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NCT03835533 · ClinicalTrials.gov registry record · Phase 1
Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations
A Phase 1 study, sponsored by Parker Institute for Cancer Immunotherapy.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03835533: Completed Phase 1 study, sponsored by Parker Institute for Cancer Immunotherapy.
NCT03835533 is a Phase 1 study that has completed, run by Parker Institute for Cancer Immunotherapy. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03835533, a Phase 1 study, has completed, sponsored by Parker Institute for Cancer Immunotherapy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study 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).
Primary Outcome
An AE is any event that either occurs after the initiation of study drug, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the drug. An SAE is any AE that suggests a significant hazard, contraindication, side effect, or untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant
Interventions
- DRUG NKTR-214 (Cohort A)
- DRUG Nivolumab (Cohort A, B and C)
- RADIATION Stereotactic body radiation therapy (SBRT) (Cohort B)
- DRUG CDX-301 (Cohort B and C)
- DRUG Poly-ICLC (Cohort B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-06-21 |
| Est. Completion | 2022-10-03 |
| Phase | Phase 1 |
What the finished NCT03835533 record still lists
NCT03835533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 5 interventions - of which NKTR-214 (Cohort A) is the first listed.
NCT03835533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03835533 about?
NCT03835533 is a clinical study titled "Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations". 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, enza...
What is the current status of trial NCT03835533?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-06-21. Estimated completion is 2022-10-03.
What interventions are being tested in trial NCT03835533?
The interventions under investigation include: NKTR-214 (Cohort A) (DRUG), Nivolumab (Cohort A, B and C) (DRUG), Stereotactic body radiation therapy (SBRT) (Cohort B) (RADIATION), CDX-301 (Cohort B and C) (DRUG), Poly-ICLC (Cohort B) (DRUG).
Who is sponsoring clinical trial NCT03835533?
This trial is sponsored by Parker Institute for Cancer Immunotherapy, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03835533's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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