A Phase 1/2 Trial Of Larotrectinib And Pembrolizumab In Patients With Solid Tumors Previously Treated With Immune Checkpoint Inhibitor Monotherapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07843550
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Larotrectinib — DRUG
    Taken twice daily
  • Pembrolizumab — DRUG
    Give by IV infused over 30 minutes through an IV line containing a sterile 0.2 µm to 5 µm in-line or add-on filter.

Study Details

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.

Key Dates

First listed
Sep 28, 2026
Start date
Mar 1, 2027
Status verified
Sep 2026
Primary completion
Jul 13, 2027
Completion
Jul 13, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 and Phase 2: Treatment with Larotrectinib + Pembrolizumab
    Larotrectinib and pembrolizumab will be administered on an outpatient basis in 21-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, or discontinuation from the study treatment for any other reason.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
David Hong, MD
[email protected]
713-563-5844
David Hong, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UT MD Anderson· Houston, TX

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