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NCT03204812 · ClinicalTrials.gov registry record · Phase 2
Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT03204812: Completed Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03204812 is a Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03204812, a Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Toxicity will be monitored in all patients who receive at least one dose of tremelimumab, even if the patient is not evaluable for the biomarker or efficacy endpoint. Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- BIOLOGICAL Tremelimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2021-04-13 |
| Phase | Phase 2 |
What the finished NCT03204812 record still lists
NCT03204812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (86% lower).
The record links to 6 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT03204812 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03204812 about?
NCT03204812 is a clinical study titled "Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer". This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with mo...
What is the current status of trial NCT03204812?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2017-07-14. Estimated completion is 2021-04-13.
What conditions does trial NCT03204812 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT03204812?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03204812?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03204812 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03204812's enrollment target sits among peer trials
31 78th of 99 higher than 22 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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.
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