A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Brain Cancer, Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/7/2018 |
Start Date: | November 2014 |
End Date: | October 2020 |
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a
dose-escalation assessment of the safety and tolerability of epacadostat administered with
nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate
the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in
subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer
(NSCLC).
Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN,
colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).
dose-escalation assessment of the safety and tolerability of epacadostat administered with
nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate
the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in
subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer
(NSCLC).
Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN,
colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).
Inclusion Criteria:
- Male or female subjects, age 18 years or older
- Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O
relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL
or HL, or glioblastoma
- Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for
B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of
measurable disease is not required.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of
the most recent prior chemotherapy regimen) are required for all cohorts except
glioblastoma
Exclusion Criteria:
- Laboratory and medical history parameters not within Protocol-defined range
- Currently pregnant or breastfeeding
- Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor
(except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL).
Subjects who have received experimental vaccines or other immune therapies should be
discussed with the medical monitor to confirm eligibility
- Untreated central nervous system (CNS) metastases or CNS metastases that have
progressed
- Subjects with any active or inactive autoimmune process
- Evidence of interstitial lung disease or active, noninfectious pneumonitis
- Subjects with any active or inactive autoimmune process
- Ocular MEL
We found this trial at
23
sites
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UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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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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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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