Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer
NCT ID: NCT02575807
Last Updated: 2019-04-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2016-03-08
2018-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: CRS-207
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 colony forming units \[CFU\]) administered by intravenous (IV) infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
CRS-207
via IV infusion
Phase 1: CRS-207/IDO 100 mg
CRS-207 administered in 3-week cycles, IDO administered twice daily (BID).
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 milligrams \[mg\]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle.
CRS-207
via IV infusion
Epacadostat
PO BID
Phase 1: CRS-207/IDO 300 mg
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
CRS-207
via IV infusion
Epacadostat
PO BID
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembrolizumab (pembro) administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
CRS-207
via IV infusion
Epacadostat
PO BID
Pembrolizumab
via IV infusion
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
CRS-207
via IV infusion
Pembrolizumab
via IV infusion
Interventions
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CRS-207
via IV infusion
Epacadostat
PO BID
Pembrolizumab
via IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Phase 1: Individuals with epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinomas who are considered to have platinum-resistant disease (progression within 6 months from completion of platinum-based chemotherapy).
* Phase 2: Individuals with epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinomas who are considered to have platinum-resistant disease (progression within 6 months from completion of a minimum of 4 platinum therapy cycles).
2. Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
3. Agree to provide core biopsies at baseline and at Cycle 2 Day 15
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Available archived tumor tissue for central analysis
6. Adequate organ and marrow function
Exclusion Criteria
2. Major surgical procedure within 4 weeks prior to Study Day 1
3. Inaccessible tumors or for whom biopsy is contraindicated
4. Clinically significant ascites
5. Phase 2 only: Previous treatment with \>3 chemotherapy regimens for locally advanced or metastatic disease
6. Active bowel obstruction, or hospitalization for bowel obstruction within 2 months prior to screening
7. Require parenteral nutrition
8. Hospitalization within 2 weeks prior to screening
9. Received any anticancer medication or therapy in the 21 days prior to study Day 1
10. Prior monoclonal antibody treatment within 4 weeks before study Day 1
11. History of listeriosis or previous treatment with a listeria-based immunotherapy
12. Known allergy to both penicillin and sulfa antibiotics
13. Any immunodeficiency disease or immune-compromised state
14. Received prior immune checkpoint inhibitors (e.g., anti-CTLA-4, anti-PD-1, anti PDL-1) and any other antibody or drug specifically targeting T-cell costimulation or an IDO inhibitor
15. Pregnant or breastfeeding
16. Clinically significant heart disease
17. Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
18. History of any autoimmune disease which required systemic therapy in the past 2 years
19. Diagnosed with another malignancy within the past 3 years
20. Currently receiving therapy with a UDP-glucuronosyltransferase 1A9 inhibitor including diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
21. Receiving monoamine oxidase inhibitor (MAOIs) or a drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within the 21 days before screening
22. Had prior serotonin syndrome
23. Has implanted medical devices that pose high risks for colonization and cannot be easily removed
18 Years
FEMALE
No
Sponsors
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Incyte Corporation
INDUSTRY
Aduro Biotech, Inc.
INDUSTRY
Responsible Party
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Locations
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CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States
Stanford Cancer Center
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ADU-CL-11
Identifier Type: -
Identifier Source: org_study_id
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