NCT02403193View on ClinicalTrials.gov

Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

PHASE1CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

October 31, 2021

Study Completion Date

November 24, 2021

Conditions
Non-small Cell Lung Cancer (NSCLC)
Interventions
DRUG

PBF-509_80 mg

PBF-509: 80 mg, PO, twice daily (BID)

DRUG

PBF-509_160 mg

PBF-509: 160 mg, PO, twice daily (BID)

DRUG

PBF-509_320 mg

PBF-509: 320 mg, PO, twice daily (BID)

DRUG

PBF-509_640 mg

PBF-509: 640 mg, PO, twice daily (BID)

DRUG

Combo PBF-509 (160 mg) + PDR001

Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally

DRUG

Combo PBF-509 (320 mg) + PDR001

Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally

DRUG

Combo PBF-509 (640 mg) + PDR001

Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally

DRUG

RP2D (PBF-509+PDR001)_immuno naïve

Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally

DRUG

Experimental: RP2D (PBF-509+PDR001)_immuno treated

Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally

Trial Locations (1)

33612

H.Lee Moffitt Cancer center, Tampa

Sponsors

Collaborators (1)

Novartis
All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

lead

Palobiofarma SL

INDUSTRY