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NCT05064280 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
A Phase 2 study of Brain Metastases and Tumor, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT05064280: Recruiting Phase 2 study of Brain Metastases and Tumor, sponsored by M.D. Anderson Cancer Center.
NCT05064280 is a Phase 2 study of Brain Metastases and Tumor that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 104 participants, below the 211-participant average among 67 other Brain Metastases trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064280, a Phase 2 study of Brain Metastases and Tumor, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Lenvatinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2022-01-20 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 2 |
What NCT05064280 shows while recruiting
NCT05064280 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 211-participant average among 67 other Brain Metastases trials with a reported enrollment target (51% lower).
The record links to 2 conditions, with Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05064280 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05064280 about?
NCT05064280 is a clinical study titled "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 c...
What is the current status of trial NCT05064280?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2022-01-20. Estimated completion is 2028-02-28.
What conditions does trial NCT05064280 study?
This clinical trial studies the following conditions: Brain Metastases, Tumor.
What interventions are being tested in trial NCT05064280?
The interventions under investigation include: Pembrolizumab (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05064280?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05064280 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Metastases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05064280's enrollment target sits among peer trials
104 13th of 67 higher than 55 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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