Trial · NCT06161532
Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C...
NCT06161532, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C... Trials, record NCT06161532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06161532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C...
- NCT number
- NCT06161532
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Small Cell Carcinoma of the Bladder, Small Cell Carcinoma of the Urinary Tract, Squamous Cell Carcinoma of the Bladder, Squamous Cell Carcinoma of the Urinary Tract, Primary Adenocarcinoma of the Bladder, Primary Adenocarcinoma of the Urinary Tract, Renal Medullary Carcinoma, Squamous Cell Carcinoma of the Penis
- Interventions
- Sacituzumab govitecan, Atezolizumab
- First posted
- 2023-12-08
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | On days 1 and 8 of each cycle and at every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD. | Percentage of participants by best overall response (e.g., CR, PR, SD, PD) to therapy |
| Secondary | Duration of response (DoR) | On days 1 and 8 of each cycle and at every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD. | Time from start of treatment to disease progression or death in participants who achieve CR or PR |
| Secondary | Overall survival (OS) | Days 1 and 8 of each cycle, at EoT, at the Safety visit, at follow-up, and every 90 days for up to a total of 5 years after the end of therapy | Time from the start of treatment that participants are still alive. |
| Secondary | Progression-free survival (PFS) | At every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD | Duration of time from start of treatment to time of progression or death, whichever occurs first |
| Secondary | Clinical benefit rate (CBR) | At every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD | Percentage of participant who have achieved CR, PR, and SD while on treatment. |
| Secondary | Safety of sacituzumab govitecan with or without atezolizumab | From first dose through 30 days after last treatment | Adverse events (AEs) will be reported by type and grade of toxicity |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40548513 | 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/NCT06161532
GET https://conductscience.org/api/trials/v1/NCT06161532/registered