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: N/A
  • NCT ID: NCT03547973
  • Sponsor: Gilead Sciences

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 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

- * 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 UGT1A1 with no alternate option available. - * 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 Illinois Cancer Center
Chicago, Illinois 60612
United States
Status: Recruiting Contact: N/A
Facility: University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact: N/A
Facility: Southern Illinois University School of Medicine, Simmons Cancer Institute
Springfield, Illinois 62702
United States
Status: Recruiting Contact: N/A
Facility: Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
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: 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 Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz
Besançon, 25000
France
Status: Recruiting Contact: N/A
Facility: Hopital Saint Andre (CHU de Bordeaux)
Bordeaux, 33000
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Regional Universitaire Brest
Brest, 29200
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Departmental (CHD) Vendee
La Roche sur Yon, 85925
France
Status: Recruiting Contact: N/A
Facility: Centre Leon Berard
Lyon Cedex 08, 69373
France
Status: Recruiting Contact: N/A
Facility: Institut Paoli Calmettes
Marseille CEDEX 9, 13273
France
Status: Recruiting Contact: N/A
Facility: Centre Antoine Lacassagne
Nice, 06189
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau
Nîmes cedex, 30029
France
Status: Recruiting Contact: N/A
Facility: Hopital European Georges-Pompidou (HEGP)
Paris Cedex 15, 33000
France
Status: Recruiting Contact: N/A
Facility: Groupement Hospitalier Pitie-Salpetriere
Paris, 75013
France
Status: Recruiting Contact: N/A
Facility: Hopital Cochin
Paris, 75014
France
Status: Recruiting Contact: N/A
Facility: Centre Eugene Marquis
Rennes Cedex, 35042
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 de Cancerologie de Lorraine
Vandoeuvre les Nancy, 54519
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif, 94800
France
Status: Recruiting Contact: N/A
Facility: Urologicum Duisburg
Duisburg, 47179
Germany
Status: Recruiting Contact: N/A
Facility: Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt, 60389
Germany
Status: Recruiting Contact: N/A
Facility: Marien Hospital Herne
Herne, 44625
Germany
Status: Recruiting Contact: N/A
Facility: Institut für Versorgungsforschung in der Onkologie
Koblenz, 56068
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Tubingen, Klinik fur Urologie
Tübingen, 72076
Germany
Status: Recruiting Contact: N/A
Facility: Henry Dunant Hospital Center, 4th Oncology Department
Athens, 11526
Greece
Status: Recruiting Contact: N/A
Facility: University General Hospital of Ioannina, Oncology Department
Ioannina, 45500
Greece
Status: Recruiting Contact: N/A
Facility: Athens Medical Center, Oncology Department
Marousi, 15125
Greece
Status: Recruiting Contact: N/A
Facility: General Hospital of Patras Agios Andreas
Patra, 26335
Greece
Status: Recruiting Contact: N/A
Facility: Anassa General Clinic, Oncology-Chemotherapy Department
Volos, 38333
Greece
Status: Recruiting Contact: N/A
Facility: Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, 10408
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chonnam National University Hospital
Gwangju, 61469
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chonnam National University Hwasun Hospital
Hwasun, 519-763
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Korea University - Anam Hospital
Seongbuk-Gu,
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Yonsei University Health System, Severance Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: SMG-SNU Boramae Medical Center
Seoul, 07061
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, 5505
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: The Catholic University of Korea, St. Vincent's Hospital
Suwon-si, 16247
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Pusan National University Yangsan Hospital
Yangsan, 50612
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Hospital del Mar
Barcelona, 08003
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinic de Barcelona
Barcelona, 08023
Spain
Status: Recruiting Contact: N/A
Facility: CEIC Hospital Vall d'Hebron
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Reina Sofia
Cordoba, 14004
Spain
Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Centre
Madrid, 28033
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario La Paz
Madrid, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Puera de Hierro Majadahonda
Majadahonda, 28222
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Sant Joan de Deu
Manresa, 08243
Spain
Status: Recruiting Contact: N/A
Facility: Complejo Hospitalario de Ourense
Orense, 32005
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Marques de Valdecilla
Santander, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
Spain
Status: Recruiting Contact: N/A
Facility: Ankara Sehir Hastanesi
Ankara, 06550
Turkey
Status: Recruiting Contact: N/A
Facility: Dicle Universitesi Tip Fakultesi Hastanesi
Diyarbakir, 21280
Turkey
Status: Recruiting Contact: N/A
Facility: T.C. Saglik Bakanligi Goztepe Prof Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
Turkey
Status: Recruiting Contact: N/A
Facility: Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant
Izmir, 35575
Turkey
Status: Recruiting Contact: N/A
Facility: Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi
Seyhan, 01250
Turkey
Status: Recruiting Contact: N/A
Facility: University Hospitals Birmingham NHS Foundation Trust
Birmingham, B9 5SS
United Kingdom
Status: Recruiting Contact: N/A