ImmunityBio, Inc.
This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
This is an open label, phase 1b single arm trial with a safety lead-in cohort to determine the preliminary efficacy and safety of EV plus pembrolizumab and NAI in participants with unresectable locally advanced or mUC who are treatment-naïve in the metastatic setting.
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Histologically or cytologically confirmed locally advanced/ mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as \>50% urothelial component is present (mixed histology other than small cell/ neuroendocrine are allowed). 3. No prior systemic treatment for locally advanced/mUC. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. 5. Measurable disease according to RECIST v1.1. 6. Prior perioperative systemic therapy including neoadjuvant or adjuvant che…
1.2mg given subcutaneously (SC) every 3 weeks, for a maximum of 35 cycles (2 years). Known HIV-positive participants will receive a weight-based dose of 6 µg/kg
1.25 mg/kg given intravenously (IV) on Day 1 and Day 8 of each 3-week cycle, for approximately 5.5 to 8 months (8 to 12 cycles), but no more than 12 cycles.
200 mg given intravenously (IV) every 3 weeks, for a maximum of 35 cycles (2 years)
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