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Pembrolizumab/Quavonlimab

Phase 2

Advanced Hepatocellular Carcinoma | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Aug 13, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04740307Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)PHASE2 COMPLETED 116Mar 16, 2021Jul 29, 2025Aug 13, 202540 United States, China +7
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Study Endpoints
Primary Endpoints
Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
Cycle 1 (Up to approximately 3 weeks)

DLTs will be defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting \>7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for \>1 week (or bilirubin if persists \>4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \>10.0 times upper limit of normal (ULN) or \>10.0 times baseline if baseline \>ULN; any febrile neutropenia Grade 3 or Grade 4; any treatment-related AE that causes the participant to discontinue study intervention during the DLT window; any Grade 5 toxicity

Number of participants with ≥1 adverse event (AE)
Up to approximately 5 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE will be reported.

Number of participants with ≥1 serious adverse event (SAE)
Up to approximately 5 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with an SAE will be reported.

Number of participants with ≥1 immune-related AE (irAE)
Up to approximately 5 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with MK-1308A exposure may represent an immune-related response. irAEs pre-specified for this study include pneumonitis, diarrhea/colitis, Type 1 diabetes mellitus (T1DM) or hyperglycemia, hypophysitis, hyperthyroidism, hypothyroidism, nephritis (grading according to increased creatinine or acute kidney injury), and myocarditis. The number of participants with an irAE will be reported.

Number of participants with ≥1 hepatic AE
Up to approximately 5 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) include any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT \<2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT \>3 × the Baseline level; ALT \>500 U/L regardless of baseline level; total bilirubin \>3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for \>3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE will be reported.

Number of participants discontinuing study treatment due to an AE
Up to approximately 5 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinue study treatment due to an AE will be reported.

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)
Up to approximately 28 months

ORR is defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR.

Secondary Endpoints
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Up to approximately 28 months
Disease Control Rate (DCR) per RECIST 1.1 as assessed by BICR
Up to approximately 28 months
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
Up to approximately 28 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pembrolizumab/Quavonlimab + LenvatinibEXPERIMENTALParticipants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered.
Interventions
NameTypeDescription
Pembrolizumab/QuavonlimabBIOLOGICALPembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
LenvatinibDRUGLenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).
PembrolizumabBIOLOGICALPembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Has an HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) * Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or...

Countries:United StatesChinaItalyJapanPolandSouth KoreaSpainSwitzerlandTaiwan
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