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

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03547973
Protocol IDs
IMMU-132-06 - TROPHY U-01 (primary)
NCI-2018-03421
Study Sponsor
Gilead

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).

Objectives

Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5 and 6. Cohort 5 has been
cancelled, effective December 2023.

Eligibility

  1. Female or male individuals, = 18 years of age (19 Years old for South Korea).
  2. Individuals with histologically confirmed urothelial cancer (UC).
  3. Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
  4. Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
  5. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
  6. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression =12 months following completion of therapy.
  7. 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.
  8. 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.
  9. 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.
  10. 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).
  11. Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
  12. 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.
  13. No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).
  14. Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
  15. 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.
  16. 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.
  17. Cohorts 1, 2, 3 and 5: Creatinine clearance = 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified
  18. Adequate renal and hepatic function.
  19. Adequate hematologic parameters without transfusional support.
  20. Individuals must have a 3-month life expectancy.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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