Protocol: SWOG – S1937
Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.
- Participant must have predominant histologically and cytologically proven urothelial carcinoma in a metastatic site.
- Participant must have evidence of metastatic urothelial carcinoma based on CT or MRI within 28 days prior to registration.
- Participant must have had progression of disease following prior therapy at the discretion of the treating investigator.
- Participants must not require immediate CNS-specific treatment, in the opinion of the treating investigator if they have active brain metastases (defined as new or progressive brain metastases) or leptomeningeal disease.
- Participant must have received previous systemic treatment for metastatic urothelial carcinoma with either a platinum-based chemotherapy regimen, systemic PD1/PDL1 immunotherapy, an antibody drug conjugate such as,
enfortumab vedotin or sacituzumab govitecan (through standard of care or a clinical trial) . There is no limit to the number of prior regimens patient may have received for urothelial carcinoma.
- If participant is a candidate for a platinum-based chemotherapy, then participant must have previously received a platinum-based chemotherapy.
- If participant is a candidate for immunotherapy, then participant must have previously received immunotherapy. If participant is not a candidate for immunotherapy, then participant either: (a) must have had prior anti
PD1/PDL1 antibody therapy; OR (b) must have not been a candidate for anti PD1/PDL1 antibody therapy in the opinion of the treating physician.
- Participant is eligible if platinum based chemotherapy and/or anti PDL/PDL1 antibody therapy was provided in perioperative setting before or after radical cystectomy and if there is evidence of progression to metastatic disease within 12 months of the last dose of therapy. For instance, a patient treated with ddMVAC in neoadjuvant setting, then radical cystectomy followed by adjuvant pembrolizumab on AMBASSADOR trial will meet the requirement for prior/concurrent therapy if progression of disease occurs within 12 months of discontinuation of pembrolizumab.
- Participant must have received any planned surgery prior to registration.
- Participant must not have progressed within 3 months following last dose of gemcitabine.
- Must be at least 18 years of age.
- Zubrod Performance Status 0-2.
- Participants may have a prior or concurrent malignancy provided the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per the opinion of the treating
- Participants must not be planning to take strong or moderate CYP3A or CYP2C8 inhibitors or inducers if randomized to Arm 1 and SOC regimen chosen is Paclitaxel or Docetaxel. Participants receiving strong or moderate CYP3A or
CYP2C8 inducers must discontinue use at least 2 weeks prior to randomization.