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Monoclonal Antibodies

Therapeutic Conventional Surgery for Bladder Cancer

Phase 2

Waitlist Available

Research Sponsored by Southwest Oncology Group

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 up to 5 years post-surgery

Awards & highlights

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

Bladder Cancer
Urothelial Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-surgery 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 complete response

Secondary outcome measures

Event-free survival

Incidence of adverse events

Overall survival

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (surgery)Experimental Treatment1 Intervention

Patients undergo standard of care surgery.

Group II: Arm A (avelumab, gemcitabine, carboplatin, surgery)Experimental Treatment4 Interventions

Patients receive avelumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up 4 in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks after final systemic therapy, patients undergo standard of care surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Avelumab

2018

Completed Phase 2

~2450

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,615 Total Patients Enrolled

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

264,974 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,076 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Therapeutic Conventional Surgery for use?

"There is some clinical evidence supporting the safety of this surgical intervention, but none for its efficacy, so it received a score of 2."

Answered by AI

What types of ailments is Therapeutic Conventional Surgery commonly used to address?

"While it is most often used to treat advanced endometrial cancer, Therapeutic Conventional Surgery can also be used to ameliorate a number of other conditions such as melanoma, lymphoma, non-hodgkin, and advanced sarcoma."

Answered by AI

Could you please list other times when Therapeutic Conventional Surgery has been used in a study?

"At this moment, 1296 clinical trials are underway that focus on Therapeutic Conventional Surgery. Out of those, 366 are in the critical Phase 3. Many of the studies are based in Shanghai, but there are a total of 70292 medical centres running these trials worldwide."

Answered by AI

Are there any available vacancies for patients who wish to participate in this clinical trial?

"From what is indicated on clinicaltrials.gov, this experiment is still in the process of recruiting patients. The posting dates back to October 6th, 2021, with the most recent update on July 6th, 2022. They are looking for a total of 196 individuals from 66 different locations."

Answered by AI

Could you inform me as to how many research facilities are administering this trial currently?

"Missouri Baptist Sullivan Hospital, Saint Joseph Mercy Canton, and Cleveland Clinic Foundation are just some of the 67 sites where this trial is currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)

2022. "Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04871529.