Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT05535218
Brief Summary:
This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.
Patients will be consecutively enrolled and treated. All patients enrolled who receive at least 1 cycle of study drug will be included in the primary and secondary endpoint analyses.
Detailed Description:
The general framework of the study will be as follows:
A TURBT for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, computed tomography (CT) scan, 18FDG-PET/CT scan, and a pelvic MRI will be done during screening and before the surgical assessment to stage and evaluate response. The same imaging assessments will be performed after the neoadjuvant treatment. Patients with the evidence of no detectable disease after neoadjuvant therapy will also undergo a cystoscopy assessment prior to the reTURBT.
* Eligible patients will receive neoadjuvant treatment: 7.5 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle.
* Pembrolizumab will be administered in combination with sacituzumab govitecan on day 1, every 21 days, at the standard dose of 200 mg intravenously.
* A total of 4 cycles is planned before surgery.
* Patients who achieve a clinical complete response (cCR) will be offered a reTURBT instead of radical cystectomy. Patients not achieving a cCR will undergo a radical cystectomy.
* cCR will be defined as the achievement of ALL the following requirements: no evidence of residual disease (VIRADS 0 score) at MRI, negative cystoscopy, and a biopsy obtained via reTURBT revealing no residual viable cancer.
* Surgery will be planned at the time of study inclusion to be done ideally within 4 weeks of the last dose of study drug, and not later than 12 weeks from the last dose of study drug.
* After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab(neoadjuvant + adjuvant).
* After cystectomy or reTURBT, patients will undergo imagingassessments according to EAU guidelines. In patients undergoing reTURBT, cystoscopy assessments will be performed every 4 months for the first 2 years (until study conclusion),then according to investigator judgment.
* At the end of the adjuvant period, patients will enter the follow-up period which will lastuntil 12 months from the last dose of pembrolizumab.
Study:
NCT05535218
Study Brief:
Protocol Section:
NCT05535218