Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

January 3, 2018

Primary Completion Date

September 21, 2018

Study Completion Date

September 25, 2020

Conditions
Melanoma
Interventions
DRUG

Nivolumab

Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.

DRUG

HF10

1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections. All eligible tumors except one will be treated with HF10 up to the maximum volume allowed. The untreated tumor will be used as an untreated control lesion.

Trial Locations (1)

84112

Huntsman Cancer Institute, Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Takara Bio Inc.

INDUSTRY

lead

University of Utah

OTHER

NCT03259425 - Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma | Biotech Hunter | Biotech Hunter