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An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503905-12-00
Acronym
MK-6482-016
Enrollment
104
Registered
2023-10-30
Start date
2021-08-20
Completion date
Unknown
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cancer; Colon cancer; Pancreatic cancer; Bile Duct or Gallbladder cancer; Endometrial cancer; Esophageal cancer

Brief summary

Number of Participants in Lead-in Phase Who Experience at Least One Dose-limiting Toxicity (DLT), Number of Participants in Arm 1/Triplet Who Experience at Least One Adverse Event (AE), Number of Participants in Arm 1/Triplet Who Discontinue Study Treatment Due to an AE, Objective Response Rate Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Detailed description

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR, Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR, Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR, Overall Survival (OS), ORR Per Modified Response Criteria in Solid Tumors Version 1.1 (mRECIST 1.1) for Hepatocellular Carcinoma (HCC) as Assessed by BICR, DOR Per mRECIST 1.1 for HCC as Assessed by BICR, DCR Per mRECIST 1.1 for HCC as Assessed by BICR, PFS Per mRECIST 1.1 for HCC as Assessed by BICR, Number of Participants in Arm 2/Doublet Who Experience at Least One AE, Number of Participants in Arm 2/Doublet Who Discontinue Study Treatment Due to an AE

Interventions

DRUGLenvatinib
DRUGBelzutifan
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants in Lead-in Phase Who Experience at Least One Dose-limiting Toxicity (DLT), Number of Participants in Arm 1/Triplet Who Experience at Least One Adverse Event (AE), Number of Participants in Arm 1/Triplet Who Discontinue Study Treatment Due to an AE, Objective Response Rate Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)—

Secondary

MeasureTime frame
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR, Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR, Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR, Overall Survival (OS), ORR Per Modified Response Criteria in Solid Tumors Version 1.1 (mRECIST 1.1) for Hepatocellular Carcinoma (HCC) as Assessed by BICR, DOR Per mRECIST 1.1 for HCC as Assessed by BICR, DCR Per mRECIST 1.1 for HCC as Assessed by BICR, PFS Per mRECIST 1.1 for HCC as Assessed by BICR, Number of Participants in Arm 2/Doublet Who Experience at Least One AE, Number of Participants in Arm 2/Doublet Who Discontinue Study Treatment Due to an AE—

Countries

Belgium, France, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026