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).
Age ≥ 18 years old.
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).
No prior systemic treatment for locally advanced/mUC.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Symptomatic or untreated central nervous system (CNS) metastases. Note: Participants with previously treated brain or CNS metastases are eligible if the participant have recovered from any acute effects of surgery or radiotherapy and do not require steroids (prednisone equivalent ≥ 10 mg daily), and any whole brain radiation therapy or any stereotactic radiosurgery was completed at least 2 weeks prior to initiation of therapy.
History of active autoimmune disease and on active management with immunosuppressive agents within the past 2 years.
History of interstitial lung disease.
Congestive heart failure (New York Heart Association class III or IV)
Single group
Nogapendekin Alfa Inbakicept (NAI)
Drug1.2mg 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
enfortumab vedotin (EV)
Drug1.25 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.
Pembrolizumab
Drug200 mg given intravenously (IV) every 3 weeks, for a maximum of 35 cycles (2 years)
Assess the safety and tolerability of the treatment regimen (NAI, EV, and pembrolizumab).
The proportion of participants with treatment-emergent adverse events (TEAEs), as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
12-month progression-free survival (PFS) of participants with locally advanced or metastatic urothelial carcinoma (mUC) receiving EV plus pembrolizumab and NAI
Percentage of participants alive and progression free at 12 months, defined as the time from the date of first dose of study drugs (C1D1) to the date of disease progression or death (any cause), whichever occurs first, by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
To evaluate the preliminary efficacy of the treatment regimen (EV, pembrolizumab, and NAI)
To evaluate the preliminary efficacy of the treatment regimen (EV, pembrolizumab, and NAI) as measured by complete response rate (CRR), objective response rate (ORR), clinical benefit rate (CBR), 12-month overall survival (12-OS), median duration of response (mDOR), median progression free survival (mPFS) and median overall survival (mOS).
To evaluate PFS, ORR, DOR, and CBR using immune RECIST (iRECIST).
PFS will be defined as the time from the date of first dose of study drugs (C1D1) to the date of disease progression or death (any cause), by RECIST v1.1 whichever occurs first. ORR is defined as the portion of participants who experience an objective response (confirmed CR or confirmed PR) per RECIST v1.1. DOR will be defined as the time from the first date of documented response (confirmed CR or confirmed PR) to the date of disease progression or death (any cause), by RECIST v1.1 whichever occurs first. CBR is defined as the portion of participants who experience clinical benefit (confirmed CR, confirmed PR, or SD for at least 24 weeks) per RECIST v1.1.
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