Trial · NCT07217496
N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer
NCT07217496, Phase 1, Not yet recruiting, ImmunityBio, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer. Trials, record NCT07217496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07217496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer
- NCT number
- NCT07217496
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, estimated
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Urothelial Cancer, Bladder Cancer
- Interventions
- Nogapendekin Alfa Inbakicept (NAI), enfortumab vedotin (EV), Pembrolizumab
- First posted
- 2025-10-16
- Last updated
- 2026-09-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the safety and tolerability of the treatment regimen (NAI, EV, and pembrolizumab). | From the date of first dose of study product to 30 days after the last dose of study product. | 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. |
| Primary | 12-month progression-free survival (PFS) of participants with locally advanced or metastatic urothelial carcinoma (mUC) receiving EV plus pembrolizumab and NAI | From the date of first dose of study drugs to the date of disease progression or death (any cause) | 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. |
| Secondary | To evaluate the preliminary efficacy of the treatment regimen (EV, pembrolizumab, and NAI) | 12 months | 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). |
| Secondary | To evaluate PFS, ORR, DOR, and CBR using immune RECIST (iRECIST). | From date of first dose of study drugs to the end of the follow up period, up to five years. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07217496
GET https://conductscience.org/api/trials/v1/NCT07217496/registered