At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed unresectable locally advanced or metastatic urothelial cancer (transitional cell carcinoma)
- ✓Stage IV disease at start of first-line chemotherapy
- ✓Measurable disease per RECIST v1.1 prior to first-line chemotherapy
- ✓Completed 4-6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin as first-line chemotherapy
- ✕Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
- ✕Prior immunotherapy including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, CTLA-4 antibodies, or other T-cell co-stimulation/immune checkpoint pathway inhibitors
- ✕Persisting Grade >1 toxicity from prior therapy (alopecia, sensory neuropathy Grade ≤2, or other Grade ≤2 toxicities not constituting safety risk are acceptable)
- ✕Known symptomatic CNS metastases requiring steroids
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
In Brief
A Phase 3 clinical trial evaluating Avelumab, Best Supportive Care, and 1 other intervention for Urothelial Cancer. Completed, enrolled 700 participants across 382 sites in 29 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles