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)
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/13/2017 |
Start Date: | November 2014 |
End Date: | November 8, 2017 |
A Phase 1 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 (ECHO-110)
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 cell lung cancer (NSCLC) that have been previously treated with platinum-based
chemotherapy and Stage IV urothelial carcinoma who have failed a platinum-based chemotherapy
regimen. The study will be conducted in two phases. The dose escalation phase will utilize a
3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose
(PAD) of the combination. This will be followed by a dose expansion phase, which will be
comprised of three cohorts. Expansion Cohorts 1 & 2 will further evaluate the safety,
tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in
phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following
treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab
administered in combination.
in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) that have been previously treated with platinum-based
chemotherapy and Stage IV urothelial carcinoma who have failed a platinum-based chemotherapy
regimen. The study will be conducted in two phases. The dose escalation phase will utilize a
3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose
(PAD) of the combination. This will be followed by a dose expansion phase, which will be
comprised of three cohorts. Expansion Cohorts 1 & 2 will further evaluate the safety,
tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in
phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following
treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab
administered in combination.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
6
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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