Trial · NCT06133517
PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer
NCT06133517, Phase 2, Active not recruiting, Fundación para el Progreso de la Oncología en Cantabria
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer. Trials, record NCT06133517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06133517
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer
- NCT number
- NCT06133517
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Fundación para el Progreso de la Oncología en Cantabria
- Conditions
- Urothelial Bladder Carcinoma
- Interventions
- Sacituzumab govitecan, Zimberelimab, Domvanalimab
- First posted
- 2023-11-15
- Last updated
- 2026-10-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the efficacy measured as pathologic complete response rates of the combo SG+ZIM+DOM in the perioperative setting in patients with MIBC who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy. | 42 months | Efficacy of the combination of sacituzumab govitecan, zimberelimab and domvanalimab measured as pathologic complete response (pCR) rates. pCR is defined as absence of residual viable tumor (ypT0) in the radical cystectomy specimen and in the resected lymph nodes (ypN0) (post-treatment). |
| Secondary | To evaluate the downstaging rate induced by the combo | 42 months | Downstaging is defined as any non-muscle invasive residual disease after treatment in the cystectomy specimen (i.e ypTis, ypTa,ypT1). |
| Secondary | To measure overall survival (OS) and disease-free survival (DFS) in the study population | 42 months | OS is defined as the time from informed consent signature to death from any cause. |
| Secondary | To evaluate the safety of the combo | 42 months | Safety and tolerability of the combination of sacituzumab govitecan, zimberelimab and domvanalimab measured as the incidence, nature and severity of adverse events (AEs). |
| Secondary | To identify predictive biomarkers associated with response to SG + ZIM + DOM. | 42 months | Cancer associated fibroblast (CAFs) as predictors of response. Immune sub-populations as predictors of response |
| Secondary | To gain knowledge about the role of ctDNA in the perioperative setting | 42 months | This parameter will be measured by ctDNA clearance, defined as the proportion of patients who are ctDNA positive at baseline and ctDNA negative after concluding the neoadjuvant component of the treatment, at the time of concluding neoadjuvant treatment and at the time post cystectomy. |
| Secondary | To explore the role of adjuvant ZIM+DOM in selected patients after definitive surgical treatment | 42 months | DFS event is defined as any of the following: development of distant metastasis of urothelial carcinoma or presence of pelvic recurrence of urothelial carcinoma (including soft tissue and regional lymph nodes) or death from any cause. OS is defined as the time from informed consent signature to death from any cause. |
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/NCT06133517
GET https://conductscience.org/api/trials/v1/NCT06133517/registered