Study on Pembrolizumab and sEphB4 for Advanced Urothelial Cancer

Sponsor: Vasgene Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04486781

Provider View

This clinical trial is testing a new treatment combining Pembrolizumab and sEphB4 for patients with advanced urothelial cancer who cannot or choose not to undergo chemotherapy.

Patient Parameters

Program Overview

The study aims to see if a combination of Pembrolizumab and sEphB4-HSA can help control advanced urothelial cancer. sEphB4-HSA may stop cancer cells from growing and block substances that help tumors get nutrients. This trial is for patients with advanced urothelial cancer who haven't had chemotherapy or who can't or don't want to have it.

Description

In this study, participants will receive Pembrolizumab and sEphB4-HSA through an IV (intravenous) drip. sEphB4-HSA will be given on Days 1, 8, and 15 of each 3-week cycle, while Pembrolizumab will be given on Day 1 of each cycle. Participants can continue the treatment as long as it is working and they remain stable.

Participants may stop treatment if:

  • The cancer progresses.
  • The tumor disappears.
  • They become pregnant.
  • There are serious side effects.
  • They choose to withdraw from the study.
  • The study is stopped by the sponsor.
  • They do not follow the study requirements.
  • Their condition makes further treatment unsafe according to the doctor.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide written consent to participate.
  • Must be 18 years or older.
  • Have advanced urothelial cancer that has not been treated before, or cancer that returned more than 12 months after the last chemotherapy.
  • Have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have adequate organ function based on specific lab tests.
  • Be unable or unwilling to receive chemotherapy.
  • Be approved to start Pembrolizumab treatment and enroll in the study before the second dose and before new imaging tests.
  • Have measurable cancer based on specific criteria.
  • Optional: Provide a biopsy from a metastatic site after at least 2 cycles of treatment and before cancer progression.
  • Optional: Provide any surgical specimens obtained during the study.

Exclusion Criteria

  • Have a history of HIV.
  • Have an immune deficiency or are on immunosuppressive therapy within 7 days before starting the study.
  • Have active Hepatitis B or C.
  • Have a history of active tuberculosis.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have another progressing cancer needing treatment, except for certain skin or prostate cancers.
  • Have active cancer in the brain or spinal fluid, unless treated.
  • Are pregnant or breastfeeding, or planning to conceive during the study and for 120 days after.
  • Have severe heart conditions or other serious health issues that make the treatment unsafe.
  • Have received a live vaccine within 30 days before starting the study.
  • Have uncontrolled high blood pressure, unless it is controlled at home and approved by the sponsor.

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