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Monoclonal Antibodies
Pembrolizumab + sEphB4 for Cancer
Phase 2
Recruiting
Led By Sant Chawla, MD
Research Sponsored by Vasgene Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a performance status of 0 or 1 on the ECOG Performance Scale
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study entry until completion (average of 60 months)
Awards & highlights
Study Summary
This trial is testing a new combination therapy for people with urothelial carcinoma who are ineligible or refuse chemotherapy.
Who is the study for?
This trial is for adults with advanced urothelial carcinoma who haven't been treated yet and can't have or don't want chemotherapy. They should be in good health overall, able to consent, and not have certain other medical conditions like active brain metastases, immune deficiencies, uncontrolled high blood pressure, or recent live vaccines.Check my eligibility
What is being tested?
The study tests a combination of Pembrolizumab (an immunotherapy drug) and sEphB4-HSA (a protein that may stop tumor growth), focusing on patients with untreated advanced urothelial carcinoma ineligible for or refusing chemotherapy.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions from the treatment administration process, fatigue, possible changes in liver function tests and risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Select...
I have advanced bladder cancer and haven't received any treatment for it yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study entry until completion (average of 60 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study entry until completion (average of 60 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Estimate of the overall response rate (ORR) of the combination of Pembrolizumab + sEphB4-HSA in the patients with previously untreated advanced (metastatic or recurrent) urothelial carcinoma who are chemotherapy ineligible or who refuse chemotherapy
Secondary outcome measures
To determine the tolerbility of the combination of Pembrolizumab + sEphB4-HSA in patients with previously untreated advanced urothelial carcinoma is more effective than the single agent pembrolizumab.
To estimate the overall survival (OS) in these patients
To estimate the progression free survival (PFS) in these patients
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment1 Intervention
All study participants will receive Pembrolizumab + sEphB4-HSA through a needle in a vein in their arm for an hour in an outpatient clinic. Pembrolizumab will be given at Day 1 of each 3 week cycle. The study drug (sEphB4-HSA) will be given at Day 1, 8, and 15 of each 3 week cycle.
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Who is running the clinical trial?
Vasgene Therapeutics, IncLead Sponsor
7 Previous Clinical Trials
268 Total Patients Enrolled
Sant Chawla, MDPrincipal InvestigatorSarcoma Oncology
1 Previous Clinical Trials
23 Total Patients Enrolled
Sarmad Sadeghi, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured and tracked using scans.I have a history of active tuberculosis.I have been diagnosed with HIV.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 another cancer besides the one being studied, but it's either not growing or only needs minimal treatment.I have brain metastases or carcinomatous meningitis, but treated brain metastases are okay.I have not received a live vaccine within the last 30 days, except for the flu shot.I am fully active or restricted in physically strenuous activity but can do light work.My recent tests show my organs are functioning well.I am approved and can access pembrolizumab treatment before my second dose and restaging imaging.I cannot or choose not to have chemotherapy as my first treatment.I agree to optionally provide any surgical samples taken during my treatment.I do not have severe heart issues, uncontrolled diabetes, or severe lung problems that required hospitalization in the last 6 months.I am 18 years old or older.I have advanced bladder cancer and haven't received any treatment for it yet.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
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.
What potential adverse effects should one be aware of when utilizing the combination treatment of Pembrolizumab + sEphB4-HSA?
"Our team at Power assigned a safety rating of 2 to Pembrolizumab + sEphB4-HSA, as the available data only supports its security and not yet its efficacy."
Answered by AI
Is participation in this trial open at this time?
"Based on the information posted to clinicaltrials.gov, this medical trial is still seeking potential participants. It was initially advertised on August 14th 2020 and made its last update October 11th 2022."
Answered by AI
How many participants are currently involved in this clinical trial?
"Affirmative. There is evidence on clinicaltrials.gov that this research endeavour, which was initially published on August 14th 2020, is presently recruiting patients. 38 volunteers need to be sourced from a single medical site."
Answered by AI
Are there any previously published accounts of Pembrolizumab in combination with sEphB4-HSA?
"At present, there are 965 active experiments with Pembrolizumab + sEphB4-HSA of which 122 have reached Phase 3. Most trials for this combination are located in Houston, Texas; however, globally the number of medical centres conducting research is 35744."
Answered by AI
What kind of disorders is Pembrolizumab + sEphB4-HSA employed to address?
"Pembrolizumab + sEphB4-HSA is the preferred medical treatment for malignant neoplasms. Additionally, this combination has proved effective in treating conditions such as advanced melanoma, microsatellite instability high, and cases of chemotherapy resistance."
Answered by AI
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