2023-505698-34-00
Active, not recruiting
Phase 2
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
Merck Sharp & Dohme LLC8 sites in 3 countries26 target enrollmentStarted: July 27, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 26
- Locations
- 8
- Primary Endpoint
- Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
Overview
Brief Summary
- To assess the safety and tolerability of study intervention with MK-1308A/lenvatinib.
- To evaluate the efficacy of MK-1308A/lenvatinib with respect to 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).
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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 refractory to locoregional therapy, and not amenable to a curative treatment approach
- •Has a Child-Pugh class A liver score within 7 days prior to first dose of study intervention.
- •Has a predicted life expectancy of >3 months
- •Has at least 1 measurable HCC lesion based on RECIST 1.1, confirmed by BICR
- •Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 7 days prior to first dose of study intervention.
- •Participants with controlled hepatitis B will be eligible as long as they meet the following criteria: antiviral therapy for Hepatitis B virus (HBV) must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study drug
- •Has adequately controlled blood pressure with or without antihypertensive medications
- •Has adequate organ function.
Exclusion Criteria
- •Has had esophageal or gastric variceal bleeding within the last 6 months.
- •Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- •Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention
- •Has had a minor surgery (i.e., simple excision) within 7 days prior to the first dose of study intervention (Cycle 1 Day 1)
- •Has serious nonhealing wound, ulcer, or bone fracture
- •Has received any systemic chemotherapy, including anti- vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agents for treatment of HCC
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- •Has received locoregional therapy to liver within 4 weeks prior to the first dose of study intervention
- •Has received prior radiotherapy to a non-liver region within 2 weeks of start of study intervention
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
Outcomes
Primary Outcomes
Number of participants with a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
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 adverse event (AE)
Number of participants with ≥1 serious adverse event (SAE)
Number of participants with ≥1 serious adverse event (SAE)
Number of participants with ≥1 immune-related AE (irAE)
Number of participants with ≥1 immune-related AE (irAE)
Number of participants with ≥1 hepatic AEs
Number of participants with ≥1 hepatic AEs
Number of participants discontinuing study treatment due to an AE
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)
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)
Secondary Outcomes
- 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
Investigators
Ken Hatogai
Scientific
Merck Sharp & Dohme LLC
Study Sites (8)
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