Therapeutic Conventional Surgery for Stage II Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage II Bladder Cancer+2 MoreTherapeutic Conventional Surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying avelumab, gemcitabine, and carboplatin as a possible treatment for muscle invasive bladder or upper urinary tract cancer.

Eligible Conditions
  • Stage II Bladder Cancer
  • Bladder Cancer Invading the Muscle of the Bladder Wall
  • Urothelial Carcinoma of the Renal Pelvis and Ureter

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years post-surgery

Year 5
Event-free survival
Year 5
Overall survival
Day 90
Incidence of adverse events
Year 5
pathologic complete response

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Arm A (avelumab, gemcitabine, carboplatin, surgery)
1 of 2
Arm B (surgery)
1 of 2

Experimental Treatment

196 Total Participants · 2 Treatment Groups

Primary Treatment: Therapeutic Conventional Surgery · No Placebo Group · Phase 2

Arm A (avelumab, gemcitabine, carboplatin, surgery)Experimental Group · 4 Interventions: Therapeutic Conventional Surgery, Gemcitabine Hydrochloride, Carboplatin, Avelumab · Intervention Types: Procedure, Drug, Drug, Drug
Arm B (surgery)
Procedure
Experimental Group · 1 Intervention: Therapeutic Conventional Surgery · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Gemcitabine
FDA approved
Carboplatin
FDA approved
Avelumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post-surgery

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
262,757 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,086 Previous Clinical Trials
41,141,450 Total Patients Enrolled
8 Trials studying Stage II Bladder Cancer
314 Patients Enrolled for Stage II Bladder Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have a bimanual examination under anesthesia within 56 days prior to registration.
Participants must not have received prior systemic chemotherapy, immunotherapy or radiotherapy for the treatment of muscle invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (UTUC).
You are eligible if you are at least 18 years of age.