Phase 2 Study of Pembrolizumab and Lenvatinib for Brain Metastases
This study is testing a combination of two drugs, pembrolizumab and lenvatinib, for people with brain metastases (cancer that has spread to the brain) from triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or other solid tumors. Pembrolizumab is given by IV and lenvatinib is taken by mouth. Researchers want to see how well this combination shrinks tumors in the brain. They will also look at the safety of the treatment. You may be eligible if you are at least 18 years old and have one of these cancer types with brain metastases. The study aims to enroll about 104 participants.
- Study design
- This is a single-center, open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll approximately 104 participants across three groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint will be measured through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05064280
Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~104 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:PembrolizumabLenvatinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To establish the intracranial ORR of the pembrolizumab and lenvatinib combination in patients with TNBC or NSCLC and brain metastases, as assessed according to the modified RECIST
Measured over through study completion, an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Jordi Rodon Ahnert, MD, PhD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Previous SRS and excision of up to 5 brain metastases are permitted at least 3 weeks prior to study treatment initiation, provided that neurologic sequelae have completely resolved and measurable untreated lesion(s) remain. If the patient had prior whole brain radiation therapy or SRS, progression in any measurable brain metastasis must have occurred at least 1 month after the end of radiation therapy for the irradiated lesion to be counted as measurable.
Patients can have asymptomatic (no neurologic signs or symptoms, not requiring immediate local intervention \[surgery or radiosurgery\] or systemic glucocorticoid therapy \[within 10 days prior to study treatment initiation\]) OR minimally symptomatic brain metastases (requiring ≤10 mg prednisone or equivalent per day and not requiring immediate surgical or radiation therapy in the opinion of the treating investigator and a radiation therapy or neurosurgical consultant). 3. Extracranial disease is not required and if present, it can be measurable or non-measurable (RECIST v1.1). 4. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Absolute neutrophil count ≥1000/µL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
Platelet count ≥100 000/µL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
Hemoglobin ≥9.0 g/dL
Total bilirubin ≤1.5 × upper limit of normal (ULN); if hepatic metastases are present, ≤2.0 × ULN
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN
Creatinine clearance ≥50 mL/min
International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. 10. Adequately controlled blood pressure with 0 or 1 antihypertensive medication (defined as blood pressure ≤150/90 mmHg at screening and no changes in antihypertensive medication within 7 days of Day 1 of Cycle 1). 11. Hepatitis B and C screening tests are not required unless:
Known history of HBV or HCV infection
As mandated by local health authority 11.1 Hepatitis B positive subjects
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
Exclusion
Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with immunotherapy-related AEs of a permanent nature but manageable (hypothyroidism on thyroid hormone replacement, vitiligo, etc.) are eligible.
Patients must have recovered adequately from any complications from major surgery. Withhold lenvatinib treatment for at least 1 week prior to elective surgery. Do not administer lenvatinib for at least 2 weeks following major surgery and until adequate wound healing. 6. Has received radiotherapy within 14 days prior to study treatment initiation. Patients must have recovered from all radiation-related toxicities, not require corticosteroids in dosing exceeding 10 mg daily of prednisone equivalent, and not have had radiation pneumonitis. Any radiation to the brain or spinal cord/cauda equina must have been completed within \>3 weeks from study treatment initiation. 7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to study treatment initiation. Administration of killed vaccines is allowed. 8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days or 5 half-lives, whichever is shorter, prior to study treatment initiation.
Known history of HBV and HCV infection
As mandated by local health authority 19. Active tuberculosis (Bacillus Tuberculosis). 20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 22. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. 23. GI tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis). 24. Unable to swallow and retain oral medications. 25. Has significant cardiac impairment including but not limited to history of congestive heart failure greater than New York Heart Association Class II (Appendix 8), unstable angina, myocardial infarction or stroke within previous 6 months, or cardiac arrhythmia requiring medical treatment at the time of screening. 26. Has prolongation of QTc using Fridericia's formula (QTcF) to \>480 ms. 27. Has gastric or esophageal varices that may require treatment. 28. Having a GI bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) with 28 days of enrollment. 29. Has bleeding or thrombotic disorder(s) or uses anticoagulants such as warfarin or similar agents requiring therapeutic INR monitoring. Treatment with low molecular weight heparin is allowed. 30. Electrolyte abnormalities that have not been corrected. 31. Patients having \>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours. 32. Has had an allogeneic tissue/solid organ transplant. 33. Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.
What this trial measures
- To establish the intracranial ORR of the pembrolizumab and lenvatinib combination in patients with TNBC or NSCLC and brain metastases, as assessed according to the modified RECISTthrough study completion, an average of 1 year