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Trial record 1 of 1 for:    NCT02575807
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Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer (SEASCAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02575807
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This 2-part, Phase 1/2 study will test investigational cancer drugs known as CRS-207, epacadostat, and pembrolizumab. The purpose of this study is to find out how safe it is to give the investigational drugs to women with platinum-resistant ovarian, fallopian tube, or peritoneal cancer and if it helps patients with these types of cancer live longer or can help shrink or slow the growth of cancer.

Condition or disease Intervention/treatment Phase
Platinum-resistant Ovarian Cancer Platinum-resistant Fallopian Cancer Platinum-resistant Peritoneal Cancer Biological: CRS-207 Drug: Epacadostat Biological: Pembrolizumab Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label Safety and Efficacy Evaluation of CRS-207 in Combination With Epacadostat in Adults With Platinum-Resistant Ovarian, Fallopian, or Peritoneal Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Phase 1 Arm 1 CRS-207/Epacadostat
CRS-207: 1×10^9 CFU by IV infusion over 1 hour Epacadostat: 100 or 300 mg Oral BID
Biological: CRS-207
via IV infusion
Other Name: Live-attenuated double-deleted (LADD) Listeria monocytogenes
Drug: Epacadostat
PO BID
Other Names:
  • INCB024360
  • IDO
Experimental: Phase 1 Arm 2 CRS-207
CRS-207: 1×10^9 CFU by IV infusion over 1 hour
Biological: CRS-207
via IV infusion
Other Name: Live-attenuated double-deleted (LADD) Listeria monocytogenes
Experimental: Phase 2 Arm 1 CRS-207/Pembrolizumab
Pembrolizumab: 200 mg by IV infusion over 30 minutes CRS-207: 1×10^9 CFU by IV infusion over 1 hour
Biological: CRS-207
via IV infusion
Other Name: Live-attenuated double-deleted (LADD) Listeria monocytogenes
Biological: Pembrolizumab
via IV infusion
Other Name: Keytruda®
Experimental: Phase 2 Arm 2 CRS-207/Pembro/Epacadostat
Pembrolizumab: 200 mg by IV infusion over 30 minutes CRS-207: 1×10^9 CFU by IV infusion over 1 hour Epacadostat: 300 mg Oral BID
Biological: CRS-207
via IV infusion
Other Name: Live-attenuated double-deleted (LADD) Listeria monocytogenes
Drug: Epacadostat
PO BID
Other Names:
  • INCB024360
  • IDO
Biological: Pembrolizumab
via IV infusion
Other Name: Keytruda®


Outcome Measures

Primary Outcome Measures :
  1. Phase 1: Number of patients reporting hematologic and non-hematologic DLTs [ Time Frame: Through study completion, approximately 12 months ]
    DLT=dose-limiting toxicities

  2. Phase 1 and Phase 2: Adverse events by CTCAE grade [ Time Frame: Through study completion and safety follow up, approximately 24 months ]
    CTCAE=common terminology criteria for adverse events

  3. Phase 2: ORR will be measured, defined as CR or PR as determined by mRECIST [ Time Frame: approximately 24 months from initiation of Phase 2 ]
    ORR=overall response rate, CR=complete response, PR=partial response, mRECIST=modified response evaluation criteria in solid tumors

  4. Phase 2: PFS will be measured, defined as the time from the date of first dose to PD or death due to any cause [ Time Frame: approximately 24 months from initiation of Phase 2 ]
    PFS=progression-free survival, PD=disease progression


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Histologically-confirmed disease

    • 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

  1. Platinum-refractory disease (progression during the first platinum-based chemotherapy)
  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
Contacts and Locations

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): NCT02575807


Locations
United States, Arizona
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States, 85258
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
Aduro Biotech, Inc.
Incyte Corporation
More Information

Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02575807     History of Changes
Other Study ID Numbers: ADU-CL-11
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aduro Biotech, Inc.:
Ovarian cancer
Fallopian cancer
Primary peritoneal cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Pembrolizumab
Antineoplastic Agents