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Trial record 17 of 31 for:    "Transitional Cell Carcinoma" | "Atezolizumab"

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)

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ClinicalTrials.gov Identifier: NCT02298153
Recruitment Status : Terminated (Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.)
First Posted : November 21, 2014
Last Update Posted : December 11, 2017
Sponsor:
Collaborators:
Hoffmann-La Roche
Genentech, Inc.
Information provided by (Responsible Party):
Incyte Corporation

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 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.

Condition or disease Intervention/treatment Phase
NSCLC (Non-small Cell Lung Carcinoma) UC (Urothelial Cancer) Drug: atezolizumab Drug: epacadostat Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: atezolizumab (MPDL3280A) + epacadostat (INCB024360)
atezolizumab (MPDL3280A) 1200 mg given every 3 weeks + epacadostat (INCB024360) 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
Drug: atezolizumab
atezolizumab: administered intravenously (IV) every three weeks (q3w)
Other Name: MPDL3280A

Drug: epacadostat
epacadostat: Oral daily dosing
Other Name: INCB024360




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 months ]
  2. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days following the first administration of atezolizumab and epacadostat ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Measured every 6 weeks for duration of study participation [approximately 8 months] ]
    ORR determined by radiographic disease assessments per modified RECIST v1.1

  2. Durability of response [ Time Frame: Measured every 6 weeks for duration of study participation [approximately 8 months] ]
    Time from the earliest date of disease response until earliest date of disease progression based on modified RECIST v1.1

  3. Progression-free survival [ Time Frame: Measured every 6 weeks for duration of study participation [approximately 8 months] ]
    Time from date of enrollment until the earliest date of disease progression per modified RECIST v1.1 or death due to any cause, whichever is earlier.

  4. Duration of disease control [ Time Frame: Measured every 6 weeks for duration of study participation [approximately 8 months] ]
    Time from first dose until report of disease progression for subjects who reported stable disease or better based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298153


Locations
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United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Harvard-Mass General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Incyte Corporation
Hoffmann-La Roche
Genentech, Inc.
Investigators
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Study Director: Hiroomi Tada, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02298153     History of Changes
Other Study ID Numbers: INCB 24360-110 / ECHO-110
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Atezolizumab
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs