Open
Actively Recruiting
Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer
About
Brief Summary
The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- Individuals with histologically documented metastatic or locally advanced unresectable
UC defined as
- Tumor (T) 4b, any node (N) or
- Any T, N 2-3 Tumors of upper and lower urinary tract are permitted. Mixed histologic types are allowed if urothelial is the predominant histology.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Individuals with progression or recurrence following receipt of platinum-containing
regimen and anti programmed cell death protein 1/programmed death-ligand 1
(PD-1/PD-L1) therapy for metastatic or locally advanced unresectable disease will be
enrolled.
- a. Individuals with recurrence or progression ≤12 months following completion of cisplatin-containing chemotherapy given in the neo-adjuvant/adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or platinum therapy, respectively. These individuals must receive anti PD-1/PD-L1 therapy in the metastatic or locally advanced unresectable setting to be eligible.
- b. Individuals who received either carboplatin or anti PD-1/PD-L1 therapy in the neo- adjuvant/adjuvant setting will not be able to count that line of therapy towards eligibility for the study.
- c. Cisplatin ineligible individuals who meet one of the below criteria and who
were treated with carboplatin in the metastatic or locally advanced unresectable
settings may count that line of therapy towards eligibility. They must then have
received anti PD-1/PD-L1 therapy in metastatic or locally advanced unresectable
setting to be eligible for the study.
- Cisplatin ineligibility is defined as meeting one of the following criteria:
-
- Creatinine Clearance < 60 mL/min
-
- Grade ≥ 2 Audiometric Hearing Loss
-
-
- Grade ≥ 2 Peripheral Neuropathy
- Cisplatin ineligibility is defined as meeting one of the following criteria:
-
- New York Heart Association (NYHA) Class III heart failure
-
- ECOG PS ≥ 2
Key Exclusion Criteria:
- Females who are pregnant or lactating.
- Have had a prior anti-cancer monoclonal antibody (mAb)/ antibody-drug conjugate (ADC) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible.
- Have received prior chemotherapy for UC with any available SOC therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an approved therapy, or prior paclitaxel, docetaxel and vinflunine in regions where vinflunine is approved and is commercially available).
- Have not recovered (i.e., ≤ Grade 1) from AEs due to previously administered
chemotherapeutic agent.
- Note: Individuals with ≤ Grade 2 neuropathy or any grade of alopecia are an exception to this criterion and will qualify for the study.
- Note: If Individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy.
- Have previously received topoisomerase 1 inhibitors.
- Have an active second malignancy.
- Note: Individuals with a history of malignancy that have been completely treated and with no evidence of active cancer for 3 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll in the study after discussion with the medical monitor.
- Have active cardiac disease, defined as:
- Myocardial infarction or unstable angina pectoris within 6 months of C1D1.
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
- NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of <40%.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
- Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
- Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.
- Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In individuals with a history of HBV or HCV, individuals with a detectable viral load will be excluded.
- Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab govitecan-hziy or unable or unwilling to receive the doses specified in the protocol.
- Have inability to complete all specified study procedures for any reason.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study Stats
Protocol No.
21-000703
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Ventura