A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Urothelial Cancer

Treatments: Other: Best Supportive Care; Biological: Avelumab; Biological: Following the planned interim analysis for this study: Avelumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02603432

B9991001

2015-003262-86 (EudraCT Number)

JAVELIN BLADDER 100 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium
• Stage IV disease at the start of first-line chemotherapy
• Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
• Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
• No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )

Exclusion criteria

• Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
• Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.
• Patients with known symptomatic central nervous system (CNS) metastases requiring steroids
• Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Arm A

Experimental group

Description:

Avelumab plus Best Supportive Care (BSC)

Treatment:

Other: Best Supportive Care

Biological: Avelumab

Arm B

Other group

Description:

Best Supportive Care (BSC) alone Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone. All patients who choose not to receive Avelumab will be discontinued.

Treatment:

Other: Best Supportive Care

Biological: Following the planned interim analysis for this study: Avelumab