Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma
NCT04955743 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-11-24
Summary
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).
Conditions
- Melanoma
- Renal Cell Carcinoma
- Brain Metastases
- PD1/PD-L1 Experienced
- Pembrolizumab
- Lenvatinib
- Metastatic Melanoma
Interventions
- DRUG
-
200 mg intravenous (IV) is administered every 3 weeks
- DRUG
-
20 mg orally (PO) is administered daily
Sponsors & Collaborators
- collaborator INDUSTRY
-
Yale University
lead OTHER
Principal Investigators
-
Harriet Kluger, MD · Professor of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-09
- Primary Completion
- 2025-05-28
- Completion
- 2025-05-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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