Clinical trial NCT02575807: Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Platinum-resistant Ovarian Cancer
Platinum-resistant Fallopian Cancer
Platinum-resistant Peritoneal Cancer
Keywords: Ovarian cancer
Fallopian cancer
Primary peritoneal cancer
Lead sponsor: Aduro Biotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2015-10-15
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2-part, Phase 1/2 study will test investigational cancer drugs known as CRS-207, epacadostat (IDO), and pembrolizumab (pembro). 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.


Eligibility 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

Primary outcomes:
measure: Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT)
timeFrame: Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207).
measure: Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher
timeFrame: Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months.
measure: Phase 2: Adverse Events (AEs)
timeFrame: Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months.
measure: Phase 2: Objective Response Rate (ORR)
timeFrame: BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks.
measure: Phase 2: Progression Free Survival (PFS)
timeFrame: Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks.
Secondary outcomes:
measure: Phase 1: Objective Response Rate (ORR) by mRECIST
timeFrame: BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 100 weeks.
measure: Phase 1: Progression Free Survival (PFS)
timeFrame: Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 100 weeks
measure: Disease Control Rate (DCR)
timeFrame: BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 100 weeks.
measure: Duration of Response (DOR)
timeFrame: Subjects followed for disease progression from date of CR or PR designation until documented disease progression or study termination, whichever comes first, assessed up to 100 weeks.
measure: Overall Survival (OS)
timeFrame: OS was assessed from the first dose of study treatment until death or study termination, whichever comes first, assessed up to 100 weeks.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Hospitals DBA HonorHealth
state: Arizona
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: CHUM - Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References: