Larotrectinib + Pembrolizumab for Solid Tumors

DH
Overseen ByDavid Hong, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-center, open-label Phase 1/2 trial evaluating the safety and efficacy of the combination of larotrectinib and pembrolizumab in patients with advanced/metastatic lung adenocarcinoma or melanoma.

Who Is on the Research Team?

DH

David Hong, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic lung adenocarcinoma or melanoma whose cancer has already been treated with an immune checkpoint inhibitor alone. Participants must be healthy enough for more treatment and meet other health requirements.

Inclusion Criteria

Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures
Able to swallow PO medications
Women of childbearing potential (WOCBP) must agree to use adequate contraception prior to study entry, during treatment, and for 4 months after completion; includes detailed criteria for WOCBP and approved contraception methods
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Exclusion Criteria

I do not have an active infection needing treatment right now.
History of severe allergic reaction or known sensitivity to study treatment components
I need to take cyclosporin A or similar medicines.
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What Are the Treatments Tested in This Trial?

Interventions

  • Larotrectinib
  • Pembrolizumab

Trial Overview

The study tests the safety and effectiveness of combining two drugs, larotrectinib and pembrolizumab, in people with certain advanced cancers. All participants receive both drugs at a single research center.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Phase 1 and Phase 2: Treatment with Larotrectinib + PembrolizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+