site 0602)Recruiting
- Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704)Recruiting
- Evgenidion Hospital ( Site 2702)Recruiting
- University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703)Recruiting
- European Interbalkan Medical Center-Oncology Department ( Site 2701)Recruiting
- CELAN,S.A ( Site 2202)Recruiting
- INTEGRA Cancer Institute-Oncology ( Site 2201)Recruiting
- MEDI-K CAYALA ( Site 2205)Recruiting
- Centro Regional de Sub Especialidades Médicas SA ( Site 2204)Recruiting
- Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)Recruiting
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)Recruiting
- Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001)Recruiting
- Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010)Recruiting
- Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)Recruiting
- Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)Recruiting
- Istituto Oncologico Veneto IRCCS ( Site 0804)Recruiting
- Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)Recruiting
- Korea University Anam Hospital ( Site 1107)Recruiting
- Seoul National University Hospital-Internal Medicine ( Site 1101)Recruiting
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)Recruiting
- Asan Medical Center-Department of Oncology ( Site 1105)Recruiting
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)Recruiting
- The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)Recruiting
- Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402)Recruiting
- National Cancer Institute ( Site 2401)Recruiting
- VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)Recruiting
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901)Recruiting
- DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)Recruiting
- Powiatowe Centrum Zdrowia ( Site 0911)Recruiting
- Luxmed Onkologia sp. z o. o. ( Site 0915)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( SiteRecruiting
- Mrukmed-Mrukmed ( Site 0901)Recruiting
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)Recruiting
- Fundeni Clinical Institute-Medical Oncology ( Site 2603)Recruiting
- Centrul medical Focus ( Site 2601)Recruiting
- Cardiomed SRL Cluj-Napoca ( Site 2602)Recruiting
- Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604)Recruiting
- Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)
- Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy
- First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl
- Rostov Cancer Research Institute ( Site 1014)
- GBUZ SPb CRPCstmc(o) ( Site 1005)
- Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)
- Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)Recruiting
- Hospital Universitario Marqués de Valdecilla ( Site 1202)Recruiting
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)Recruiting
- H.R.U Málaga - Hospital General ( Site 1207)Recruiting
- Fundación Instituto Valenciano de Oncología ( Site 1209)Recruiting
- Hospital Universitari Vall d'Hebron ( Site 1201)Recruiting
- Hospital Clinico San Carlos-Oncology Department ( Site 1204)Recruiting
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303)Recruiting
- Hacettepe Universitesi-oncology hospital ( Site 1301)Recruiting
- Ankara City Hospital-Medical Oncology ( Site 1306)Recruiting
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)Recruiting
- Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401)Recruiting
- UCLH-Cancer Clinical Trials Unit ( Site 1402)Recruiting
- Velindre Cancer Centre-Research and Development ( Site 1415)Recruiting
- University Hospital Coventry & Warwickshire ( Site 1406)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Pembrolizumab
Pembrolizumab/Quavonlimab
Pembrolizumab/Favezelimab
Pembrolizumab/Vibostolimab
Pembrolizumab Plus MK-4830
Arm Description
Participants receive pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for up to approximately 2 years.
Participants receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (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. ORR as assessed by BICR will be presented.
Secondary Outcome Measures
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
DOR is defined as the time from the first documented evidence of 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 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
PFS per RECIST 1.1 as assessed by Investigator
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS 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. ORR as assessed by investigator will be presented.
DOR per RECIST 1.1 as assessed by Investigator
DOR is defined as the time from the first documented evidence of 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 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.
Overall Survival (OS)
OS is defined as the time from randomization (or first dose) to death due to any cause. OS will be presented.
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants with an AE will be presented.
Number of Participants Discontinuing Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants that discontinue study treatment due to an AE will be presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04895722
Brief Title
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008)
Official Title
A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
September 28, 2025 (Anticipated)
Study Completion Date
October 28, 2025 (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
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants receive pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for up to approximately 2 years.
Arm Title
Pembrolizumab/Quavonlimab
Arm Type
Experimental
Arm Description
Participants receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
Arm Title
Pembrolizumab/Favezelimab
Arm Type
Experimental
Arm Description
Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
Arm Title
Pembrolizumab/Vibostolimab
Arm Type
Experimental
Arm Description
Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
Arm Title
Pembrolizumab Plus MK-4830
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda®
Intervention Description
400 mg or 200 mg pembrolizumab administered via IV infusion.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Quavonlimab
Other Intervention Name(s)
MK-1308A
Intervention Description
Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Favezelimab
Other Intervention Name(s)
MK-4280A
Intervention Description
Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Vibostolimab
Other Intervention Name(s)
MK-7684A
Intervention Description
Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion
Intervention Type
Biological
Intervention Name(s)
MK-4830
Intervention Description
800 mg MK-4830 administered via IV infusion
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (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. ORR as assessed by BICR will be presented.
