Trial · NCT04871529

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)

NCT04871529, Phase 2, Terminated, SWOG Cancer Research Network; results first posted 2024-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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). Trials, record NCT04871529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04871529

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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)
NCT number: NCT04871529
Status: Terminated
Phases: Phase 2
Enrollment: 6 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall, Infiltrating Renal Pelvis and Ureter Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8
Interventions: Therapeutic Conventional Surgery, Avelumab, Gemcitabine Hydrochloride, Carboplatin
First posted: 2021-05-04
Last updated: 2024-12-30
Results first posted: 2024-12-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response	Measured once - at the time of surgery	Compare pathologic complete response (pCR) between arms. pCR is defined as s absence of all disease in the surgical specimen from radical cystectomy, nephroureterectomy or ureterectomy as determined by the pathologist at the institution. This is determined by a biopsy taken at the time of surgery.
Secondary	Event-free Survival	From randomization to the first event, assessed up to study closure	Compare event-free survival between arms. Event-free survival is defined as the time from randomization to the first EFS event. For those who do not undergo surgery, event time will be assigned to the date of disease assessment that indicated surgery was no longer indicated or physician decision not to conduct the surgery.
Secondary	Incidence of Adverse Events	treatment start to 90 days post surgery	Evaluate toxicities on both arms. Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported. Measured using CTCAE v5.0.
Secondary	Overall Survival	Up to 5 years post-surgery	To compare overall survival between arms. Overall survival is defined as time from date of registration to date of death due to any cause or patients last known to be alive are censored at their last contact date.
Secondary	Pathologic Complete Response - After 2 Cycles	Measured once - at the time of surgery	Compare pathologic complete response (pCR) between surgery only arm and participants in the avelumab, gemcitabine, carboplatin, surgery arm who received at least two cycles of treatment. pCR is defined as s absence of all disease in the surgical specimen from radical cystectomy, nephroureterectomy or ureterectomy as determined by the pathologist at the institution. This is determined using a biopsy taken at the time of surgery. This outcome uses a subset of participants in arm A who completed exactly 2 cycles of neoadjuvant treatment.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathologic Complete Response	Measured once - at the time of surgery	Study accrued 6 participants and only 3 participants underwent surgery - 1 in the surgery only arm and 2 in the avelumab, gemcitabine, carboplatin, surgery arm. Thus, pathological response data was only available for the 3 participants who received surgery. There is insufficient data for analysis	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event-free Survival	From randomization to the first event, assessed up to study closure	Study only accrued 6 participants and only 3 participants received treatment. Due to lack of data, this objective can not be analyzed.	days	MEDIAN
SECONDARY	Incidence of Adverse Events	treatment start to 90 days post surgery	Study only accrued 6 participants and only 3 participants received treatment. The three participants who received treatment were assessable for AEs	Participants	NUMBER
SECONDARY	Overall Survival	Up to 5 years post-surgery	Study only accrued 6 participants and only 3 participants received treatment. Because of the study's early termination, there was no data collected for this outcome.
SECONDARY	Pathologic Complete Response - After 2 Cycles	Measured once - at the time of surgery	Study accrued 6 participants and only 3 participants underwent surgery - 1 in the surgery only arm and 2 in the avelumab, gemcitabine, carboplatin, surgery arm. Thus, pathological response data was only available for the 3 participants who received surgery. Both participants in the avelumab, gemcitabine, carboplatin, surgery arm completed at least two cycles of treatment. There is insufficient data for analysis.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pathologic Complete Response	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)	Complete Response (CR)	1		Participants
Pathologic Complete Response	Arm B (Surgery)	Complete Response (CR)	0		Participants
Pathologic Complete Response	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)	Stable Disease (STA)	1		Participants
Pathologic Complete Response	Arm B (Surgery)	Stable Disease (STA)	0		Participants
Pathologic Complete Response	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)	Incomplete (INC)	0		Participants
Pathologic Complete Response	Arm B (Surgery)	Incomplete (INC)	1		Participants
Event-free Survival	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)		349	Full Range 217 to 481	days
Event-free Survival	Arm B (Surgery)		22	Full Range 22 to 22	days
Incidence of Adverse Events	Gemcitabine + Carboplatin + Avelumab + Surgery	Neutrophil count decreased	1		Participants
Incidence of Adverse Events	Surgery Only	Neutrophil count decreased	0		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)	3
Overall Study	STARTED	Arm B (Surgery)	3
Overall Study	COMPLETED	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)	3
Overall Study	COMPLETED	Arm B (Surgery)	0
Overall Study	NOT COMPLETED	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery)	0
Overall Study	NOT COMPLETED	Arm B (Surgery)	3

Source ClinicalTrials.gov

Adverse events62

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Gemcitabine + Carboplatin + Avelumab + Surgery	2	2
other	Anemia	Blood and lymphatic system disorders	Surgery Only	0	1
other	Diarrhea	Gastrointestinal disorders	Gemcitabine + Carboplatin + Avelumab + Surgery	1	2
other	Diarrhea	Gastrointestinal disorders	Surgery Only	0	1
other	Disease progression	General disorders	Gemcitabine + Carboplatin + Avelumab + Surgery	0	2
other	Disease progression	General disorders	Surgery Only	1	1
other	Infusion site extravasation	General disorders	Gemcitabine + Carboplatin + Avelumab + Surgery	1	2
other	Infusion site extravasation	General disorders	Surgery Only	0	1
other	Upper respiratory infection	Infections and infestations	Gemcitabine + Carboplatin + Avelumab + Surgery	1	2
other	Upper respiratory infection	Infections and infestations	Surgery Only	0	1

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gemcitabine + Carboplatin + Avelumab + Surgery	0	2
Total, all-cause mortality	Surgery Only	1	1
Total, other adverse events	Gemcitabine + Carboplatin + Avelumab + Surgery	2	2
Total, other adverse events	Surgery Only	1	1
Total, serious adverse events	Gemcitabine + Carboplatin + Avelumab + Surgery	0	2
Total, serious adverse events	Surgery Only	0	1

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gemcitabine + Carboplatin + Avelumab + Surgery vs Surgery Only: deaths from any cause	Trial comparisons
Gemcitabine + Carboplatin + Avelumab + Surgery vs Surgery Only: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04871529

GET https://conductscience.org/api/trials/v1/NCT04871529/events?page=2

API reference For AI assistants