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NCT02717156 · ClinicalTrials.gov registry record · Phase 2
Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors
A Phase 2 study of Prostate Cancer and Urothelial Carcinoma, sponsored by University of Southern California.
- Active
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 9
- Study locations
NCT02717156: Active Phase 2 study of Prostate Cancer and Urothelial Carcinoma, sponsored by University of Southern California.
NCT02717156 is a Phase 2 study of Prostate Cancer and Urothelial Carcinoma that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 103 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02717156, a Phase 2 study of Prostate Cancer and Urothelial Carcinoma, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a multi-cohort single arm phase II/screening trial of the combination of a fusion protein that binds EphrinB2 and blocks interaction with cell surface EphB receptors (sEphB4-HSA) in combination with an anti-PD1 antibody (MK-7435 / Pembrolizumab) for treatment of patients with specific solid tumors. There will be four cohorts in this trial: 1. Cohort A, phase II 2nd line trial of sEphB4-HSA and pembrolizumab for platinum refractory metastatic urothelial carcinoma. 2. Cohort B, phase II 3rd line trial of sEphB4-HSA and pembrolizumab for platinum refractory metastatic urothelial carcinoma. 3. Cohort C, phase II neoadjuvant trial of sEphB4-HSA and pembrolizumab for locally advanced muscle invasive urothelial carcinoma. 4. Cohort D, phase II neoadjuvant trial of sEphB4-HSA and pembrolizumab for locally advanced prostate cancer.
Primary Outcome
All observed toxicities will be summarized in terms of type (organ affected or laboratory determination, severity, and time of onset. Tables will be created to summarize these toxicities and side effects, overall and by course. The proportion of patients who are eligible to begin the 3rd planned cycle will be calculated, using the number of eligible patients who began treatment as the denominator; 95% confidence intervals will be constructed.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Recombinant EphB4-HSA Fusion Protein
Study Locations (9)
California
- City of Hope - Duarte
- LAC+USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology - Newport Beach - Newport Beach
- UC Davis Comprehensive Cancer Center - Sacramento
Kansas
- University of Kansas Cancer Center - Kansas City
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
North Carolina
- Levine Cancer Institute-Carolinas Medical Center - Charlotte
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2026-11-21 |
| Phase | Phase 2 |
What the registry record for NCT02717156 still lists
NCT02717156 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02717156 lists 9 locations in 5 states (California, Kansas, Nevada).
Frequently Asked Questions
What is clinical trial NCT02717156 about?
NCT02717156 is a clinical study titled "Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors". This is a multi-cohort single arm phase II/screening trial of the combination of a fusion protein that binds EphrinB2 and blocks interaction with cell surface EphB receptors (sEphB4-HSA) in combination with an anti-PD1 antibody (MK-7435 / Pembrolizumab) for treatment of patients with specific solid ...
What is the current status of trial NCT02717156?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2016-11-21. Estimated completion is 2026-11-21.
What conditions does trial NCT02717156 study?
This clinical trial studies the following conditions: Prostate Cancer, Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT02717156?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Recombinant EphB4-HSA Fusion Protein (BIOLOGICAL).
Who is sponsoring clinical trial NCT02717156?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02717156 being conducted?
This trial has 9 study locations across California, Kansas, Nevada, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02717156's enrollment target sits among peer trials
103 327th of 735 higher than 409 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate 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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