M.D. Anderson Cancer Center
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.
Primary Objectives: * To determine the safety and tolerability of the larotrectinib and pembrolizumab combination in patients with advanced/metastatic lung adenocarcinoma or melanoma. * To determine the ORR of the larotrectinib and pembrolizumab combination in patients with advanced/metastatic lung adenocarcinoma or melanoma. Secondary Objective: • To determine the DOR of the larotrectinib and pembrolizumab combination. Exploratory Objective: • To evaluate blood and tissue-based pharmacodynamic biomarkers of the larotrectinib and pembrolizumab combination.
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment in the study. 1. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures. 2. Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures. 3. Age ≥18 years. 4. Histologically documented locally advanced or metastatic lung adenocarcinoma or melanoma. 5. Patients who have previously received ICI monotherapy: • Must have a minimum drug expos…
Taken twice daily
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.
Arctuva estimate
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