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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 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.

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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

Brain Metastases Tumor

Interventions

  • DRUG Pembrolizumab
  • DRUG Lenvatinib

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2022-01-20
Est. Completion 2028-02-28
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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What the Registry Record Tells You About NCT05064280

The ClinicalTrials.gov registry entry for NCT05064280 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 211-participant average among 67 other Brain Metastases trials with a reported enrollment target (51% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.