Trial Outcomes & Findings for 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 NCT04871529)

NCT ID: NCT04871529

Last Updated: 2024-12-30

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Measured once - at the time of surgery
• Results posted on: 2024-12-30

Participant Flow

Participant milestones

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery
Overall Study STARTED	3	3
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery
Overall Study Withdrawal by Subject	0	1
Overall Study Death	0	1
Overall Study Not protocol specified	0	1

Baseline Characteristics

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)

Baseline characteristics by cohort

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) n=3 Participants 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) n=3 Participants Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery	Total n=6 Participants Total of all reporting groups
Age, Continuous	78 Years n=5 Participants	75 Years n=7 Participants	76.5 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic · Yes	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic · No	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White · Yes	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White · No	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Clinical Stage cT2N0M0	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Clinical Stage cT3-4aN0M0	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Performance Status 0-1	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Performance Status 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Creatinine Clearance 0 to < 60 ml/min	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Creatinine Clearance = 60 ml/min	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured once - at the time of surgery

Population: 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

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.

Outcome measures

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) n=2 Participants 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) n=1 Participants Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery
Pathologic Complete Response Complete Response (CR)	1 Participants	0 Participants
Pathologic Complete Response Stable Disease (STA)	1 Participants	0 Participants
Pathologic Complete Response Incomplete (INC)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization to the first event, assessed up to study closure

Population: Study only accrued 6 participants and only 3 participants received treatment. Due to lack of data, this objective can not be analyzed.

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.

Outcome measures

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) n=2 Participants 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) n=1 Participants Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery
Event-free Survival	349 days Interval 217.0 to 481.0	22 days Interval 22.0 to 22.0

SECONDARY outcome

Timeframe: treatment start to 90 days post surgery

Population: Study only accrued 6 participants and only 3 participants received treatment. The three participants who received treatment were assessable for AEs

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.

Outcome measures

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) n=2 Participants 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) n=1 Participants Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery
Incidence of Adverse Events Platelet count decreased	1 Participants	0 Participants
Incidence of Adverse Events Neutrophil count decreased	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years post-surgery

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured once - at the time of surgery

Population: 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.

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.

Outcome measures

Measure	Arm A (Avelumab, Gemcitabine, Carboplatin, Surgery) n=2 Participants 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. Therapeutic Conventional Surgery: Undergo surgery Avelumab: Given IV Gemcitabine Hydrochloride: Given IV Carboplatin: Given IV	Arm B (Surgery) n=1 Participants Patients undergo standard of care surgery. Therapeutic Conventional Surgery: Undergo surgery
Pathologic Complete Response - After 2 Cycles Complete Response (CR)	1 Participants	0 Participants
Pathologic Complete Response - After 2 Cycles Stable Disease (STA)	1 Participants	0 Participants
Pathologic Complete Response - After 2 Cycles Incomplete (INC)	0 Participants	1 Participants

Adverse Events

Gemcitabine + Carboplatin + Avelumab + Surgery

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Surgery Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gemcitabine + Carboplatin + Avelumab + Surgery n=2 participants at risk Participants receive gemcitabine and carboplatin every 3 weeks for up to 4 cycles and avelumab every 2 weeks for up to 6 cycles, followed by radical cystectomy, nephroureterectomy, or ureterectomy. Of the 3 participants assigned to this arm, 2 were eligible and included in the at-risk for all cause mortality population. The two participants who receive treatment are included in the at risk for adverse events population.	Surgery Only n=1 participants at risk Participants receive radical cystectomy, nephroureterectomy, or ureterectomy. Of the 3 participants assigned to this arm, all were eligible and included in the at-risk for all cause mortality population. 1 participant on this arm receive protocol treatment and is included in the at risk for adverse events population.
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
General disorders Disease progression	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
General disorders Infusion site extravasation	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Infections and infestations Upper respiratory infection	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Injury, poisoning and procedural complications Fall	100.0% 2/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations Cardiac troponin T increased	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations Creatinine increased	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations Lymphocyte count decreased	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations Neutrophil count decreased	100.0% 2/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations Platelet count decreased	100.0% 2/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Investigations White blood cell decreased	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Metabolism and nutrition disorders Dehydration	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Metabolism and nutrition disorders Hyperkalemia	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Metabolism and nutrition disorders Hyponatremia	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Nervous system disorders Headache	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Nervous system disorders Peripheral sensory neuropathy	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Psychiatric disorders Hallucinations	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Psychiatric disorders Insomnia	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Renal and urinary disorders Hematuria	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Renal and urinary disorders Urinary frequency	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Renal and urinary disorders Urinary incontinence	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Hiccups	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	100.0% 1/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.
Vascular disorders Vascular disorders-Other	50.0% 1/2 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.	0.00% 0/1 • Treatment start to 90 days post surgery 3 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 2 on the Gemcitabine + Carboplatin + Avelumab + Surgery arm and 1 on the Surgery Only arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0.

Additional Information

Melissa Plets

SWOG

Phone: 206 667 2707

Email: mplets@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60