CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 43 enrolled
Drug / intervention
NKTR-214 (Cohort A) +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03835533
NCT03835533Phase 1Completed
CompareCT.gov

A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Parker Institute for Cancer Immunotherapy·interventional·Posted Feb 8, 2019·Updated Apr 12, 2024

In Brief

A Phase 1 clinical trial evaluating NKTR-214 (Cohort A), Nivolumab (Cohort A, B and C), and 5 other interventions for Metastatic Castration-resistant Prostate Cancer. Completed, enrolled 43 participants across 6 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-resistant Prostate Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Celldex Therapeutics, Cancer Research Institute, New York City, Inovio Pharmaceuticals, Oncovir, Inc.

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 8, 2019
Enrollment StartJun 21, 2019
Primary CompletionOct 3, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.4 years ago

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 2000device

Electroporation device