Baltimore, Maryland 21231


Purpose:

This study will be looking at what dose of tremelimumab and olaparib is safe and effective in patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma).


Criteria:

Inclusion Criteria: 1. Signed informed consent form 2. Age ≥ 18 years 3. Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma) 4. Have archival tissue or willingness to undergo a tumor biopsy 5. Have measurable disease 6. Have had one prior taxane-platinum-based chemotherapeutic regimen 7. Have had a treatment-free interval following platinum-based therapy of less than 12 months, have progressed during platinum-based therapy, or had persistent disease after a platinum-based regimen 8. Have received hormonal therapy 9. ECOG Performance Status of 0 to 1 10. Ability to take oral medications 11. HIV, HTLV-1, HBV, and HCV negative 12. Adequate organ and bone marrow function as defined by study-specified laboratory tests 13. Normal blood coagulation parameters 14. Life expectancy greater than 16 weeks 15. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug 16. Willing and able to comply with study procedures Exclusion Criteria: 1. Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor 2. Active infection requiring antibiotics 3. Active autoimmune disease 4. Active and uncontrolled intercurrent illness 5. History of other cancers within the past 5 years 6. Systemically active steroid use 7. Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug 8. Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir 9. Requirement for chronic parenteral hydration/nutrition 10. Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug 11. Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy 12. Patients with myelodysplastic syndrome/acute myeloid leukaemia 13. History of diverticulitis 14. History of bleeding disorder or diathesis. 15. Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw 16. Major surgical procedure within 28 days of study enrollment, or anticipated while on study. 17. Pregnant or breast feeding woman


NCT ID:

NCT02485990


Primary Contact:

Principal Investigator
Leisha Emens, MD
Sidney Kimmel Comprehensive Cancer Center

Maureen Berg, RN
Phone: 443-287-6602
Email: mberg1@jhmi.edu


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States

Maureen Berg, RN
Phone: 443-287-6602
Email: mberg1@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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