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Monoclonal Antibodies
sEphB4-HSA + Pembrolizumab for Cancer
Phase 2
Recruiting
Led By Sarmad Sadeghi, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Criteria specific to the neoadjuvant urothelial cohort (Cohort C): Must have tumor stage ≥T2 AND ≤T4a, N0, M0 (AJCC 8th edition) urothelial carcinoma of the bladder deemed resectable and planned for radical cystectomy with curative intent. T4 due to infiltration of the prostate is allowed.
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN or =< 5 X ULN for subjects with liver metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses a fusion protein and an anti-PD1 antibody. There will be four cohorts of patients with different types of cancer, all of whom have not responded well to other treatments.
Who is the study for?
This trial is for adults with certain advanced solid tumors, specifically metastatic or recurrent urothelial carcinoma that's resistant to platinum-based treatment, and locally advanced prostate cancer. Participants must have adequate organ function, no recent other treatments or surgeries, and agree to use contraception. Those with active pneumonitis, uncontrolled hypertension, known psychiatric disorders affecting cooperation, prior anti-PD-1/PD-L1 therapy or sEphB4-HSA are excluded.Check my eligibility
What is being tested?
The trial tests a combination of sEphB4-HSA (a fusion protein blocking cell surface receptors) and Pembrolizumab (an anti-PD1 antibody) on four cohorts: two for second and third-line treatment of urothelial carcinoma after platinum failure; one as neoadjuvant for muscle invasive urothelial carcinoma; another as neoadjuvant for prostate cancer.See study design
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in various organs due to the body's immune system becoming overactive. There may also be infusion-related reactions from the drugs being administered into the bloodstream and typical chemotherapy-associated effects such as fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is at a stage where surgery to remove it is planned and considered potentially curative.
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My liver function tests are within the required range.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine clearance or GFR, is adequate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicities and adverse events classified according to the Common Terminology Criteria for Adverse Events v4.03
Secondary outcome measures
OR defined as complete response or partial response according to RECIST v 1.1
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (EphB4-HSA and pembrolizumab)Experimental Treatment5 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1, 8, and 15 and pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,118 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,684 Total Patients Enrolled
Sarmad Sadeghi, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder cancer is at a stage where surgery to remove it is planned and considered potentially curative.I have prostate cancer with a Gleason Score of 7 or higher and PSA over 4.0, suitable for surgery.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I have been diagnosed with HIV.Your blood pressure is too high and not under control, with readings above 140/90 mmHg. If your blood pressure appears high only in the doctor's office, you may still be considered eligible if your blood pressure readings at home are within the acceptable range. However, this decision will depend on the Sponsor's review and agreement.My liver function tests are within the required range.My blood clotting time is normal or managed with medication.I am using or willing to use birth control, or I cannot have children due to surgery or menopause.My advanced bladder cancer did not respond to platinum-based treatments.I agree to provide a recent biopsy of my tumor for this study.I had a bladder tissue sample taken within the last 12 weeks that includes muscle.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have an active tuberculosis infection.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or cervical cancer that's been treated.I have stable brain metastases, not on steroids for 7 days, and no carcinomatous meningitis.I have been treated with specific immune therapy drugs before.I am fully active or restricted in physically strenuous activity but can do light work.I have or had lung inflammation not caused by an infection.You are currently taking part in another study or have taken part in a study involving experimental drugs or devices within the last 4 weeks.My blood clotting time is normal or managed if I'm on blood thinners.I have recovered from previous cancer treatments, except for hair loss.My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.I agree to use contraception during and for 120 days after the study.My kidney function, measured by creatinine clearance or GFR, is adequate.You have a history of mental illness or drug/alcohol abuse that could make it difficult for you to follow the trial instructions.I have not received a live vaccine within the last 30 days.My scans show no signs of cancer spread far from the original site.I do not have severe heart issues, uncontrolled diabetes, or severe lung problems that required hospitalization in the last 6 months.I have had bladder treatments but no systemic therapy in the last year.I haven't had cancer treatment in the last 2 weeks and have recovered from any side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (EphB4-HSA and pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for participants in this research effort?
"Affirmative. According to the information found on clinicaltrials.gov, this medical experiment is still seeking participants and was first posted on November 21st 2016 with its most recent update being issued on November 19th 2022. 170 patients are needed across 9 hospitals or clinics."
Answered by AI
How many medical facilities are administering the clinical trial?
"This clinical trial is offering the therapy to patients at University of Kansas Cancer Center in Kansas City, Levine Cancer Institute-Carolinas Medical Center in Charlotte and University of Virginia Cancer Center in Charlottesville among numerous other locations."
Answered by AI
How many individuals can potentially participate in this medical investigation?
"This clinical trial necessitates 170 qualified participants. These individuals can be sourced from the University of Kansas Cancer Center in Kansas City, and Levine Cancer Institute-Carolinas Medical Center in Charlotte, North carolina."
Answered by AI
What ailments can be alleviated by Recombinant EphB4-HSA Fusion Protein?
"Recombinant EphB4-HSA Fusion Protein is often prescribed to manage malignant neoplasms, and additionally can assist patients with unresectable melanoma, microsatellite instability high, and those suffering from disease progression after chemotherapy."
Answered by AI
How secure are the prospects of employing Recombinant EphB4-HSA Fusion Protein in patient care?
"We assign a 2 to Recombinant EphB4-HSA Fusion Protein's safety due to the presence of preliminary data which suggests its safe use, but there is yet no evidence demonstrating efficacy."
Answered by AI
What other exploratory projects have been conducted with Recombinant EphB4-HSA Fusion Protein?
"The original research into recombinant EphB4-HSA Fusion Protein was conducted in 2010 at City of Hope. Since then, 844 studies have been concluded and an additional 965 clinical trials are currently underway; many of which are based out of Kansas City, Kansas."
Answered by AI
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