Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases

This is a single-center, open-label, multi-cohort Phase II study evaluating the efficacy and safety of pembrolizumab in combination with lenvatinib in patients with solid tumors and brain metastases. The study will be comprised of 3 patient cohorts: triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and solid tumor types other than TNBC and NSCLC. Cohort 3 will be comprised of solid tumor types with established (e.g., renal cell carcinoma \[RCC\], endometrial cancer) or preliminary clinical evidence (e.g., gastric cancer, colorectal cancer) of efficacy of programmed cel

Trial Details

NCT ID
NCT05064280
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Pembrolizumab
  • Lenvatinib
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients are eligible to be included in the study only if all the following criteria apply:
  • Male/female patients who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed TNBC (C…
  • Has at least 1 measurable brain metastasis: Presence of at least 1 independently verified measurable brain metastasis in accordance with mRECIST (A…
  • Previous SRS and excision of up to 5 brain metastases are permitted at least 3 weeks prior to study treatment initiation, provided that neurologic …

For full eligibility, visit ClinicalTrials.gov.

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