Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

June 21, 2019

Primary Completion Date

October 3, 2022

Study Completion Date

October 3, 2022

Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
DRUG

NKTR-214 (Cohort A)

NKTR-214 will be administered intravenously every 3 weeks for up to 2 years

DRUG

Nivolumab (Cohort A, B and C)

Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.

RADIATION

Stereotactic body radiation therapy (SBRT) (Cohort B)

Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1

DRUG

CDX-301 (Cohort B and C)

CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.

DRUG

Poly-ICLC (Cohort B)

Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1

DRUG

INO-5151 (Cohort C)

INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter

DEVICE

Cellectra 2000

Electroporation device

Trial Locations (6)

10029

Mount Sinai, New York

10065

Memorial Sloan Kettering Cancer Center, New York

77030

The University of Texas MD Anderson Cancer Center, Houston

90025

Angeles Clinic, Los Angeles

94158

University of California San Francisco, San Francisco

97239

Oregon Health & Science University, Portland

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Celldex Therapeutics

INDUSTRY

collaborator

Cancer Research Institute, New York City

OTHER

collaborator

Inovio Pharmaceuticals

INDUSTRY

collaborator

Oncovir, Inc.

INDUSTRY

lead

Parker Institute for Cancer Immunotherapy

OTHER

NCT03835533 - Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations | Biotech Hunter | Biotech Hunter