Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04955743
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    200 mg intravenous (IV) is administered every 3 weeks
  • Lenvatinib — DRUG
    20 mg orally (PO) is administered daily

Study Details

This is a phase 2, Simon's 2-stage designed study with 2 cohorts of anti-PD-1/PD-L1 experienced patients with untreated brain metastases: 1) melanoma and 2) renal cell carcinoma (RCC).

Key Dates

Start date
Feb 9, 2022
Status verified
Nov 2025
Primary completion
May 28, 2025
Completion
May 28, 2025

Study Design

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

Arms

  • Experimental: Cohort 1: Melanoma
    Participants who are melanoma (PD-1/PD-L1-experienced)
  • Experimental: Cohort 2: Renal Cell Carcinoma
    Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).

Primary Outcome Measure

Best Brain Metastasis Response Rate (BMRR) [ Time Frame: up to 2 years from the start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06517-3534-

Related coverage on Hipa.ai

Find similar trials in New Haven, CT

By condition
MelanomaKidney cancer
By specialty
OncologySkin cancerDermatologyUrology
By research site
Yale University· New Haven, CT

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