Clinical Trials /

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

NCT02485990

Description:

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).

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)
  • Official Title: An Open Label Dose Escalation/Expansion Study of Tremelimumab Alone or Combined With Olaparib for Recurrent or Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

Clinical Trial IDs

  • ORG STUDY ID: J15113
  • SECONDARY ID: IRB00064379
  • NCT ID: NCT02485990

Conditions

  • