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A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

NCT02501096 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2023-07-20

Study results available
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Summary

This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous \[IV\], every 3 weeks \[Q3W\]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, melanoma or leiomyosarcoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 7 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).

Conditions

Interventions

DRUG

Lenvatinib

Lenvatinib will be administered with water orally once a day (with or without food) continuously in 21-day treatment cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered as a dose of 200 mg Q3W, IV in 21-day treatment cycle.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-22
Primary Completion
2020-08-18
Completion
2022-07-11
FDA Drug
Yes

Countries

  • United States
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02501096 on ClinicalTrials.gov