OncoMatch/Clinical Trials/NCT05064280
Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
Is NCT05064280 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lenvatinib for brain metastases.
Treatment: Pembrolizumab · Lenvatinib — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Excluded: EGFR any mutation
Has NSCLC with an oncogenic driver mutation (mutation[s] in EGFR, ERBB2, or BRAF V600E; fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET; or MET amplification). KRAS or PIK3CA mutation are allowed.
Excluded: HER2 (ERBB2) any mutation
Has NSCLC with an oncogenic driver mutation (mutation[s] in EGFR, ERBB2, or BRAF V600E; fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET; or MET amplification). KRAS or PIK3CA mutation are allowed.
Excluded: BRAF V600E
Has NSCLC with an oncogenic driver mutation (mutation[s] in EGFR, ERBB2, or BRAF V600E; fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET; or MET amplification). KRAS or PIK3CA mutation are allowed.
Excluded: ALK fusion
fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET
Excluded: ROS1 fusion
fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET
Excluded: NTRK fusion
fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET
Excluded: RET fusion
fusion/rearrangement[s] in ALK, ROS1, NTRK, or RET
Excluded: MET amplification
MET amplification
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: lenvatinib (lenvatinib)
Has received prior therapy with lenvatinib
Cannot have received: antiangiogenic tyrosine kinase inhibitor
Has received prior therapy with ... other antiangiogenic tyrosine kinase inhibitor alone or in combination with a PD-1/PD-L1 inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥1000/µL (no G-CSF support within 2 weeks); Platelet count ≥100,000/µL (no transfusion within 2 weeks); Hemoglobin ≥9.0 g/dL; INR/PT/aPTT ≤1.5 × ULN
Kidney function
Creatinine clearance ≥50 mL/min
Liver function
Total bilirubin ≤1.5 × ULN (≤2.0 × ULN if hepatic metastases present); AST and ALT ≤2.5 × ULN (≤5.0 × ULN if hepatic metastases present)
Cardiac function
No significant cardiac impairment (NYHA >II, unstable angina, MI or stroke within 6 months, arrhythmia requiring treatment); QTcF ≤480 ms
Has adequate organ function ... see criteria; Has significant cardiac impairment including but not limited to history of congestive heart failure greater than New York Heart Association Class II ... QTcF >480 ms [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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