A Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

Description

This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC).

Study Start Date

February, 28 2017

Estimated Completion Date

February 2019

Interventions

  • Drug: pembrolizumab (200 mg)
  • Drug: lenvatinib

Study ID

Eisai Inc. -- E7080-J081-116

Status

Recruiting

Trial ID

NCT03006926

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

30

Sponsor

Eisai Inc.

Inclusion Criteria

  • Confirmed diagnosis of hepatocellular carcinoma (HCC)
  • HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
  • Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
  • At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
  • Child-Pugh score A
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
  • Adequately controlled blood pressure
  • Adequate renal function
  • Adequate bone marrow function
  • Adequate blood coagulation function
  • Adequate liver function
  • Males or females age ? 18 years at the time of informed consent
  • Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria

  • Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Any current brain or subdural metastases
  • Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
  • Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Ichan School of Medicine Mount Sinai - New York, New York 183.2 miles None None None
Ronald Reagan UCLA Medical Center - Santa Monica, California 2,605.2 miles None None None
Pacific Henatology and Oncology Associates - San Francisco, California 2,698.0 miles None None None

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