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

NCT06682728 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 4473UCI 23-59
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urothelial Carcinoma; Muscle-invasive Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  To determine investigator-assessed disease-free survival (DFS) at 6 months.

  6 months after last patient enrollment

Secondary Outcomes (6)

• Secondary (1)

  Time from Cycle1 Day 1 of study treatment to first occurrence of a disease free survival event, up to 5 years.

• Secondary (2)

  Time from Cycle 1 Day 1 of study treatment to diagnosis of distant metastases or death from any cause, up to 5 years.

• Secondary (3)

  Time from C1D1 of study treatment to death of any cause, up to 5 years.

• Secondary (4)

  Up to 5 years

• Secondary (5)

  Conversion from positive ctDNA to negative at any point from baseline assessment, up to 5 years.

Study Arms (1)

Sacituzumab Govitecan PLUS Nivolumab

EXPERIMENTAL

Patients eligible for this study treatment will receive combination therapy with Sacituzumab Govitecan with Nivolumab for 4 cycles, followed by single-agent Nivolumab for an additional 11 cycles.

Drug: Sacituzumab Govitecan (SG); Drug: Nivolumab

Interventions

Sacituzumab Govitecan (SG) DRUG

Given IV

Sacituzumab Govitecan PLUS Nivolumab

Nivolumab DRUG

Given IV

Sacituzumab Govitecan PLUS Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (i.e. RC or nephroureterectomy), performed within 180 days prior to study treatment initiation.
• Radiographic disease-free status as determined by imaging within 28 days of C1D1 of study treatment.
• Prior platinum-based NAC is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \[10\]) or refuse platinum AC.
• 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 RC or nephroureterectomy surgical spec-imen.
• 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 RC or nephroureterectomy surgical speci-men.
• 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

You may not qualify if:

• Underwent a partial cystectomy or partial nephrectomy.
• History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy, including investigational agents, 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 (e.g. prednisone dose of ≥ 10 mg or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
• Inhaled or topical steroids are permitted in the absence of active autoimmune dis-ease.
• 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. Subjects must have complete wound healing and resolution from complications of major or minor surgery before 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, as defined in Section 4.1 above.
• Uncontrolled intercurrent illness including, but not limited to, the following conditions:
• Active and/or uncontrolled bacterial, viral, or fungal infection within 7 days of study treatment initiation.

Sponsors & Collaborators

• University of California, Irvine: lead
• Gilead Sciences: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

sacituzumab govitecan; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nataliya Mar, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 12, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)