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

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites110 target enrollmentJune 8, 2021

ConditionsAdvanced hepatocellular carcinoma without any prior systemic treatment MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA® (Pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced hepatocellular carcinoma without any prior systemic treatment
Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
Enrollment: 110
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

Eligibility Criteria

Inclusion Criteria

•1\. Has an HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/ cholangiocarcinoma subtypes are not eligible).
•Radiologic confirmation of diagnosis is provided by the study site and confirmed by BICR. Clinically confirmed diagnosis of HCC as per the AASLD criteria, which requires: Radiographically evident cirrhosis o A liver mass that shows arterial phase hyperenhancement on triphasic CT or MRI, AND EITHER:
•\- \> \=20 mm with either nonperipheral portal washout or an enhancing capsule
•\- 10\-19 mm with nonperipheral portal venous washout AND anenhancing capsule
•2\. Has 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.
•3\. Has a Child\-Pugh class A liver score within 7 days prior to first dose of study intervention.
•4\. Has a predicted life expectancy of \>3 months.
•5\. Has at least 1 measurable HCC lesion based on RECIST 1\.1, confirmed by BICR.
•6\. Has an ECOG PS of 0 to 1 within 7 days prior to first dose of study intervention.
•7\. Is at least 18 years of age at the time of providing documented informed consent.

Exclusion Criteria

•1\. Has had esophageal or gastric variceal bleeding within the last 6 months. All participants will be screened for esophageal or gastric varices unless such screening has been performed in the past 3 months before first dose of treatment. If varices are present, they should be treated according to institutional standards before starting study intervention; esophageal or gastric varices that require interventional treatment within 28 days prior to first dose of study drug are excluded.
•2\. Has bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin is permitted.
•3\. Has clinically apparent ascites on physical examination.
•4\. Has inferior vena cava or cardiac involvement of HCC based on imaging, confirmed by BICR.
•5\. Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy. Participants on rifaximin or lactulose
•during Screening to control their hepatic encephalopathy are not allowed.
•6\. Has medical contraindications that preclude all forms of contrastenhanced imaging (CT or MRI).
•7\. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
•8\. Has a preexisting Grade \=3 gastrointestinal or non\-gastrointestinal fistula.
•9\. Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study drug.