Time Frame
Up to approximately 50 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Description
DOR is defined as the time from the first documented evidence of 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 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time Frame
Up to approximately 50 months
Title
Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR
Description
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. 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 demonstrate an absolute increase of at least 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 50 months
Title
PFS per RECIST 1.1 as assessed by Investigator
Description
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. 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 demonstrate an absolute increase of at least 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 50 months
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. ORR as assessed by investigator will be presented.
Time Frame
Up to approximately 50 months
Title
DOR per RECIST 1.1 as assessed by Investigator
Description
DOR is defined as the time from the first documented evidence of 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 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.
Time Frame
Up to approximately 50 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization (or first dose) to death due to any cause. OS will be presented.
Time Frame
Up to approximately 50 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants with an AE will be presented.
Time Frame
Up to approximately 50 months
Title
Number of Participants Discontinuing Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants that discontinue study treatment due to an AE will be presented.
Time Frame
Up to approximately 50 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a histologically confirmed diagnosis of Stage IV CRC adenocarcinoma (as defined by American Joint Committee on Cancer [AJCC] version 8)
Has locally confirmed dMMR/MSI-H
Has a life expectancy of at least 3 months
Female participants are eligible to participate if not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP), or if a WOCBP then uses a contraceptive method that is highly effective or is abstinent on a long-term and persistent basis, during the intervention period and for at least 120 days after the last dose of study intervention
Has measurable disease per RECIST 1.1 as assessed by the site and verified by BICR
Submit an archival (within 5 years of Screening) or newly obtained tumor tissue sample that has not been previously irradiated; formalin-fixed, paraffin embedded (FFPE) blocks are preferred to slides.
Has adequate organ function
Cohort A:
- Has been previously treated for their disease and radiographically progressed per RECIST 1.1 on or after or could not tolerate standard treatment, which must include all of the following agents if approved and locally available in the country where the participant is randomized:
Fluoropyrimidine, irinotecan and oxaliplatin (capecitabine is acceptable as equivalent to fluorouracil in prior therapy)
With or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (e.g., bevacizumab)
At least one of the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for rat sarcoma viral oncogene homolog (RAS) wild-type participants with left-sided tumors. Prior EGFR therapy is optional for patients with right sided RAS Wild-type (WT) tumors.
Cohort B:
- Has untreated Stage IV dMMR/MSI-H CRC with no prior chemotherapy or immunotherapy for this disease
Exclusion Criteria:
Has received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
Has not recovered adequately from a surgery procedure, and/or has any complications from a prior surgery before starting study intervention
Has received prior radiotherapy within 2 weeks of start of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, quavonlimab, favezelimab, vibostolimab, MK-4830, and/or any of their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
Has a history of acute or chronic pancreatitis
Has neuromuscular disorders associated with an elevated creatine kinase
Has urine protein ≥1 gram/24 hours
Has an active infection requiring systemic therapy (e.g., tuberculosis, known viral or bacterial infections, etc.)
Has a known history of Human Immunodeficiency Virus (HIV) infection
Concurrent active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable Hepatitis B Virus [HBV] deoxyribonucleic acid [DNA]) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid [RNA] infection
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study intervention administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before randomization/allocation
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has had an allogenic tissue/solid organ transplant
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
Mid Florida Cancer Center ( Site 1519)
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-353-1915
Facility Name
University Cancer & Blood Center, LLC ( Site 1521)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
706-353-5006
Facility Name
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
855-702-8222
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 1528)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
347-714-1653
Facility Name
Hematology Oncology Associates of Rockland ( Site 1525)
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
845-480-7440
Facility Name
UPMC Hillman Cancer Center ( Site 1516)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-811-8480
Facility Name
UT Southwestern Medical Center ( Site 1551)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-645-4673
Facility Name
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Medical Specialties, PLLC ( Site 1546)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
253-428-8700
Facility Name
UZ Brussel ( Site 0105)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
024749917
Facility Name
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003227641041
Facility Name
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3281423857
Facility Name
UZ Leuven ( Site 0101)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003216344218
Facility Name
AZ Delta vzw ( Site 0106)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3251237215
Facility Name
The Moncton Hospital-Oncology ( Site 0307)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
506-857-5669
Facility Name
McGill University Health Centre-CIM - Oncology ( Site 0306)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-934-1934x35161
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)
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
573147362301
Facility Name
Clinica de la Costa S.A.S. ( Site 1608)
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
57 5 3369999
Facility Name
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
57 3157411877
Facility Name
Oncomédica S.A.S ( Site 1602)
City
Montería
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
57 3157962122
Facility Name
Mediservis del Tolima IPS S.A.S ( Site 1609)
City
Ibague
State/Province
Tolima
ZIP/Postal Code
730006
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+576082809432
Facility Name
CIMCA-Hemato-Oncology ( Site 2101)
City
San José
State/Province
San Jose
ZIP/Postal Code
1000
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50683893636
Facility Name
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)
City
Santa Ana
State/Province
San Jose
ZIP/Postal Code
10903
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50684978912
Facility Name
Rigshospitalet ( Site 1904)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+45 35455909
Facility Name
Regionshospitalet Gødstrup ( Site 1901)
City
Herning
State/Province
Midtjylland
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4591117070
Facility Name
Aalborg Universitetshospital, Syd ( Site 1903)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4597666795
Facility Name
Odense Universitetshospital ( Site 1902)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4565411590
Facility Name
North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3726171245
Facility Name
Tartu University Hospital ( Site 2302)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3727319568
