Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pembrolizumab & Enfortumab Vedotin (PEV)
Pembrolizumab & Enfortumab Vedotin · 1 trial · 1 indication
Number of patients who achieve PFS at the 3-month mark on pembrolizumab monotherapy. These patients will undergo radiographic assessments to evaluate progression-free survival (PFS).
Number of patients in the de-escalation phase who have reached 6-month PFS while on pembrolizumab monotherapy.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab & Enfortumab Vedotin (PEV) | EXPERIMENTAL | Patients with metastatic urothelial carcinoma (mUC) will initiate first-line (1L) PEV therapy as the standard of care. At 24 weeks, radiographic imaging will be performed to evaluate disease status. Patients who exhibit either stable disease or ongoing radiographic response, accompanied by a ≥50% reduction in circulating tumor DNA (ctDNA) levels, will transition to pembrolizumab monotherapy as part of a treatment de-escalation strategy. Pembrolizumab will be continued until the occurrence of disease progression or unacceptable toxicity. In the event of progression or intolerance, patients will be re-challenged with first-line PEV therapy and continue treatment until completion of the study-defined treatment period. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab & Enfortumab Vedotin (PEV) | DRUG | 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. |
| Pembrolizumab | DRUG | Patients will receive 400 mg of pembrolizumab every 42 days. During the de-escalation period from PEV. |
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 measur...
Pembrolizumab & Enfortumab Vedotin (PEV) is an investigational combination being studied for the treatment of Urothelial Carcinoma. It is currently in Phase 2 clinical development, evaluated in a single-arm trial that is recruiting patients in the United States.
Pembrolizumab & Enfortumab Vedotin targets components of the immune system and tumor cells. Pembrolizumab is an antibody that blocks PD-1, while enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4. The combination is being studied in urothelial carcinoma.
Pembrolizumab & Enfortumab Vedotin is being developed by Natera, Inc. (NASDAQ: NTRA). The company is conducting a Phase 2 clinical trial of this combination in patients with urothelial carcinoma.
Pembrolizumab & Enfortumab Vedotin is in Phase 2 clinical development. It is an investigational therapy, not yet approved by regulatory authorities. The ongoing trial is recruiting participants with urothelial carcinoma.
Pembrolizumab & Enfortumab Vedotin is being evaluated in one Phase 2 clinical trial, NCT07183319, titled 'Circulating Tumor DNA Response In Urothelial Cancer.' This single-arm, uncontrolled study is recruiting 30 participants aged 18 years and older in the United States.
Yes, Pembrolizumab & Enfortumab Vedotin is also known as PEV. The abbreviation PEV is used to refer to this combination therapy, which is currently being studied in a Phase 2 trial for urothelial carcinoma.