NCT03206073View on ClinicalTrials.gov

A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

September 24, 2020

Study Completion Date

June 30, 2022

Conditions
Colorectal CancerColorectal CarcinomaColorectal AdenocarcinomaRefractory CancerColorectal Neoplasms
Interventions
DRUG

Durvalumab

1500 mg of durvalumab via intravenous (IV) infusion on Day 1 of each cycle until patients meet off treatment criteria

DRUG

Tremelimumab

300 mg of tremelimumab via intravenous (IV) infusion on Day 1 of cycle 1

BIOLOGICAL

Pexa-Vec

3 x 10E\^8 plaque-forming unit (pfu) (Dose Level (DL) 1) via intravenous (IV) infusion for 4 doses: Day 12, Day 2, Day 16 of Cycle 1 and Day 2 of Cycle 2.

BIOLOGICAL

Pexa-Vec

1 x 10E\^9 pfu (DL 2) via intravenous (IV) infusion for 4 doses: Day 12, Day 2, Day 16 of Cycle 1 and Day 2 of Cycle 2.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT03206073 - A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer | Biotech Hunter | Biotech Hunter