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Monoclonal Antibodies

Pembrolizumab + sEphB4 for Cancer

Santa Monica, CA

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

Must not have

Has a known history of active TB (Bacillus Tuberculosis)

Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study entry until completion (average of 60 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for people with urothelial carcinoma who are ineligible or refuse chemotherapy.

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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 below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have advanced bladder cancer and haven't received any treatment for it yet.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of active tuberculosis.

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I have been diagnosed with HIV.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have brain metastases or carcinomatous meningitis, but treated brain metastases are okay.

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I do not have severe heart issues, uncontrolled diabetes, or severe lung problems that required hospitalization in the last 6 months.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study entry until completion (average of 60 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met