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

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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.


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
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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55 Fruit Street
Boston, Massachusetts 02114
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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