E7386 + Pembrolizumab for Solid Cancers

Recruiting in Palo Alto (17 mi)

+41 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Eisai Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug (E7386) combined with pembrolizumab and sometimes lenvatinib in patients with certain cancers who have already tried other treatments. The goal is to see if these drugs can stop cancer growth and help the immune system destroy cancer cells.

Research Team

Eligibility Criteria

This trial is for adults with certain advanced solid tumors (melanoma, colorectal cancer, or hepatocellular carcinoma) that have progressed despite previous treatments. Participants must be in good physical condition and have at least one measurable tumor. Specific criteria apply to each type of cancer regarding prior therapies and disease stage.

Inclusion Criteria

My cancer has worsened despite treatment.

I have colorectal cancer and have had 2-4 treatments for it, but they didn't work or I couldn't tolerate them.

I have a tumor that can be measured by CT or MRI.

Exclusion Criteria

I am currently being treated for an infection.

I stopped a cancer treatment due to severe side effects.

My brain metastases are stable, and I haven't needed steroids for 14 days.

Treatment Details

Interventions

• E7386 (Microtubule Inhibitor)
• Lenvatinib (Tyrosine Kinase Inhibitor)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The study tests E7386 combined with pembrolizumab for safety, tolerability, and the optimal dose in Phase 1b. In Phase 2, it evaluates how well this combination works on melanoma, colorectal cancer, and hepatocellular carcinoma; plus lenvatinib is added for some liver cancer patients.

Participant Groups

Group I: Phase 2: E7386 + Pembrolizumab + Lenvatinib Experimental Treatment 3 Interventions

Participants will be randomized to receive E7386 Dose 1 (Cohort 1) or Dose 2 (Cohort 2) tablet, BID, orally in combination with pembrolizumab 200 mg Q3W IV infusion plus lenvatinib 8 mg capsule, orally, once daily (QD) continuously in 21-days treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study. The dose of treatment depends on tolerability data of both Cohorts.

Group II: Phase 1b and 2: E7386 + Pembrolizumab Experimental Treatment 2 Interventions

Participants will receive E7386 twice daily (BID) along with pembrolizumab 200 mg intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day treatment cycle until RP2D is determined in Phase 1b. The recommended dose for Phase 2 part of the study will be based on Phase 1b result. Participants will continue to receive study treatment in Phase 2 part until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study.

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University