RECRUITING

Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence

Conditions

Urothelial Carcinoma Muscle-invasive Bladder Cancer UC muscle-invasive urothelial carcinoma MIBC sacituzumab govitecan nivolumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.

Official Title

Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence

Quick Facts

Study Start:2024-11-15

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06682728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years at the time of study consent. * ECOG Performance Status of 0, 1 or 2 (see Appendix A). * Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed. * Underwent curative-intent surgery, including radical cystectomy or nephroureterectomy. * Radiographic disease-free status as determined by imaging within 28 days of C1 D1 of study treatment. * Prior platinum-based neoadjuvant chemotherapy (NAC) is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \[10\]) or refuse platinum adjuvant chemotherapy. * Prior treatment with neoadjuvant investigational agents is allowed (except PD-1/PD-L1 inhibitors) or Sacituzumab Govitecan. No washout from neoadjuvant therapy is required. * If NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T2, T3, T4, or N+ disease on the radical cystectomy or nephroureterectomy surgical specimen. * If no NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T3, T4, or N+ disease on the radical cystectomy or nephroureterectomy surgical specimen. * Adequate organ and marrow function as defined below: * ANC ≥ 1000/mcL * Platelets ≥ 100,000/mcL * Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 3.0 × ULN for subjects with Gilbert's disease) * AST/ALT ≤ 3 × institutional ULN * Alkaline phosphatase ≤ 3 × institutional ULN * Serum albumin ≥ 2.8 g/dL * Creatinine Creatinine clearance of ≥30 mL/min (calculated with Cockroft- Gault formula) * Hemoglobin ≥ 9.0 g/dL * aPTT ≤ 1.3 × institutional ULN * Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception. * Female subjects of childbearing potential must not be pregnant following signing the study consent form. * Recovery to ≤ Grade 1 of CTCAE version 5 toxicities related to any prior treatment for UC, unless AE(s) is clinically non-significant and/or stable on supportive therapy as per discretion of the Investigator. * Ability to understand and the willingness to sign a written informed consent.	* Underwent a partial cystectomy or partial nephrectomy. * History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy following surgical removal of UC. * History of treatment with PD-1/PD-L1 inhibitors or Sacituzumab Govitecan prior to study treatment initiation. * History of previous radiation therapy for treatment of UC. * Radiographic evidence of metastasis. * Receipt of or planning to receive any other concurrent investigational agents. * History of active, known, or suspected autoimmune disease. * Conditions requiring treatment with either systemic high-dose corticosteroids or other immunosuppressive medications within 14 days of study treatment initiation. * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Major surgery within 28 days or minor surgery within 14 days before the first dose of study treatment. * Active malignancy within 3 years of study entry, except treated localized non- melanoma skin cancer, Gleason 6 prostate cancer on active surveillance, or curatively treated in situ cancer of the breast or cervix. * Patients who do not have adequate organ and marrow function. * Uncontrolled intercurrent illness. * Received a live vaccine within 30 days prior to the first dose of study treatment. * Known or suspected severe hypersensitivity (Grade ≥ 3) to Nivolumab, Sacituzumab Govitecan, Irinotecan, and/or any of their components.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years at the time of study consent.
* ECOG Performance Status of 0, 1 or 2 (see Appendix A).
* Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed.
* Underwent curative-intent surgery, including radical cystectomy or nephroureterectomy.
* Radiographic disease-free status as determined by imaging within 28 days of C1 D1 of study treatment.
* Prior platinum-based neoadjuvant chemotherapy (NAC) is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \[10\]) or refuse platinum adjuvant chemotherapy.
* Prior treatment with neoadjuvant investigational agents is allowed (except PD-1/PD-L1 inhibitors) or Sacituzumab Govitecan. No washout from neoadjuvant therapy is required.
* If NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T2, T3, T4, or N+ disease on the radical cystectomy or nephroureterectomy surgical specimen.
* If no NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T3, T4, or N+ disease on the radical cystectomy or nephroureterectomy surgical specimen.
* Adequate organ and marrow function as defined below:
* ANC ≥ 1000/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 3.0 × ULN for subjects with Gilbert's disease)
* AST/ALT ≤ 3 × institutional ULN
* Alkaline phosphatase ≤ 3 × institutional ULN
* Serum albumin ≥ 2.8 g/dL
* Creatinine Creatinine clearance of ≥30 mL/min (calculated with Cockroft- Gault formula)
* Hemoglobin ≥ 9.0 g/dL
* aPTT ≤ 1.3 × institutional ULN
* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
* Female subjects of childbearing potential must not be pregnant following signing the study consent form.
* Recovery to ≤ Grade 1 of CTCAE version 5 toxicities related to any prior treatment for UC, unless AE(s) is clinically non-significant and/or stable on supportive therapy as per discretion of the Investigator.
* Ability to understand and the willingness to sign a written informed consent.

* Underwent a partial cystectomy or partial nephrectomy.
* History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy following surgical removal of UC.
* History of treatment with PD-1/PD-L1 inhibitors or Sacituzumab Govitecan prior to study treatment initiation.
* History of previous radiation therapy for treatment of UC.
* Radiographic evidence of metastasis.
* Receipt of or planning to receive any other concurrent investigational agents.
* History of active, known, or suspected autoimmune disease.
* Conditions requiring treatment with either systemic high-dose corticosteroids or other immunosuppressive medications within 14 days of study treatment initiation.
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
* Major surgery within 28 days or minor surgery within 14 days before the first dose of study treatment.
* Active malignancy within 3 years of study entry, except treated localized non- melanoma skin cancer, Gleason 6 prostate cancer on active surveillance, or curatively treated in situ cancer of the breast or cervix.
* Patients who do not have adequate organ and marrow function.
* Uncontrolled intercurrent illness.
* Received a live vaccine within 30 days prior to the first dose of study treatment.
* Known or suspected severe hypersensitivity (Grade ≥ 3) to Nivolumab, Sacituzumab Govitecan, Irinotecan, and/or any of their components.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Nataliya Mar, MD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Nataliya Mar, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-15

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2024-11-15

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

UC
Urothelial Carcinoma
muscle-invasive urothelial carcinoma
MIBC
sacituzumab govitecan
nivolumab

Additional Relevant MeSH Terms

Urothelial Carcinoma
Muscle-invasive Bladder Cancer