A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma
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Keep this study
Lead
Incyte Corporation
With
Hoffmann-La Roche
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma
