Back to search results

Study of Pembrolizumab + sEphB4 for Metastatic Urothelial Carcinoma

This study is testing a combination of two drugs, Pembrolizumab and sEphB4-HSA, for people with advanced (metastatic or recurrent) urothelial carcinoma (a type of bladder cancer) who have not received prior treatment and cannot or choose not to have chemotherapy. sEphB4-HSA works by potentially stopping cancer cells from multiplying and blocking the growth of blood vessels that feed tumors. The main goal is to see how many patients respond to this combination treatment. You can join if you are 18 or older and have this specific type of cancer. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 38 participants. It is not specified if it's randomized or blinded.
What's involved
You would receive Pembrolizumab and sEphB4-HSA through an IV infusion. sEphB4-HSA is given weekly for three weeks, and Pembrolizumab is given once every three weeks. You can continue treatment as long as it is working and you are stable.
Compensation
Not stated in the trial record.
Follow-up
The study will estimate the overall response rate from study entry until completion, which is an average of 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04486781

A Study of Pembrolizumab+ sEphB4 in Metastatic Urothelial Carcinoma

UNKNOWN
PHASE2Ages 18+InterventionalTreatment
Vasgene Therapeutics, Inc
~38 participants
Updated 2024-05-02 on ClinicalTrials.gov
What's tested:Pembrolizumab + sEphB4-HSA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over At study entry until completion (average of 60 months)

Conditions

Metastatic Urothelial Carcinoma

Explore related trials

Urothelial Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sarmad Sadeghi, MD · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Jon Cogan, MS
[email protected]
323-221-7818
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Be willing and able to provide written informed consent/assent for the trial.
Age ≥ 18 years.
Be treatment naïve and have advanced (metastatic or recurrent) pathologically proven urothelial carcinoma. Patients progressing more than 12 months of their last dose of platinum-based neoadjuvant or adjuvant chemotherapy are eligible.
Have a performance status of 0 or 1 on the ECOG Performance Scale.
Demonstrate adequate organ function as defined in Table 1., all screening labs should be performed within 10 days of treatment initiation.
Be ineligible for chemotherapy in the assessment of the treating physician or refusing chemotherapy in frontline setting. Cisplatin ineligibility is defined as Cresatinine Clearance (CrCl) \< 60cc/min, NYHA class III hear failure, grade II neuropathy and grade II hearing loss, the latter two also apply to carboplatin-based chemotherapy.
Be approved to begin treatment with pembrolizumab per standard of care and pembrolizumab must be available to the patient. Patient must enroll on this study prior to the receiving the second dose of pembrolizumab and prior to having restaging imaging after receiving pembrolizumab. Other PD1/PDL1 antibodies are now allowed.
Have measurable disease based on RECIST 1.1. We request an OPTIONAL core biopsy from an accessible metastatic site after a minimum of 2 cycles of treatment AND prior to progression of disease to help the investigators better understand the activity of these drugs in tumor tissue.

Exclusion

Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Has a known history of active TB (Bacillus Tuberculosis)
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma potentially cured after surgery or prostate cancer that is under control by hormonal agents.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Treated brain metastases are allowed.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Has New York Heart Association (NYHA) class 3 or 4, myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4HSA or pembrolizumab or places the patient at undue risk for treatment related complications.
Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Uncontrolled hypertension is excluded- systolic blood pressure \>140mmHg or diastolic \>90mmHg. Patients experiencing white coat hypertension the office, may be considered eligible if blood pressure log at home is within acceptable limits AND upon review and agreement from the Sponsor.

What this trial 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 chemotherapyAt study entry until completion (average of 60 months)

    Objective tumor response (OR), a derived endpoint, will be based responses as coded at each evaluation. A patient who experiences either a confirmed complete response (CR) or a confirmed partial response (PR) according to RECIST v1.1, will be classified as having experienced an objective response. To estimate the overall response rate (ORR) of the combination of Pembrolizumab + sEphB4-HSA in this population of patients, the number of patients who experience a confirmed complete response (CR) or a confirmed partial response (PR) will be divided by the number of eligible patients who began treatment.