Trial · NCT04724018
Sacituzumab Govitecan Plus EV in Metastatic UC
NCT04724018, Phase 1, Phase 2, Recruiting, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sacituzumab Govitecan Plus EV in Metastatic UC. Trials, record NCT04724018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04724018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sacituzumab Govitecan Plus EV in Metastatic UC
- NCT number
- NCT04724018
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 106 participants, estimated
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Urothelial Cancer, Metastatic Urothelial Carcinoma, Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter, Bladder Cancer
- Interventions
- Sacituzumab Govitecan (SG), Enfortumab vedotin-ejfv (EV), Pembrolizumab
- First posted
- 2021-01-26
- Last updated
- 2025-11-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) in Combination | 21 days | The Maximum Tolerated Dose (MTD) in mg of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) in Combination is assessed. |
| Primary | Dose-limiting toxicity (DLT) of Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination | 21 days | Treatment-Related Adverse Events are assessed by CTCAE v5.0 when administering Sacituzumab Govitecan (SG) and Enfortumab Vedotin (EV) in combination. |
| Primary | Efficacy of Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination | 21 days | Study SG + EV combination to further refine the recommended dose and to assess the ORR (unconfirmed CR or PR) per RECIST Version 1.1 as determined by investigator for the combination of EV and SG in combination in patients with mUC progressing on platinum-based chemotherapy and PD1/L1 inhibitors. |
| Primary | Efficacy of Sacituzumab Govitecan (SG) and Enfortumab Vedotin and Pembrolizumab in combination | 21 days | Study SG + EV + Pembrolizumab in combination to assess the ORR (unconfirmed CR or PR) per RECIST Version 1.1 as determined by investigator for the combination therapy of Pembrolizumab in combination with EV and SG in treatment-naïve patients with mUC. |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination objective response rate (ORR) | 21 days | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination rate of complete responses (CR) | 21 days | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination rate of partial responses (PR) | 21 days | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination rate of participants with progressive disease | 21 days | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination overall survival (OS) Rate | 21 days | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination expansion cohort progression-free survival. | 21 days | Assessed as progression-free survival per investigator assessment. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37871703 | DERIVED |
Source PubMed
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/NCT04724018
GET https://conductscience.org/api/trials/v1/NCT04724018/registered