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Site for PSCI 22-124 MAIN-CAV: PHASE III RANDOMIZED TRIAL OF MAINTENANCE CABOZANTINIB AND AVELUMAB VS MAINTENANCE AVELUMAB AFTER FIRST-LINE PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH METASTATIC UROTHELIAL CANCER
To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.
Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
NCT05092958
SITE00001285
Inclusion Criteria:
Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethraPrior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years
Exclusion Criteria:
Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
Kidney & Urinary System, Cancer