MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab Versus Maintenance Avelumab After First Line Platinum-Based Chemotherapy in Patients with Metastatic Urothelial Cancer
August 1, 2022
Protocol: Alliance – A032001
Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
- Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell
and mixed transitional/non-transitional cell histologies except for small-cell histology), including N3 only disease prior to start of first-line platinum-based chemotherapy.
- Prior 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 more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more
months prior to registration).
- Tumor objective response of CR, PR, or SD upon completion of first line platinum based chemotherapy.
- The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study.
- 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.
- Age ≥ 18 years.
- ECOG Performance Status of 0 or 1.