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Terminated Phase 2 Interventional Results available

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 ID: NCT04871529

Public ClinicalTrials.gov record NCT04871529. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 7:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab together with gemcitabine and carboplatin before surgery may work better in lowering the chance of muscle invasive urinary tract cancer growing or spreading, in patients who cannot receive cisplatin therapy compared to surgery alone.

Study identification

NCT ID
NCT04871529
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
SWOG Cancer Research Network
Network
Enrollment
6 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 10, 2022 (Actual)
Primary completion
Nov 14, 2023 (Actual)
Completion
Jun 26, 2024 (Actual)
Last update posted
Dec 30, 2024

2022 – 2024

United States locations

U.S. sites
92
U.S. states
13
U.S. cities
73
Facility City State ZIP Site status
University of Colorado Hospital Aurora Colorado 80045 —
UCHealth Highlands Ranch Hospital Highlands Ranch Colorado 80129 —
AdventHealth Orlando Orlando Florida 32803 —
Queen's Medical Center Honolulu Hawaii 96813 —
Straub Clinic and Hospital Honolulu Hawaii 96813 —
Pali Momi Medical Center ‘Aiea Hawaii 96701 —
Saint Anthony's Health Alton Illinois 62002 —
Illinois CancerCare-Bloomington Bloomington Illinois 61704 —
Illinois CancerCare-Canton Canton Illinois 61520 —
Illinois CancerCare-Carthage Carthage Illinois 62321 —
Northwestern University Chicago Illinois 60611 —
University of Illinois Chicago Illinois 60612 —
Carle at The Riverfront Danville Illinois 61832 —
Cancer Care Specialists of Illinois - Decatur Decatur Illinois 62526 —
Decatur Memorial Hospital Decatur Illinois 62526 —
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois 60115 —
Illinois CancerCare-Dixon Dixon Illinois 61021 —
Carle Physician Group-Effingham Effingham Illinois 62401 —
Crossroads Cancer Center Effingham Illinois 62401 —
Illinois CancerCare-Eureka Eureka Illinois 61530 —
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois 60201 —
Illinois CancerCare-Galesburg Galesburg Illinois 61401 —
Northwestern Medicine Cancer Center Delnor Geneva Illinois 60134 —
NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois 60026 —
NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois 60035 —
Illinois CancerCare-Kewanee Clinic Kewanee Illinois 61443 —
Northwestern Medicine Lake Forest Hospital Lake Forest Illinois 60045 —
Illinois CancerCare-Macomb Macomb Illinois 61455 —
Carle Physician Group-Mattoon/Charleston Mattoon Illinois 61938 —
Cancer Care Center of O'Fallon O'Fallon Illinois 62269 —
Illinois CancerCare-Ottawa Clinic Ottawa Illinois 61350 —
Illinois CancerCare-Pekin Pekin Illinois 61554 —
Illinois CancerCare-Peoria Peoria Illinois 61615 —
Illinois CancerCare-Peru Peru Illinois 61354 —
Illinois CancerCare-Princeton Princeton Illinois 61356 —
Southern Illinois University School of Medicine Springfield Illinois 62702 —
Springfield Clinic Springfield Illinois 62702 —
Memorial Medical Center Springfield Illinois 62781 —
Carle Cancer Center Urbana Illinois 61801 —
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois 60555 —
Illinois CancerCare - Washington Washington Illinois 61571 —
Mary Greeley Medical Center Ames Iowa 50010 —
McFarland Clinic - Ames Ames Iowa 50010 —
McFarland Clinic - Boone Boone Iowa 50036 —
McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa 50501 —
McFarland Clinic - Jefferson Jefferson Iowa 50129 —
McFarland Clinic - Marshalltown Marshalltown Iowa 50158 —
East Jefferson General Hospital Metairie Louisiana 70006 —
LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana 70006 —
Saint Joseph Mercy Hospital Ann Arbor Michigan 48106 —
Saint Joseph Mercy Brighton Brighton Michigan 48114 —
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan 48114 —
Saint Joseph Mercy Canton Canton Michigan 48188 —
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan 48188 —
Saint Joseph Mercy Chelsea Chelsea Michigan 48118 —
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan 48118 —
Hematology Oncology Consultants-Clarkston Clarkston Michigan 48346 —
Newland Medical Associates-Clarkston Clarkston Michigan 48346 —
Genesee Cancer and Blood Disease Treatment Center Flint Michigan 48503 —
Genesee Hematology Oncology PC Flint Michigan 48503 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan 48154 —
Newland Medical Associates-Pontiac Pontiac Michigan 48341 —
Saint Joseph Mercy Oakland Pontiac Michigan 48341 —
Ascension Saint Mary's Hospital Saginaw Michigan 48601 —
Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan 48604 —
Ascension Saint Joseph Hospital Tawas City Michigan 48764 —
Huron Gastroenterology PC Ypsilanti Michigan 48106 —
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan 48197 —
Mercy Hospital Coon Rapids Minnesota 55433 —
Saint Francis Medical Center Cape Girardeau Missouri 63703 —
Parkland Health Center - Farmington Farmington Missouri 63640 —
Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri 63670 —
Missouri Baptist Medical Center St Louis Missouri 63131 —
Missouri Baptist Sullivan Hospital Sullivan Missouri 63080 —
Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri 63127 —
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio 44111 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Cleveland Clinic Cancer Center Mansfield Mansfield Ohio 44906 —
Hillcrest Hospital Cancer Center Mayfield Heights Ohio 44124 —
North Coast Cancer Care Sandusky Ohio 44870 —
ProMedica Flower Hospital Sylvania Ohio 43560 —
Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio 44691 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
UT Southwestern Simmons Cancer Center - RedBird Dallas Texas 75237 —
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 —
UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas 76104 —
UT Southwestern Clinical Center at Richardson/Plano Richardson Texas 75080 —
Marshfield Medical Center-Marshfield Marshfield Wisconsin 54449 —
Marshfield Clinic-Minocqua Center Minocqua Wisconsin 54548 —
Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin 54482 —
Marshfield Medical Center - Weston Weston Wisconsin 54476 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04871529, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 30, 2024 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04871529 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →