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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05007106
Other study ID # 7684A-005
Secondary ID MK-7684A-005jRCT
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 16, 2021
Est. completion date February 22, 2027

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Drug:
Lenvatinib
Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
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
Cisplatin
Cisplatin administered via IV infusion
Paclitaxel
Paclitaxel administered via IV infusion at investigator's choice of dose
Gemcitabine
Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
Carboplatin
Carboplatin administered via IV infusion at investigator's choice of dose and frequency
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
Bevacizumab
Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
Capecitabine
Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
Oxaliplatin
Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Colombia,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan,  Turkey, 

Outcome

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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