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

NCT03835533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-04-12

Study results available
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Summary

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).

Conditions

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

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • Oncovir, Inc.

    collaborator INDUSTRY

  • Parker Institute for Cancer Immunotherapy

    lead OTHER

Principal Investigators

  • Parker Institute for Cancer Immunotherapy · Parker Institute for Cancer Immunotherapy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2022-10-03
Completion
2022-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835533 on ClinicalTrials.gov