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NCT03333616 · ClinicalTrials.gov registry record · Phase 2
Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors
A Phase 2 study of Genitourinary Cancer and Adrenocortical Carcinoma, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 6
- Study locations
NCT03333616: Active Phase 2 study of Genitourinary Cancer and Adrenocortical Carcinoma, sponsored by Dana-Farber Cancer Institute.
NCT03333616 is a Phase 2 study of Genitourinary Cancer and Adrenocortical Carcinoma that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 100 participants, below the 1,244-participant average among 15 other Genitourinary Cancer trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03333616, a Phase 2 study of Genitourinary Cancer and Adrenocortical Carcinoma, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 6
- Study locations
Study Summary
This research study is studying a combination of drugs as a possible treatment for rare genitourinary malignancies among four cohorts, bladder or upper tract carcinoma with variant histology, adrenocortical carcinoma, other rare genitourinary carcinomas and any genitourinary carcinoma with neuroendocrine differentiation. Given preliminary results, the study is being tested in additional patients with bladder or upper tract carcinoma with variant histology at this time while the adrenocortical carcinoma, other rare genitourinary malignancies arms have closed to accrual -The names of the study drugs involved in this study are: * Nivolumab * Ipilimumab
Primary Outcome
Radiologic disease assessment performed at 12 weeks after initial treatment and then every 6 or 12 weeks. These radiologic disease assessments are evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. This will be conducted by cohort ((1) ACC, (2) Non-urothelial bladder/upper tract cancer and (3) other rare GU tumors)
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Study Locations (6)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
California
- University of California, San Diego Moores Cancer Center - La Jolla
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-12-28 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03333616 still lists
NCT03333616 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,244-participant average among 15 other Genitourinary Cancer trials with a reported enrollment target (92% lower).
The record links to 8 conditions, with Genitourinary Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03333616 lists 6 locations in 5 states (Massachusetts, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT03333616 about?
NCT03333616 is a clinical study titled "Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors". This research study is studying a combination of drugs as a possible treatment for rare genitourinary malignancies among four cohorts, bladder or upper tract carcinoma with variant histology, adrenocortical carcinoma, other rare genitourinary carcinomas and any genitourinary carcinoma with neuroendo...
What is the current status of trial NCT03333616?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-12-28. Estimated completion is 2026-12-31.
What conditions does trial NCT03333616 study?
This clinical trial studies the following conditions: Genitourinary Cancer, Adrenocortical Carcinoma, Penile Cancer, Non-urothelial Bladder, Non-urothelial Upper Tract.
What interventions are being tested in trial NCT03333616?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT03333616?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03333616 being conducted?
This trial has 6 study locations across California, Georgia, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03333616's enrollment target sits among peer trials
100 7th of 15 higher than 7 of 15 other Genitourinary Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Genitourinary Cancer 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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