Clinical Trials Directory

Trials / Terminated

TerminatedNCT04871529

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)

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
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
SWOG Cancer Research Network · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 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.

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 (MIBC/UTUC) 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.

Conditions

Interventions

TypeNameDescription
PROCEDURETherapeutic Conventional SurgeryUndergo surgery
DRUGAvelumabGiven IV
DRUGGemcitabine HydrochlorideGiven IV
DRUGCarboplatinGiven IV

Timeline

Start date
2022-08-10
Primary completion
2023-11-14
Completion
2024-06-26
First posted
2021-05-04
Last updated
2024-12-30
Results posted
2024-12-30

Locations

92 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04871529. Inclusion in this directory is not an endorsement.