RECRUITING

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2018-08-13

Study Completion:2030-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03547973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Female or male individuals, ≥ 18 years of age (19 Years old for South Korea). * Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1. * Adequate renal and hepatic function. * Adequate hematologic parameters without transfusional support. * Individuals must have a 3-month life expectancy. * 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 other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \> 12 months from completion of therapy. * 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 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified * No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \> 12 months since the last dose of systemic therapy. * Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma. * 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.	* 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 an active second malignancy. * Has known active Hepatitis B or Hepatitis C. * Has other concurrent medical or psychiatric conditions. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has an active second malignancy. * 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. * Cohort 3: Has received anti-PD-1/PD-L1 therapy previously. * Cohorts 3 to 6: 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. * Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product. * Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Have a Child-Pugh score of B or C. * Individuals with uncontrolled diabetes. * Have active keratitis or corneal ulcerations. * Participants with ongoing sensory or motor neuropathy Grade ≥ 2.

Inclusion Criteria

Exclusion Criteria

* Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
* Adequate renal and hepatic function.
* Adequate hematologic parameters without transfusional support.
* Individuals must have a 3-month life expectancy.
* 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 other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \> 12 months from completion of therapy.
* 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 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified
* No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \> 12 months since the last dose of systemic therapy.
* Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
* 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.

* 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 an active second malignancy.
* Has known active Hepatitis B or Hepatitis C.
* Has other concurrent medical or psychiatric conditions.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active second malignancy.
* 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.
* Cohort 3: Has received anti-PD-1/PD-L1 therapy previously.
* Cohorts 3 to 6: 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.
* Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product.
* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
* Have a Child-Pugh score of B or C.
* Individuals with uncontrolled diabetes.
* Have active keratitis or corneal ulcerations.
* Participants with ongoing sensory or motor neuropathy Grade ≥ 2.

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

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

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

The University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

University of California San Francisco

San Francisco, California, 94158

United States

Rocky Mountain Cancer Centers

Littleton, Colorado, 80120

United States

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06510

United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

United States

University of Illinois Cancer Center

Chicago, Illinois, 60612

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Southern Illinois University School of Medicine, Simmons Cancer Institute

Springfield, Illinois, 62702

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202

United States

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, 20613

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130

United States

Precision Cancer Research / New Mexico Oncology & Hematology Consultants

Albuquerque, New Mexico, 87109

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016

United States

Drug Shipping Address: New York-Presbyterian Hospital

New York, New York, 10065

United States

Stony Brook Cancer Center

Stony Brook, New York, 11794

United States

St. Luke's Hosptial - Bethlehem Campus

Easton, Pennsylvania, 18045

United States

Medical University of Southern Carolina

Charleston, South Carolina, 29425

United States

Thompson Oncology Group - Knoxville West

Knoxville, Tennessee, 37932

United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232

United States

Houston Methodist Hospital, Houston Methodist Cancer Center

Houston, Texas, 77030

United States

Mays Cancer Center

San Antonio, Texas, 78229

United States

Renovatio Clinical

The Woodlands, Texas, 77380

United States

University of Utah - Huntsman Cancer Hospital (IP Shipping Address)

Salt Lake City, Utah, 84112

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22903

United States

Virginia Oncology Associates

Hampton, Virginia, 23666

United States

Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Roanoke, Virginia, 24014

United States

Seattle Cancer Care Alliance

Seattle, Washington, 98109

United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-13

Study Completion Date2030-06

Study Record Updates

Study Start Date2018-08-13

Study Completion Date2030-06

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Urothelial Cancer