Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Nataliya Mar (uci)

Description

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.

Official Title

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

Keywords

Urothelial Carcinoma, Muscle-invasive Bladder Cancer, UC, muscle-invasive urothelial carcinoma, MIBC, sacituzumab govitecan, nivolumab, Carcinoma, Transitional Cell Carcinoma, Recurrence, Sacituzumab Govitecan (SG), Sacituzumab Govitecan PLUS Nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

within 180 days prior to study treatment initiation.

  • 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.

You CAN'T join if...

  • 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.

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Nataliya Mar (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 33 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06682728
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 23 study participants
Last Updated