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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Parker Institute for Cancer Immunotherapy
Study ID
NCT03835533
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NKTR-214 (Cohort A) — DRUG
    NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
  • Nivolumab (Cohort A, B and C) — DRUG
    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.
  • Stereotactic body radiation therapy (SBRT) (Cohort B) — RADIATION
    Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
  • CDX-301 (Cohort B and C) — DRUG
    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.
  • Poly-ICLC (Cohort B) — DRUG
    Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
  • INO-5151 (Cohort C) — DRUG
    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
  • Cellectra 2000 — DEVICE
    Electroporation device

Study Details

This study is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of immunotherapy combinations in participants with mCRPC who have received prior secondary androgen receptor signaling inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).

Key Dates

Start date
Jun 21, 2019
Status verified
Oct 2023
Primary completion
Oct 3, 2022
Completion
Oct 3, 2022

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: NKTR-214 + Nivolumab
  • Experimental: Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
  • Experimental: Cohort C: CDX-301 + INO-5151 + Nivolumab

Primary Outcome Measure

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: For AEs, from initiation of study drug through 100 days after last dose, up to 24 months. For SAEs, from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Angeles ClinicLos AngelesCalifornia90025-
University of California San FranciscoSan FranciscoCalifornia94158-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mount SinaiNew YorkNew York10029-
Oregon Health & Science UniversityPortlandOregon97239-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Angeles Clinic· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAMemorial Sloan Kettering Cancer Center· New York, NYMount Sinai· New York, NYOregon Health & Science University· Portland, ORThe University of Texas MD Anderson Cancer Center· Houston, TX

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