Status:
TERMINATED
A Study of Atezolizumab (MPDL3280A) in Combination With Epacadostat (INCB024360) in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma (ECHO-110)
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
Hoffmann-La Roche
Genentech, Inc.
Conditions:
NSCLC (Non-small Cell Lung Carcinoma)
UC (Urothelial Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cel...
Eligibility Criteria
Inclusion
- Male or female subjects, age 18 years or older
- Histologically or cytologically confirmed NSCLC
- Stage IIIB or Stage IV NSCLC who are not candidates for multimodality treatment and have received at least 1 line of standard platinum-based therapy:
- Prior systemic regimens must include at least 2 cycles of a platinum-based therapy and may include platinum therapy used as a radiosensitizer. Maintenance chemotherapy is allowed.
- Tumors with driver mutations (epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive) should have had disease progression or been intolerant to the standard tyrosine-kinase inhibitor (TKI), and should include a second line TKI where such therapy is available and indicated.
- Subjects initially treated with a platinum regimen for Stage IIIB disease who later develop metastatic disease and are re-treated with a platinum regimen are allowed.
- Histologically or cytologically confirmed urothelial carcinoma.
- Stage IV locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Presence of measurable disease per RECIST v1.1
- Availability of an adequate archival tumor specimen or willingness to undergo a pretreatment tumor biopsy.
- Subjects enrolled in Expansion Cohort 3 must be willing to have 2 on-treatment tumor biopsies.
- For males and females of child-bearing potential, willingness to use adequate birth control through 90 days after the last dose of epacadostat or atezolizumab.
Exclusion
- Laboratory and medical history parameters not within protocol-defined range.
- Current treatment with an investigational study drug or immunological-based agent for any reason, or receipt of anticancer medication within 21 days or 5 half-lives (whichever is longer) before first dose.
- Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor.
- Prior monoclonal antibody within 4 weeks before study Day 1, or has not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Has an active or inactive autoimmune process.
- Has a history of pneumonitis or idiopathic pulmonary fibrosis, or evidence of interstitial lung disease.
- Prior radiotherapy within 2 weeks of therapy; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Untreated central nervous system (CNS) metastases or CNS metastases that have progressed after completion of radiotherapy.
- Use of systemic corticosteroids ≤ 2 weeks before Cycle 1 Day 1.
- Currently pregnant or breastfeeding.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2017
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02298153
Start Date
November 1 2014
End Date
November 8 2017
Last Update
December 11 2017
Active Locations (6)
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1
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
2
Yale University
New Haven, Connecticut, United States, 06510
3
Harvard-Mass General Hospital
Boston, Massachusetts, United States, 02114
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215