Circulating Tumor DNA Response Adapted Treatment De-escalation Metastatic Urothelial Carcinoma (CT-READ)
University of Oklahoma
Summary
The purpose of this clinical trial is to evaluate the effectiveness of pembrolizumab monotherapy following 24 weeks of frontline pembrolizumab \& Enfortumab Vedotin (PEV) in patients with metastatic urothelial cancer (mUC).
Description
This study aims to evaluate the de-escalation of therapy in patients with metastatic urothelial carcinoma (mUC). Patients will begin treatment with first-line (1L) (PEV) per standard of care. After 24 weeks, patients will be assessed for disease progression. Those who demonstrate stable disease or ongoing disease radiographic response and a ≥50% reduction in circulating tumor DNA (ctDNA) levels will enter the de-escalation phase. This phase consists of transitioning from PEV to pembrolizumab monotherapy. If, during the de-escalation period, patients exhibit disease progression or increased tox…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have histologically documented unresectable, locally advanced, or metastatic urothelial carcinoma. * Measurable disease according to the New Response Evaluation Criteria in Solid Tumors (RECIST v1.1)38 a. Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy. * Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. * Archival tumor tissue comp…
Interventions
- DrugPembrolizumab & Enfortumab Vedotin (PEV)
Patients in the study will receive 1L PEV with 1.25 mg/kg of EV on day 1 and day 8 every 21 days, and 200 mg of pembrolizumab every 21 days.
- DrugPembrolizumab
Patients will receive 400 mg of pembrolizumab every 42 days. During the de-escalation period from PEV.
- DrugPembrolizumab & Enfortumab Vedotin (PEV)
If patients experience radiographic progression on pembrolizumab monotherapy, they will undergo rechallenge with PEV.
Location
- OU Health Stephenson Cancer CenterOklahoma City, Oklahoma