A Study of Pembrolizumab+ sEphB4 in Metastatic Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT04486781|
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Urothelial Carcinoma||Drug: Pembrolizumab + sEphB4-HSA||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||December 31, 2020|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Combination Therapy
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.
Drug: Pembrolizumab + sEphB4-HSA
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.
- 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.
- 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) ]Toxicity as assessed by CTCAE v5 will be documented in all eligible patients who begin treatment.
- 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) ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486781
|Contact: Angela Smith, BSemail@example.com|
|United States, California|
|Sarcoma Oncology Center||Recruiting|
|Santa Monica, California, United States, 90403|
|Contact: Victoria Chua 310-552-9999 firstname.lastname@example.org|
|Principal Investigator: Sant Chawla, MD|
|Principal Investigator:||Sant Chawla, MD||Sarcoma Oncology|