A Phase 2, Multicenter, Clinical Study to Evaluate the Safety and Efficacy of MK-1308A (Coformulated MK-1308/MK-3475) in Combination with Lenvatinib (E7080/MK-7902) in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma

Conditions

Hepatocellular carcinoma

Brief summary

Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase, Number of participants with ≥1 adverse event (AE), Number of participants with ≥1 serious adverse event (SAE), Number of participants with ≥1 immune-related AE (irAE), Number of participants with ≥1 hepatic AEs, Number of participants discontinuing study treatment due to an AE, 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)

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, Time-To-Progression (TTP) per RECIST 1.1 as assessed by BICR, Overall Survival (OS), ORR per modified RECIST (mRECIST) as assessed by BICR, DOR per mRECIST as assessed by BICR, DCR per mRECIST as assessed by BICR, PFS per mRECIST as assessed by BICR, TTP per mRECIST as assessed by BICR

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Interventions

DRUGLenvatinib

DRUGMK-1308A

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase, Number of participants with ≥1 adverse event (AE), Number of participants with ≥1 serious adverse event (SAE), Number of participants with ≥1 immune-related AE (irAE), Number of participants with ≥1 hepatic AEs, Number of participants discontinuing study treatment due to an AE, 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)	—

Measure

Time frame

Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase, Number of participants with ≥1 adverse event (AE), Number of participants with ≥1 serious adverse event (SAE), Number of participants with ≥1 immune-related AE (irAE), Number of participants with ≥1 hepatic AEs, Number of participants discontinuing study treatment due to an AE, 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)

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Secondary

Measure	Time 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, Time-To-Progression (TTP) per RECIST 1.1 as assessed by BICR, Overall Survival (OS), ORR per modified RECIST (mRECIST) as assessed by BICR, DOR per mRECIST as assessed by BICR, DCR per mRECIST as assessed by BICR, PFS per mRECIST as assessed by BICR, TTP per mRECIST as assessed by BICR	—