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Individual Site Status
Completed
Facility Name
Centre Georges François Leclerc ( Site 0506)
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
+33380737500
Facility Name
CHU Rangueil-Digestive oncology department ( Site 0502)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Completed
Facility Name
Hopital Claude Huriez - CHU de Lille ( Site 0510)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Completed
Facility Name
Centre Hospitalier Universitaire de Poitiers ( Site 0511)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Saint Antoine-Oncologie médicale ( Site 0508)
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81737
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
498967942651
Facility Name
Universitätsklinikum Marburg ( Site 0610)
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35033
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 6421 5869034
Facility Name
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4920117424524
Facility Name
Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493916713100
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 351 458 7683
Facility Name
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4930450613132
Facility Name
Asklepios Altona-Oncology ( Site 0602)
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0049 30 45050
Facility Name
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00306946462998
Facility Name
Evgenidion Hospital ( Site 2702)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306944290909
Facility Name
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703)
City
Heraklion
State/Province
Irakleio
ZIP/Postal Code
715 00
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
302810392750
Facility Name
European Interbalkan Medical Center-Oncology Department ( Site 2701)
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302310400368
Facility Name
CELAN,S.A ( Site 2202)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50242142081
Facility Name
INTEGRA Cancer Institute-Oncology ( Site 2201)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50254530410
Facility Name
MEDI-K CAYALA ( Site 2205)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50255505555
Facility Name
Centro Regional de Sub Especialidades Médicas SA ( Site 2204)
City
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259450559
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259458053
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3676516719
Facility Name
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36209323256
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010)
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36303960374
Facility Name
Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36202051965
Facility Name
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3652255840
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223903835
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3908159031775
Facility Name
Istituto Oncologico Veneto IRCCS ( Site 0804)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390498215910
Facility Name
Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
053-200-3017
Facility Name
Korea University Anam Hospital ( Site 1107)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8229206090
Facility Name
Seoul National University Hospital-Internal Medicine ( Site 1101)
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
+82220720795
Facility Name
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)
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) 331 2471
Facility Name
Asan Medical Center-Department of Oncology ( Site 1105)
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) 331 2471
Facility Name
Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02-2148-7394
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82 (2) 331 2471
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402)
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37060105626
Facility Name
National Cancer Institute ( Site 2401)
City
Vilnius
State/Province
Vilniaus Miestas
ZIP/Postal Code
08660
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37064766126
Facility Name
VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)
City
Vilnius
ZIP/Postal Code
08460
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37068388052
Facility Name
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901)
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
31205122047
Facility Name
DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-413
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48605363024
Facility Name
Powiatowe Centrum Zdrowia ( Site 0911)
City
Brzeziny
State/Province
Lodzkie
ZIP/Postal Code
95-060
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48426895477
Facility Name
Luxmed Onkologia sp. z o. o. ( Site 0915)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48691666578
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-034
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
225709223
Facility Name
Mrukmed-Mrukmed ( Site 0901)
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-021
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48178502470
Facility Name
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)
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
943488930
Facility Name
Fundeni Clinical Institute-Medical Oncology ( Site 2603)
City
București
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722300252
Facility Name
Centrul medical Focus ( Site 2601)
City
București
State/Province
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40721298677
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 2602)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040724543672
Facility Name
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722161545
Facility Name
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Rostov Cancer Research Institute ( Site 1014)
City
Rostov on Don
State/Province
Rostovskaya Oblast
ZIP/Postal Code
344037
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
GBUZ SPb CRPCstmc(o) ( Site 1005)
City
Sankt- Peterburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34985106100Ext36281
Facility Name
Hospital Universitario Marqués de Valdecilla ( Site 1202)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34942202525
Facility Name
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914269394
Facility Name
H.R.U Málaga - Hospital General ( Site 1207)
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34951308129
Facility Name
Fundación Instituto Valenciano de Oncología ( Site 1209)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34961245877
Facility Name
Hospital Universitari Vall d'Hebron ( Site 1201)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934894350
Facility Name
Hospital Clinico San Carlos-Oncology Department ( Site 1204)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913303000
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325005269
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 1301)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903123051080
Facility Name
Ankara City Hospital-Medical Oncology ( Site 1306)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905555306271
Facility Name
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902124143000
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90216 606 52 00
Facility Name
Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
g12OYN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01413017121
Facility Name
UCLH-Cancer Clinical Trials Unit ( Site 1402)
City
London-Camden
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07908714339
Facility Name
Velindre Cancer Centre-Research and Development ( Site 1415)
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07988704574
Facility Name
University Hospital Coventry & Warwickshire ( Site 1406)
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02476967151
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
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1308A-008&&kw=1308A-008
Description
Plain Language Summary
Learn more about this trial
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008)
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