Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy
Condition: Metastatic Urothelial Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03547973
Sponsor: Gilead Sciences
Phase: Phase 2
- Age: minimum 18 Years maximum N/A
- Gender: All
Key Inclusion Criteria:
- Participants 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.
- Cohorts 4 and 5: 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).
- Adequate renal and hepatic function.
- Adequate hematologic parameters without transfusional support.
- Individuals must have a 3-month life expectancy.
- Have measurable disease by Computed Tomography Imaging (CT) or Magnetic Resonance Imaging (MRI) as per RECIST 1.1 criteria.
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 (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- 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
- Cohorts 3 to 5: Has active autoimmune disease requiring systemic treatment with steroids or other immunosuppressive agent or any condition that in the Investigator's judgment precludes treatment with pembrolizumab, 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, has received anti-PD-1/PD-L1 therapy previously
- Cohorts 4 and 5: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant/adjuvant setting. Note: Other protocol defined Inclusion/
- may apply.
View trial on ClinicalTrials.gov