A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eisai Inc.
Study ID
NCT05091346
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E7386 — DRUG
    E7386 tablet.
  • Pembrolizumab — DRUG
    Pembrolizumab IV infusion.
  • Lenvatinib — DRUG
    Lenvatinib capsule.

Study Details

The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Key Dates

Start date
Oct 27, 2021
Status verified
Oct 2024
Primary completion
Oct 15, 2024
Completion
Oct 15, 2024

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b and 2: E7386 + Pembrolizumab
    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.
  • Experimental: Phase 2: E7386 + Pembrolizumab + Lenvatinib
    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.

Primary Outcome Measure

Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Cycle length=21 days) ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, Irvine HealthOrangeCalifornia92868-
Florida Cancer SpecialistsFort MyersFlorida33916-
SCRI Florida Cancer Specialists EastWest Palm BeachFlorida33401-
Winship Cancer InstituteAtlantaGeorgia30322-
Barbara Ann Karmanos Cancer CenterDetroitMichigan48201-
Rutgers cancer Institute of NJNew BrunswickNew Jersey08901-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Providence Medical Center Institute Franz ClinicPortlandOregon97213-
Tennessee Oncology PPLCNashvilleTennessee37203-

Related coverage on Hipa.ai

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