Sasanlimab for Carcinoma, Transitional Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Transitional Cell+2 More
Sasanlimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to treat bladder cancer by combining an immunotherapy drug with radiation.

Eligible Conditions
  • Carcinoma, Transitional Cell
  • Bladder transitional cell carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: From date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy

At time of radical cystectomy
Clinical benefit rate defined as pathologic complete response (pT0)
Day 30
Incidence of major surgical complications graded by Clavien-Dindo Scale
Week 12
Incidence of adverse events graded by NCI CTCAE version 5.0
Month 24
Health Related Quality of Life for Patients with T2-T4 muscle invasive bladder cancer
Overall survival (OS)
Recurrence free survival (RFS)
Week 4
Composite outcome for Feasibility and Safety

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Open arm
1 of 1

Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Sasanlimab · No Placebo Group · Phase 2

Open armExperimental Group · 3 Interventions: Radical Cystectomy + pelvic lymph node dissection + urinary diversion, Stereotactic Body Radiation Therapy, Sasanlimab · Intervention Types: Procedure, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~590

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy

Who is running the clinical trial?

PfizerIndustry Sponsor
4,264 Previous Clinical Trials
7,108,429 Total Patients Enrolled
11 Trials studying Carcinoma, Transitional Cell
997 Patients Enrolled for Carcinoma, Transitional Cell
The Methodist Hospital Research InstituteLead Sponsor
236 Previous Clinical Trials
35,419 Total Patients Enrolled
1 Trials studying Carcinoma, Transitional Cell
12 Patients Enrolled for Carcinoma, Transitional Cell
Raj Satkunasivam, MDPrincipal InvestigatorHouston Methodist Hospital, Houston Methodist Research Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an elevated serum aspartate and alanine aminotransferase (AST and ALT) and a low total serum bilirubin
The patient has a performance status of 0-2.
You have a bladder cancer that is predominantly urothelial carcinoma.
You have muscle-invasive bladder cancer.
You are able to give informed consent and you are willing and able to comply with the study schedule.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.