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Alkylating agents

Cohort III (Durvalumab, carbo-gem) for Bladder Cancer

Phase 2
Waitlist Available
Led By Sandy Srinivas
Research Sponsored by Stanford University
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 at 120 days
Awards & highlights

Study Summary

This study is evaluating whether adding an immunotherapy drug to standard chemotherapy may improve outcomes for patients with bladder cancer.

Eligible Conditions
  • Bladder Cancer
  • Infiltrating Bladder Urothelial Carcinoma
  • Bladder Urothelial Carcinoma
  • Urothelial Carcinoma of the Bladder
  • Bladder Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Grade 3-5 Adverse Events
Secondary outcome measures
Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort III (Durvalumab, carbo-gem)Experimental Treatment4 Interventions
Durvalumab (MEDI4736), at 1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Carboplatin: AUC 5 on Cycle Day 1 and gemcitabine 1,000 mg/m2 on Cycle Day 1 and Day 8 in 21 day cycles (3 weeks). Patients undergo cystectomy within 6 weeks.
Group II: Cohort II (durvalumab, cis-gem)Experimental Treatment4 Interventions
Durvalumab (MEDI4736), at 1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Cisplatin 70 mg/m2 on Cycle Day 2, and gemcitabine 1,000 mg/m2 on Cycle Day 1 and Day 8 in 21 day cycles (3 weeks). Patients undergo cystectomy within 6 weeks.
Group III: Cohort I (durvalumab, DD MVAC)Experimental Treatment6 Interventions
Durvalumab (MEDI4736), at1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Dose Dense Methotrexate, Vinblastine, Doxorubicin, Cisplatin (DD MVAC), in 14 day cycles (2 weeks), Methotrexate 30 mg/m2 on Cycle Day 1, Vinblastine 3 mg/m2 on Cycle Day 2, Doxorubicin 30 mg/m2 on Cycle Day 2 and Cisplatin 70 mg/m2 on Cycle Day 2. Patients undergo cystectomy within 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Cystectomy
2014
Completed Phase 2
~120
Durvalumab
2017
Completed Phase 2
~3870
Methotrexate
2013
Completed Phase 4
~3800
Gemcitabine
2017
Completed Phase 3
~2070
Doxorubicin
2012
Completed Phase 3
~7940
Vinblastine
1998
Completed Phase 3
~5260

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,253 Previous Clinical Trials
288,537,741 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,383 Previous Clinical Trials
17,333,898 Total Patients Enrolled
Sandy SrinivasPrincipal InvestigatorStanford Cancer Institute Palo Alto
1 Previous Clinical Trials
2 Total Patients Enrolled

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
Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
2019. "Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03912818.
~1 spots leftby Apr 2025
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