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Urothelial CarcinomaPhase 2NCT06682728

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

A Phase 2 study testing Sacituzumab Govitecan (SG) and Nivolumab in people with Urothelial Carcinoma and Muscle-invasive Bladder Cancer, run by University of California, Irvine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Govitecan (SG) and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
15 Nov 2024to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Serum albumin ≥ 2.8 g/dL
  • Creatinine Creatinine clearance of ≥30 mL/min (calculated with Cockroft-Gault formula)
  • Hemoglobin ≥ 9.0 g/dL
  • aPTT ≤ 1.5 × institutional ULN
  • Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including male condom, female condom, or diaphragm with spermicidal gel, etc.) that are approved by the Investigator. Contra-ception must be used during the course of the treatment and for 6 months after the last dose of study treatment.
  • Female subjects of childbearing potential must not be pregnant following signing the study consent form. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal sta-tus (defined as at least 12 months of amenorrhea in a woman ≥ 45 years-of-age in the ab-sence of other biological or physiological causes).
  • Recovery to ≤ Grade 1 of CTCAE version 5 toxicities related to any prior treatment for UC, unless the AE(s) is clinically non-significant and/or stable on supportive therapy as per discretion of the Investigator.
  • Subjects with any type of genitourinary catheters (i.e. nephrostomy, Foley, etc) are al-lowed.
  • Ability to understand and the willingness to sign a written informed consent. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, hard of hearing, and illiterate individuals are eligible for this trial.

Who cannot join

  • 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.
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  • 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.
  • History of HIV infection with detectable viral load.
  • History of Hepatitis B or C infection with detectable viral load.
  • History of severe liver impairment (Child-Pugh C liver cirrhosis).
  • History of active tuberculosis (Bacillus tuberculosis).
  • Congestive heart failure New York Heart Association (NYHA) Class 3 or 4, unstable angina pectoris, or serious uncontrolled cardiac arrhythmias.
  • Stroke (including transient ischemic attack (TIA), myocardial infarction (MI), or other ischemic arterial event within 90 days before first dose of study treatment.
  • Severe, uncontrolled bleeding within 14 days before first dose of study treatment.
  • Uncontrolled diarrheal illness ≥ Grade 3 in severity within 14 days before first dose of study treatment.
  • History of inflammatory bowel disease (i.e. ulcerative colitis, Crohn's disease, etc.) or any other condition that puts patients at high risk of developing severe diarrhea.
  • Psychiatric illness/social situations causing inability to comply with study proce-dures or follow up.
  • Pregnancy at the time of or following study consent.
  • Breastfeeding at the time of or following study consent.
  • Received a live vaccine within 28 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.
  • History or current evidence of any condition, therapy, or laboratory/radiographic abnormal-ity that might confound the results of the study, interfere with the patient's ability to participate for the full duration of the study, or is not in the best interest of the patient to partici-pate in the study, in the opinion of the Investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chao Family Comprehensive Cancer Center University of California, Irvine contact

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical contact

United States1 site, 1 recruiting

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868

    Nataliya Mar, MD, 877-827-8839, ucstudy@uci.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Sacituzumab Govitecan (SG), Nivolumab
Keywords
UC, Urothelial Carcinoma, muscle-invasive urothelial carcinoma, MIBC, sacituzumab govitecan, nivolumab
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan (SG)Drug

    Given IV

  • NivolumabDrug

    Given IV

Study groups in NCT06682728
Study groupRoleWhat they receive
Sacituzumab Govitecan PLUS NivolumabExperimentalPatients 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.
Receives: Drug: Sacituzumab Govitecan (SG); Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Objective

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

    Measured: 6 months after last patient enrollment

Secondary outcomes (6)

  1. Secondary (1)

    To determine investigator-assessed DFS (i.e. time from Cycle 1 Day 1 (C1D1) of study treatment to first occurrence of a DFS event), defined as any of the following:

    1. Local (pelvic) recurrence of UC (including regional lymph nodes)
    2. Urinary tract recurrence of UC (including all pathological stages and grades)
    3. Distant metastasis of UC
    4. Death from any cause

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

  2. Secondary (2)

    To determine investigator-assessed distant metastasis-free survival (MFS) (i.e. time from Cycle 1 Day 1 of study treatment to diagnosis of distant metastases or death from any cause).

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

  3. Secondary (3)

    To determine overall survival (OS) (i.e. time from Cycle 1 Day 1 of study treatment to death of any cause).

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

  4. Secondary (4)

    To determine incidence of Grade 3 or higher AEs.

    Measured: Up to 5 years

  5. Secondary (5)

    To determine rate of ctDNA clearance in ctDNA positive patients (i.e. conversion from positive ctDNA to negative at any point from baseline assessment).

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

  6. Secondary (6)

    To perform exploratory biomarker analysis.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start15 Nov 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682728
Sponsor's protocol ID
4473
Other IDs
UCI 23-59
Status last verified
Apr 2026
First submitted
1 Nov 2024
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan (SG) and Nivolumab in people with Urothelial Carcinoma and Muscle-invasive Bladder Cancer, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective (time frame: 6 months after last patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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