Last updated 16 days ago
Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
730 patients around the world
Available in Chile, United States, Spain
Merck Sharp & Dohme Corp.
7Research sites
730Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosis of one of the following advanced (unresectable and/or metastatic) solid tumors, documented by histopathology or cytopathology: Hepatocellular carcinoma (HCC), Colorectal cancer (CRC) (non-microsatellite instability-high [non-MSI-H]/deficient mismatch repair [dMMR]), Pancreatic ductal adenocarcinoma (PDAC), Biliary tract cancer (BTC) (includes intrahepatic, extrahepatic cholangiocarcinoma [CCA] and gall bladder cancer), Endometrial cancer (EC), Esophageal squamous cell carcinoma (ESCC)Diagnosis of one of the following advanced (unresectable and/or metastatic) solid tumors, documented by histopathology or cytopathology:Hepatocellular carcinoma (HCC)Colorectal cancer (CRC) (non-microsatellite instability-high [non-MSI-H]/deficient mismatch repair [dMMR])Pancreatic ductal adenocarcinoma (PDAC).Biliary tract cancer (BTC) (includes intrahepatic, extrahepatic cholangiocarcinoma [CCA] and gall bladder cancer)Endometrial cancer (EC)Esophageal squamous cell carcinoma (ESCC)Disease progression on or since the most recent treatment (does not apply to newly diagnosed unresectable or metastatic HCC or EC).Measurable disease per RECIST v1.1 as assessed locally (by investigator) and verified by BICRSubmission of an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiatedMale participants are abstinent from heterosexual intercourse or agree to follow contraceptive guidance during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinibFemale participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and and for at least 120 days after the last dose of pembrolizumab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs lastAdequate organ functionAdequately controlled blood pressure with or without antihypertensive medicationsHCC Specific Inclusion Criteria: No prior systemic chemotherapy, including anti-VEGF therapy, anti-programmed cell-death (PD-1)/PD-L1 or any systemic investigational anticancer agents for advanced/unresectable HCC (1L)CRC ([non-MSI-H/dMMR) Specific Inclusion Criteria: Received at least 2 prior lines of systemic therapy for unresectable or metastatic disease which includes fluoropyrimidine, irinotecan and oxaliplatinPDAC Specific Inclusion Criteria: Prior therapy with at least 1 (platinum or gemcitabine containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancerBTC Specific Inclusion Criteria: Received at least 1 prior line of systemic therapy (containing gemcitabine or fluoropyrimidine) for unresectable or metastatic diseaseEC Specific Inclusion Criteria: Study treatment is for 1L therapy of EC and participants should not have received prior systemic chemotherapy. Exception: May have received 1 prior line of line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of a curative-intent resection, if the recurrence occurred ≥6 months after the last dose of chemotherapy or may have received prior radiation with or without chemotherapyESCC Specific Inclusion Criteria: Have experienced radiographic or clinical progression on one prior line of standard systemic therapy (immune oncology (IO) naïve participants) or an anti-PD-1/PD-L1 (IO resistant participants)
- Unable to swallow orally administered medication or presence of a gastrointestinal (GI) disorder that may affect study intervention absorptionHistory of a second malignancy that is progressing or has required active treatment within 3 yearsA pulse oximeter reading <92% at rest, or requirement of intermittent supplemental oxygen/chronic supplemental oxygenA pulse oximeter reading <92% at rest, or requirement of intermittent supplemental oxygen/ chronic supplemental oxygenPresence of central nervous system (CNS) metastases and/or carcinomatous meningitisClinically significant cardiovascular disease within 6 months of first dose of study interventionSymptomatic pleural effusion, unless clinically stable after treatmentPreexisting ≥ Grade 3 gastrointestinal (GI) or non-GI fistulaModerate to severe hepatic impairmentClinically significant history of bleeding within 3 months before screeningPresence of serious active nonhealing wound/ulcer/bone fractureRequirement for hemodialysis or peritoneal dialysisHistory of human immunodeficiency virus (HIV) infectionHistory of Hepatitis B or active Hepatis C virus infections. with exceptions for HCC and BTCPrior therapy with a PD-1, anti-PD-L1, anti-PD-L2 agent, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) or hypoxia-inducible factor 2α (HIF-2α)Radiographic evidence of intratumoral cavitation, or invasion/infiltration of a major blood vesselEC specific exclusion criteria: History of carcinosarcoma, endometrial leiomyosarcoma or other high-grade sarcomas, or endometrial stromal sarcomasESCC specific exclusion criteria: Has clinically apparent ascites or pleural effusion or experienced weight loss >20% over approximately 3 months before first dose of study therapy
Sites
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Clínica Puerto Montt
Recruiting
Oncovida - Santiago
Recruiting
James Lind Centro de Investigación del Cáncer - Temuco
Recruiting
Hospital Universitario Central de Asturias
Recruiting
Hospital General Universitario Gregorio Marañón
Recruiting
Hospital Vall de Hebrón
Recruiting
SponsorMerck Sharp & Dohme Corp.
Study typeInterventional
Conditions
Solid tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04976634
