Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Part of paid clinical trials in Duarte, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03797326
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    Administered as an IV infusion on Day 1 Q3W.
  • Lenvatinib — DRUG
    Administered orally once a day during each 21-day cycle.

Study Details

The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

Key Dates

Start date
Feb 12, 2019
Status verified
Apr 2026
Primary completion
Oct 28, 2024
Completion
Oct 28, 2024

Study Design

Enrollment
611 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Lenvatinib (Arm 1)
    Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
  • Experimental: Lenvatinib Monotherapy (Arm 2)
    Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Primary Outcome Measure

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment [ Time Frame: Up to approximately 66 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
City of Hope ( Site 0002)DuarteCalifornia91010-
Cedars Sinai Medical Center ( Site 0003)Los AngelesCalifornia90048-
University of California Davis Comprehensive Cancer Center ( Site 0005)SacramentoCalifornia95817-
University of Colorado, Anschutz Cancer Pavilion ( Site 0007)AuroraColorado80045-
University of Florida-Health Cancer Center-Orlando ( Site 0015)OrlandoFlorida32806-
Rutgers Cancer Institute of New Jersey ( Site 0009)New BrunswickNew Jersey08901-
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)New YorkNew York10016-
Sanford Fargo Medical Center ( Site 0059)FargoNorth Dakota58102-
Lehigh Valley Hospital- Cedar Crest ( Site 0047)AllentownPennsylvania18103-
Sanford Cancer Center ( Site 0058)Sioux FallsSouth Dakota57104-
West Cancer Center - East Campus ( Site 0018)GermantownTennessee38138-
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)DallasTexas75230-
Swedish Medical Center ( Site 0021)SeattleWashington98104-
University of Wisconsin Carbone Cancer Center ( Site 0017)MadisonWisconsin53792-0001-

Related coverage on Hipa.ai

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By research site
City of Hope· Duarte, CACedars Sinai Medical Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Colorado, Anschutz Cancer Pavilion· Aurora, COUniversity of Florida-Health Cancer Center-Orlando· Orlando, FLRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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