Hepatocellular Carcinoma Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 610 |
Est. completion date | February 22, 2027 |
Est. primary completion date | February 22, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051) | Kingston | Ontario |
Canada | Princess Margaret Cancer Centre ( Site 1056) | Toronto | Ontario |
Chile | Bradfordhill-Clinical Area ( Site 1402) | Santiago | Region M. De Santiago |
Chile | FALP-UIDO ( Site 1401) | Santiago | Region M. De Santiago |
Chile | Oncovida ( Site 1405) | Santiago | Region M. De Santiago |
Chile | James Lind Centro de Investigación del Cáncer ( Site 1404) | Temuco | Araucania |
Colombia | Clinica de la Costa S.A.S. ( Site 1421) | Barranquilla | Atlantico |
Colombia | Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425) | Bogotá | Cundinamarca |
Colombia | Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422) | Medellin | Antioquia |
Colombia | Oncologos del Occidente ( Site 1424) | Pereira | Risaralda |
Colombia | Fundación Cardiovascular de Colombia ( Site 1423) | Piedecuesta | Santander |
France | Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156) | Avignon | Vaucluse |
France | Centre Georges François Leclerc ( Site 1155) | Dijon | Cote-d Or |
France | CENTRE LEON BERARD-Medical oncology ( Site 1151) | Lyon | Rhone-Alpes |
France | Institut Régional du Cancer Montpellier ( Site 1157) | Montpellier | Herault |
France | Institut Curie ( Site 1152) | Paris | |
France | Gustave Roussy-medicine departement ( Site 1153) | Villejuif | Paris |
Germany | Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171) | Berlin | |
Germany | Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172) | Düsseldorf | Nordrhein-Westfalen |
Germany | Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180) | Heidelberg | Baden-Wurttemberg |
Germany | Klinikum der Universität München Großhadern ( Site 1176) | München | Bayern |
Germany | Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne | Tübingen | Baden-Wurttemberg |
Israel | Rambam Health Care Campus-Oncology ( Site 1141) | Haifa | |
Israel | Hadassah Medical Center-Oncology ( Site 1142) | Jerusalem | |
Israel | Sheba Medical Center-ONCOLOGY ( Site 1144) | Ramat Gan | |
Israel | Sourasky Medical Center-Oncology ( Site 1143) | Tel Aviv | |
Italy | Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( | Milano | |
Italy | Ospedale San Raffaele-Oncologia Medica ( Site 1135) | Milano | Lombardia |
Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134) | Napoli | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136) | Roma | Lazio |
Japan | National Cancer Center Hospital East ( Site 1321) | Kashiwa | Chiba |
Japan | Aichi Cancer Center Hospital ( Site 1324) | Nagoya | Aichi |
Japan | Osaka International Cancer Institute ( Site 1323) | Osaka | |
Japan | National Cancer Center Hospital ( Site 1322) | Tokyo | |
Korea, Republic of | Asan Medical Center ( Site 1313) | Seoul | |
Korea, Republic of | Seoul National University Hospital-Internal Medicine ( Site 1312) | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311) | Seoul | |
Netherlands | Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121) | Amsterdam | Noord-Holland |
Netherlands | Erasmus Medisch Centrum-Medical Oncology ( Site 1122) | Rotterdam | Zuid-Holland |
Poland | Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103) | Gdansk | Pomorskie |
Poland | Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104) | Koszalin | Zachodniopomorskie |
Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101 | Warszawa | Mazowieckie |
Spain | Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113) | Hospitalet | Barcelona |
Spain | Clinica Universidad de Navarra-Medical Oncology ( Site 1118) | Madrid | |
Spain | Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111) | Madrid | Madrid, Comunidad De |
Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117) | Pozuelo de Alarcon | Madrid |
Spain | HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114) | Sevilla | |
Taiwan | NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302) | Tainan | |
Taiwan | Mackay Memorial Hospital ( Site 1305) | Taipei | |
Taiwan | National Taiwan University Hospital-Oncology ( Site 1301) | Taipei | |
Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 1304) | Taoyuan | |
Turkey | Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201) | Adana | |
Turkey | Ankara City Hospital-Medical Oncology ( Site 1202) | Ankara | |
Turkey | Hacettepe Universitesi-oncology hospital ( Site 1209) | Ankara | |
Turkey | Trakya University-Medical Oncology ( Site 1207) | Edirne | |
Turkey | Acibadem Universitesi Atakent Hastanesi ( Site 1208) | Istanbul | |
Turkey | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204) | Istanbul | |
Turkey | Istanbul Universitesi Cerrahpasa ( Site 1203) | Istanbul- Fatih | Istanbul |
United States | Alaska Womens Cancer Care ( Site 1016) | Anchorage | Alaska |
United States | Memorial Sloan Kettering - Basking Ridge ( Site 1023) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering- Commack ( Site 1021) | Commack | New York |
United States | Karmanos Cancer Institute ( Site 1007) | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center ( Site 1001) | Duarte | California |
United States | Memorial Sloan Kettering - Westchester ( Site 1020) | Harrison | New York |
United States | Houston Methodist Hospital ( Site 1017) | Houston | Texas |
United States | Memorial Sloan Kettering - Monmouth ( Site 1022) | Middletown | New Jersey |
United States | Memorial Sloan Kettering - Bergen ( Site 1025) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center ( Site 1002) | New York | New York |
United States | University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente | Orange | California |
United States | Sanford Cancer Center-Gynecologic Oncology ( Site 1015) | Sioux Falls | South Dakota |
United States | Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024) | Tulsa | Oklahoma |
United States | Memorial Sloan Kettering - Nassau ( Site 1026) | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme LLC |
United States, Canada, Chile, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to approximately 2 years | |
Primary | Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. | Up to approximately 2 years | |
Primary | ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors | ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented. | Up to approximately 2 years | |
Primary | PFS per RECIST 1.1 as Assessed by Investigator at 9 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. | 9 months | |
Primary | PFS per RECIST 1.1 as Assessed by Investigator at 12 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. | 12 months | |
Secondary | Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 5.5 years | |
Secondary | 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. | Up to approximately 2 years | |
Secondary | 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. | Up to approximately 2 years | |
Secondary | 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. | Up to approximately 2 years | |
Secondary | 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. | Up to approximately 2 years | |
Secondary | 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. | Up to approximately 2 years | |
Secondary | 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. | Baseline and up to approximately 2 years | |
Secondary | 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. | Baseline and up to approximately 2 years | |
Secondary | 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. | Up to approximately 2 years | |
Secondary | 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. | Up to approximately 2 years |
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