Metastatic Urothelial CarcinomaPhase 2NCT04486781
A Study of Pembrolizumab+ sEphB4 in Metastatic Urothelial Carcinoma
A Phase 2 study testing Pembrolizumab + sEphB4-HSA in people with Metastatic Urothelial Carcinoma, run by Vasgene Therapeutics, Inc at 1 site in United States.
Trial summary
sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to evaluate the combination of Pembrolizumab + sEphB4-HSA in the population of patients with previously untreated advanced (metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Urothelial Carcinoma
- What is being tested?
- Pembrolizumab + sEphB4-HSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- In addition, we request an OPTIONAL collection of any surgical specimens obtained per standard of care during the study. For instance, specimens from metastasectomy while patient is undergoing therapy on this study.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sarcoma Oncology Center
Santa Monica, California, 90403
Victoria Chua, 310-552-9999, vchua@sarcomaoncology.com
Sant Chawla, MD
About this study
Official title: A Phase II Trial of Pembrolizumab as Standard of Care + sEphB4-HSA in Chemotherapy Ineligible or Chemotherapy Refusing Patients With Metastatic Urothelial Carcinoma
sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to evaluate the combination of Pembrolizumab + sEphB4-HSA in the population of patients with previously untreated advanced (metastatic or recurrent) urothelial carcinoma who are chemotherapy ineligible or who refuse chemotherapy.
Read the detailed description
The combination of Pembrolizumab + sEphB4-HSA will be given through an intravenous infusion (into a vein). Each cycle of sEphB4-HSA will be given at Day 1, 8, and 15 of each 3 week cycle. Each cycle of Pembrolizumab will be given at Day 1 of each 3 week cycle.
Participants may continue on study protocol as long as they continue to respond and remains clinically stable on study medication.
Patients may come off treatment for the following reasons:
- Disease progression.
- If tumor resolves.
- For participants who become pregnant.
- Incidence or severity of adverse drug reaction in this or other studies indicates a potential health hazard to subjects.
- Patient withdraws consent.
- Study termination by the Sponsor.
- Participants who are non-compliant with respect to taking drugs, keeping appointments, or having tests required for the evaluation of drug safety and efficacy.
- Participant's condition renders them unacceptable for further treatment in the judgment of the investigator.
- Conditions
- Metastatic Urothelial Carcinoma
- Being tested
- Pembrolizumab + sEphB4-HSA
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab + sEphB4-HSADrug
sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | 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. Receives: Drug: Pembrolizumab + sEphB4-HSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: At study entry until completion (average of 60 months)
Secondary outcomes (3)
To estimate the progression free survival (PFS) in these patients
Toxicity as assessed by CTCAE v5 will be documented in all eligible patients who begin treatment.
Measured: Day 1, 8, 15 (each 3 week cycle), 30 days after last dose (safety follow-up), every 6 weeks (follow-up), every 12 weeks (survival follow-up) (average of 60 months)
To estimate the overall survival (OS) in these patients
Overall survival (OS) is calculated as the time from start of protocol treatment until death from any cause. Patients who are alive at the time of analysis will be censored at the last date that they were documented alive. OS will summarized for all eligible patients who begin treatment.
Measured: Baseline, Day 1, 8, 15 (each 3 week cycle), 30 days after last dose (safety follow-up), every 6 weeks (follow-up), every 12 weeks (survival follow-up) (average of 60 months)
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.
Progression-free survival (PFS) is calculated as the time from start of protocol treatment until documentation of disease progression (as defined by RECIST v1.1) or until death from any cause, whichever comes first. Patients who are alive and have not progressed at the time of analysis will be censored at the last date that they were documented alive and free of progression. In addition, patients who begin another treatment (i.e. other than Pembrolizumab or sEphB4-HSA alone) prior to progressing, will be censored at the time of the start of the other treatment for the primary analysis of this endpoint.
Measured: Day 1, 8, and 15 of each 3 week cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start14 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vasgene Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarmad Sadeghi, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486781
- Sponsor's protocol ID
- UC-001
- Status last verified
- Apr 2024
- First submitted
- 8 Jul 2020
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pembrolizumab as Standard of Care + sEphB4-HSA in Chemotherapy Ineligible or Chemotherapy Refusing Patients With Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04486781
- Acronym / sponsor ID
- UC-001
- Conditions
- Metastatic Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Vasgene Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to evaluate the combination of Pembrolizumab + sEphB4-HSA in the population of patients with previously untreated advanced (metastatic or recurrent) urothelial carcinoma who are chemotherapy ineligible or who refuse chemotherapy.
Detailed description
The combination of Pembrolizumab + sEphB4-HSA will be given through an intravenous infusion (into a vein). Each cycle of sEphB4-HSA will be given at Day 1, 8, and 15 of each 3 week cycle. Each cycle of Pembrolizumab will be given at Day 1 of each 3 week cycle.
Participants may continue on study protocol as long as they continue to respond and remains clinically stable on study medication.
Patients may come off treatment for the following reasons:
- Disease progression.
- If tumor resolves.
- For participants who become pregnant.
- Incidence or severity of adverse drug reaction in this or other studies indicates a potential health hazard to subjects.
- Patient withdraws consent.
- Study termination by the Sponsor.
- Participants who are non-compliant with respect to taking drugs, keeping appointments, or having tests required for the evaluation of drug safety and efficacy.
- Participant's condition renders them unacceptable for further treatment in the judgment of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: Pembrolizumab + sEphB4-HSAAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab + sEphB4-HSAsEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. | Drug | Combination Therapy |
Primary outcome
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
Time frame: At 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.
3 secondary outcomes
To estimate the progression free survival (PFS) in these patients
Time frame: Day 1, 8, 15 (each 3 week cycle), 30 days after last dose (safety follow-up), every 6 weeks (follow-up), every 12 weeks (survival follow-up) (average of 60 months)
To estimate the overall survival (OS) in these patients
Time frame: Baseline, Day 1, 8, 15 (each 3 week cycle), 30 days after last dose (safety follow-up), every 6 weeks (follow-up), every 12 weeks (survival follow-up) (average of 60 months)
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.
Time frame: Day 1, 8, and 15 of each 3 week cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarmad Sadeghi, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab + sEphB4-HSA in people with Metastatic Urothelial Carcinoma, run by Vasgene Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon Cogan, MS (323-221-7818, info@vasgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At study entry until completion (average of 60 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.