Actively Recruiting
Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
104
Participants Needed
1
Research Sites
318 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
E
Eisai Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients at least 18 years old with confirmed triple negative breast cancer, non-small cell lung cancer, or other solid tumors with brain metastases
- At least one measurable brain metastasis between 0.5-3 cm on MRI suitable for repeated assessment
- Previous stereotactic radiosurgery or excision of up to 5 brain metastases allowed if neurologic symptoms have resolved and measurable lesions remain
- Brain metastases may be asymptomatic or minimally symptomatic, not requiring immediate surgery, radiation, or high-dose steroids
- Extracranial disease may be present and can be measurable or non-measurable
- Female participants must not be pregnant, breastfeeding, and either not of childbearing potential or agree to contraception during and after treatment
- Male participants must agree to use contraception during and after treatment and avoid sperm donation
- Written informed consent provided
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function as defined by blood counts, liver and kidney tests within 28 days prior to treatment
- Controlled blood pressure with 0 or 1 antihypertensive medication
- Hepatitis B or C infection allowed if properly treated and viral load undetectable
You will not qualify if you...
- Non-small cell lung cancer with certain oncogenic driver mutations (EGFR, ERBB2, BRAF V600E, ALK, ROS1, NTRK, RET, or MET amplification)
- Hepatocellular carcinoma
- Symptomatic or untreated spinal cord compression or leptomeningeal metastases
- Prior therapy with lenvatinib or antiangiogenic tyrosine kinase inhibitors combined with PD-1/PD-L1 inhibitors
- Recent systemic anticancer therapy or investigational agents within 28 days prior to treatment
- Radiotherapy within 14 days prior to treatment initiation
- Live vaccine within 30 days prior to treatment
- Contraindications to MRI or MRI contrast
- Positive pregnancy test in women of childbearing potential
- Immunodeficiency or ongoing immunosuppressive therapy exceeding 10 mg prednisone daily
- Active infections including HIV, active hepatitis B or C, or tuberculosis
- Additional progressing malignancy requiring treatment within 5 years except certain skin or in situ cancers
- Severe hypersensitivity to pembrolizumab or lenvatinib
- Conditions requiring systemic corticosteroids or immunosuppressive medications within 14 days
- History or current pneumonitis/interstitial lung disease requiring steroids
- Significant cardiac impairments or recent heart events
- Prolonged QTc interval >480 ms
- Gastrointestinal conditions preventing oral medication intake
- Inability to swallow or retain oral medications
- Bleeding or clotting disorders requiring therapeutic anticoagulation
- Electrolyte abnormalities not corrected
- Proteinuria exceeding specified limits
- History of allogeneic tissue or organ transplant
- Radiographic evidence of tumor invasion or encasement of major blood vessels
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jordi Rodon Ahnert, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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