RecruitingPhase 2NCT05064280

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

104 participants

Start Date

Jan 20, 2022

Study Type

INTERVENTIONAL

Conditions

Brain Metastases Tumor

Summary

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 cell death-1 (PD-1) and angiogenesis inhibitors. The study will be conducted using a Simon's optimal two-stage design, and approximately 87 patients will be enrolled concurrently (n=29 per cohort). The primary endpoint is intracranial objective response rate (ORR) as assessed by the modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase II study tests a combination of pembrolizumab (an immunotherapy) and lenvatinib (a targeted therapy) for solid tumors — including triple-negative breast cancer, non-small cell lung cancer, and other cancers — that have spread to the brain (brain metastases). **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer, non-small cell lung cancer, or another solid tumor - You have at least one measurable brain metastasis (0.5–3 cm on MRI) - You are in good health overall with adequate organ function **You may NOT be eligible if...** - Your brain metastases require steroids or are causing active neurological symptoms - You have had recent treatment for your brain metastases without at least one untreated measurable lesion remaining - You have active autoimmune disease, uncontrolled infection, or conditions that make immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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