Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871529
Status:
SUSPENDED
Last Update Posted:
2023-08-15
First Post:
2021-04-29
Brief 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
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
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
Status:
SUSPENDED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
undergoing nrevision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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
Detailed Description:
PRIMARY OBJECTIVE
I To compare pathologic complete response pCR pT0N0 with avelumab plus gemcitabine and carboplatin AGCa versus vs no neoadjuvant therapy preceding protocol surgery for muscle-invasive bladder cancer or upper tract urothelial carcinoma MIBCUTUC for participants who are ineligible for cisplatin-based chemotherapy
SECONDARY OBJECTIVES
I To evaluate toxicities with AGCa and to compare resectability rates and surgical complications by arm in this population
II To compare event-free survival EFS with AGCa versus no neoadjuvant therapy in this population
III To compare overall survival OS with AGCa versus no neoadjuvant therapy preceding surgery in this population
IV To compare pathologic complete response pCR pT0N0 with avelumab plus gemcitabine and carboplatin AGCa vs no neoadjuvant therapy preceding protocol surgery in the subset of participants who received at least 2 cycles of neoadjuvant therapy in Arm A
BANKING OBJECTIVE
I To bank tumor tissue blood and urine for future correlative genomic transcriptomic and proteomic studies to discover molecular signatures associated with pCR and resistance
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive avelumab intravenously 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
ARM B Patients undergo standard of care surgery
After completion of study treatment patients are followed up every 12 weeks for years 1-2 every 6 months for year 3 then annually in years 4-5
I To compare pathologic complete response pCR pT0N0 with avelumab plus gemcitabine and carboplatin AGCa versus vs no neoadjuvant therapy preceding protocol surgery for muscle-invasive bladder cancer or upper tract urothelial carcinoma MIBCUTUC for participants who are ineligible for cisplatin-based chemotherapy
SECONDARY OBJECTIVES
I To evaluate toxicities with AGCa and to compare resectability rates and surgical complications by arm in this population
II To compare event-free survival EFS with AGCa versus no neoadjuvant therapy in this population
III To compare overall survival OS with AGCa versus no neoadjuvant therapy preceding surgery in this population
IV To compare pathologic complete response pCR pT0N0 with avelumab plus gemcitabine and carboplatin AGCa vs no neoadjuvant therapy preceding protocol surgery in the subset of participants who received at least 2 cycles of neoadjuvant therapy in Arm A
BANKING OBJECTIVE
I To bank tumor tissue blood and urine for future correlative genomic transcriptomic and proteomic studies to discover molecular signatures associated with pCR and resistance
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive avelumab intravenously 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
ARM B Patients undergo standard of care surgery
After completion of study treatment patients are followed up every 12 weeks for years 1-2 every 6 months for year 3 then annually in years 4-5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |
| NCI-2021-02265 | REGISTRY | None | None |
| S1905 | OTHER | None | None |
| S1905 | OTHER | None | None |