Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

• Status: Terminated
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: AstraZeneca; MedImmune LLC
• Treatments: Antibodies, Monoclonal; Olaparib; Tremelimumab

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