POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC

PHASE1RecruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

May 3, 2023

Primary Completion Date

March 8, 2028

Study Completion Date

January 9, 2029

Conditions
Advanced CancerNon Small Cell Lung Cancer
Interventions
DRUG

Tepotinib

Tepotinib hydrochloride hydrate will be supplied as film coated tablets. The 250 mg oval, white-pink film-coated tablets contain the excipients mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry II pink. All formulations are intended for oral administration. Refer to pharmacy manual for formulation and strength information.

DRUG

Pembrolizumab

"Pembrolizumab Solution for Infusion 100 mg/vial is a liquid drug product supplied as a clear to opalescent solution, essentially free of visible particles, in Type I glass vials and manufactured using the fully formulated drug substance with L-histidine as buffering agent, polysorbate 80 as surfactant, and sucrose as stabilizer/tonicity modifier.~Pembrolizumab Solution for Infusion can be further diluted with normal saline or 5% dextrose in the concentration range of 1 to 10 mg/mL in IV containers made of polyvinyl chloride (PVC) or non-PVC material."

Trial Locations (4)

SM2 5PT

RECRUITING

DDU, Royal Marsden Hospital NHS Foundation Trust, Sutton

NW1 2BU

NOT_YET_RECRUITING

University College London Hospitals NHS Foundation Trust, London

SW3 6JJ

RECRUITING

Lung Unit, Royal Marsden Hospital NHS Foundation Trust, London

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

Institute of Cancer Research, United Kingdom

OTHER