Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors
NCT02717156 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103
Last updated 2025-06-05
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.
Conditions
- Stage IV Bladder Urothelial Carcinoma
- Prostate Cancer
- Urothelial Carcinoma
Interventions
- PROCEDURE
-
Computed Tomography
Correlative studies
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Positron Emission Tomography
Correlative studies
- BIOLOGICAL
-
Recombinant EphB4-HSA Fusion Protein
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Southern California
lead OTHER
Principal Investigators
-
Sarmad Sadeghi, MD · University of Southern California
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-21
- Primary Completion
- 2025-11-21
- Completion
- 2026-11-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
NCT05544929 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
NCT06788912 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
NCT02039674 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
NCT03322566 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
NCT02007070 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
NCT05722015 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
NCT03631784 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
NCT03066778 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
NCT03425643 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer
NCT05467748 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
NCT03515837 ·Status: COMPLETED ·Phase: PHASE3
-
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
NCT04533451 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
NCT03142334 ·Status: COMPLETED ·Phase: PHASE3
-
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
NCT04165070 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2
NCT02733159 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Pembrolizumab (MK-3475) in Chinese Participants With Non-Small-Cell Lung Cancer (MK-3475-032/KEYNOTE-032)
NCT02835690 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
NCT02220894 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)
NCT02142738 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)
NCT02256436 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
NCT04938817 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of Pembrolizumab With Single Agent Chemotherapy in Elderly Patients With Advanced NSCLC
NCT04754815 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)
NCT02578680 ·Status: COMPLETED ·Phase: PHASE3
-
Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients
NCT05751187 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
NCT03948763 ·Status: TERMINATED ·Phase: PHASE1
-
MK-3475 as Maintenance Therapy in Extensive Stage SCLC
NCT02359019 ·Status: COMPLETED ·Phase: PHASE2