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Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment target: 103 to 70
    • Primary completion date: Nov 21, 2025 to Dec 31, 2027
    • Study completion date: Nov 21, 2026 to Dec 31, 2030
    v15
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 170 to confirmed 103
    • Site details revised at 9 of 9 sites
    v14
  3. Primary completion date: Nov 21, 2023 to Nov 21, 2025
    • Study completion date: Nov 21, 2024 to Nov 21, 2026
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary completion date: Nov 21, 2022 to Nov 21, 2023
    • Study sites: 7 to 9
    • Study completion date: Nov 21, 2023 to Nov 21, 2024
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Enrollment target: 60 to 170v10 Show 4 more changesShow less
    • Study sites: 2 to 7
    • Eligibility criteria expanded, about 160 words
    • Study description expanded, about 166 words
    • Study title shortened, about 2 words
  2. Primary completion date: Nov 21, 2020 to Nov 21, 2022
    • Study completion date: Nov 21, 2021 to Nov 21, 2023
    v9
  3. Primary completion date: Nov 21, 2019 to Nov 21, 2020
    • Study completion date: Nov 21, 2020 to Nov 21, 2021
    v8
  4. Study sites: 1 to 2v7
  5. 2 versions Re-verified since Apr 19, 2017, no change to tracked fieldsv5-v6
  6. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Jun 2016 to Nov 21, 2016
    • Primary completion date: Jun 2019 to Nov 21, 2019
    • Study completion date: Jun 2020 to Nov 21, 2020
    • Site details revised
  7. Study title shortened, about 10 wordsv3
  8. Start date: Mar 2016 to Jun 2016
    • Primary completion date: Mar 2019 to Jun 2019
    • Study completion date: Mar 2020 to Jun 2020
    • Study title shortened, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02717156
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Stage IV Bladder Urothelial Carcinoma, Prostate Cancer, Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell, Prostatic Neoplasms
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov