A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

INTRODUCTION

  • Org Study ID: IMMU-132-06
  • Secondary ID: 2018-001167-23
  • NTC ID: NCT03547973
  • Sponsor: Gilead Sciences
Gilead Clinical Trials Website

BRIEF SUMMARY

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

DETAILED DESCRIPTION

Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5 and 6.

  • Overall Status
    Recruiting
  • Start Date
    August 13, 2018
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)

Primary Outcome 1 - Timeframe: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

Primary Outcome 2 - Measure: Progression free survival (PFS) based on central review by RECIST 1.1 criteria (Cohort 5 only)

Primary Outcome 2 - Timeframe: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

CONDITION

  • Metastatic Urothelial Cancer

ELIGIBILITY

Key Inclusion Criteria:
Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).

- Individuals with histologically confirmed urothelial cancer (UC).

- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;

- Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.

- Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy.

- Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease.

- Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.

- Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg/m^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m^2 Day 1 and Day 8 of every 21-day cycle).

- Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin.
No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).

- Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.

- Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or >12 months from completion of adjuvant therapy are permitted.

- Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

- Cohorts 5 and 6: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified

- Adequate renal and hepatic function.

- Adequate hematologic parameters without transfusional support.

- Individuals must have a 3-month life expectancy.
Key Exclusion Criteria:
Females who are pregnant or lactating.

- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (ie, ≤Grade 1 from AEs due to a previously administered agent).

- For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade < 2 adverse events not constituting a safety risk based on the investigator's judgment are acceptable. - Requires concomitant medication interfering with ABCA1 transporter or UGT1A1 - Has an active second malignancy. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has known active Hepatitis B or Hepatitis C. - Has other concurrent medical or psychiatric conditions. - Cohort 3: Has received anti-PD-1/PD-L1 therapy previously. - Cohorts 3 to 5: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. - Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose of study drug(s), has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis. - Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant/adjuvant setting. - Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free interval >12 months between the last treatment administration and the date of recurrence is required.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Gilead Study Director

Role: Study Director

Affiliation: Gilead Sciences

Overall Contact

Name: Gilead Study Director

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

LOCATION

Facility Status Contact
Facility: The University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Status: Recruiting Contact: N/A
Facility: University of California San Francisco
San Francisco, California 94158
United States
Status: Recruiting Contact: N/A
Facility: Rocky Mountain Cancer Centers
Littleton, Colorado 80120
United States
Status: Recruiting Contact: N/A
Facility: Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut 06510
United States
Status: Recruiting Contact: N/A
Facility: Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut 06360
United States
Status: Recruiting Contact: N/A
Facility: Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
Status: Recruiting Contact: N/A
Facility: Woodlands Medical Specialists, PA
Pensacola, Florida 32503
United States
Status: Recruiting Contact: N/A
Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: N/A
Facility: University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact: N/A
Facility: Norton Cancer Institute, Downtown
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: N/A
Facility: Maryland Oncology Hematology, P.A.
Brandywine, Maryland 20613
United States
Status: Recruiting Contact: N/A
Facility: University of Michigan
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: N/A
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact: N/A
Facility: Precision Cancer Research / New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico 87109
United States
Status: Recruiting Contact: N/A
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact: N/A
Facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Status: Recruiting Contact: N/A
Facility: Drug Shipping Address: New York-Presbyterian Hospital
New York, New York 10065
United States
Status: Recruiting Contact: N/A
Facility: Stony Brook Cancer Center
Stony Brook, New York 11794
United States
Status: Recruiting Contact: N/A
Facility: St. Luke's Hosptial - Bethlehem Campus
Easton, Pennsylvania 18045
United States
Status: Recruiting Contact: N/A
Facility: Medical University of Southern Carolina
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: N/A
Facility: Thompson Oncology Group - Knoxville West
Knoxville, Tennessee 37932
United States
Status: Recruiting Contact: N/A
Facility: Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: N/A
Facility: Houston Methodist Hospital, Houston Methodist Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: Mays Cancer Center
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: University of Utah - Huntsman Cancer Hospital (IP Shipping Address)
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: N/A
Facility: University of Virginia Cancer Center
Charlottesville, Virginia 22903
United States
Status: Recruiting Contact: N/A
Facility: Virginia Oncology Associates
Hampton, Virginia 23666
United States
Status: Recruiting Contact: N/A
Facility: Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia 24014
United States
Status: Recruiting Contact: N/A
Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: N/A
Facility: University of Wisconsin Clinical Science Center
Madison, Wisconsin 53705
United States
Status: Recruiting Contact: N/A
Facility: Centre Leon Berard
Lyon Cedex 08, 69373
France
Status: Recruiting Contact: N/A
Facility: Hopital Cochin
Paris, 75014
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Prive Saint-Gregoire
Rennes, 35000
France
Status: Recruiting Contact: N/A
Facility: Hospitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, 67200
France
Status: Recruiting Contact: N/A
Facility: Hospital Foch
Suresnes, 92150
France
Status: Recruiting Contact: N/A
Facility: Institut Claudius Regaud
Toulouse Cedex 9, 31059
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif, 94800
France
Status: Recruiting Contact: N/A