Trial · NCT04724018
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination expansion cohort 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 safety assessment. | 21 days | Treatment-Related Adverse Events are assessed by CTCAE v5.0 when administering Sacituzumab Govitecan (SG) and Enfortumab Vedotin (EV) in combination. |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin and Pembrolizumab in combination progression-free survival. | 21 days | Assessed as progression-free survival per investigator assessment. |
| Secondary | Sacituzumab Govitecan (SG) and Enfortumab Vedotin and Pembrolizumab 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 and Pembrolizumab in combination safety assessment. | 21 days | Treatment-Related Adverse Events are assessed by CTCAE v5.0 when administering Sacituzumab Govitecan (SG) and Enfortumab Vedotin (EV) and Pembrolizumab in combination. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04724018/registered