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Monoclonal Antibodies

Cisplatin for Bladder Cancer

Phase 2
Waitlist Available
Led By Chethan Ramamurthy, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat bladder cancer. The goal is to see if it is more effective and has fewer side effects than current treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic Tumor Downstaging of >T2 to pT0
Secondary outcome measures
Completion of Surgery
Evaluation of Safety and Tolerability of AGEN1884 Plus AGEN2034 Plus Cisplatin and Gemcitabine
Pathologic Downstaging to <T2 Rate
+1 more
Other outcome measures
Correlate Immune Outcomes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cisplatin, Gemcitabine plus human monoclonal antibodiesExperimental Treatment4 Interventions
The safety run-in of the study will first enroll three patients who will begin treatment with cisplatin and gemcitabine plus AGEN2034 and AGEN1884 as outlined in the treatment plan. These first 3 patients will be assessed for DLTs and there will be a pause in enrollment until all three complete the DLT period. If there are no DLTs in the first 3 patients, we will proceed to further accrual to stage I of phase II. If there is 1 DLT in the initial 3 patients, we will enroll 3 additional patients to the safety run-in. If > 2 DLTs are experienced in the initial 3 patients, the study will be terminated, otherwise additional subjects will be enrolled into the phase ll first stage and reassessed after 2 cycles of therapy and proceed to planned surgery. If criteria are met to continue to the second stage of the Phase II portion of the study, additional patients will be enrolled for an anticipated total of 36 evaluable patients. Patients will be treated and endpoints evaluated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
AGEN2034
2017
Completed Phase 2
~220
AGEN1884
2016
Completed Phase 2
~90
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,410 Total Patients Enrolled
Chethan Ramamurthy, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
2020. "AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430036.
~1 spots leftby Apr 2025
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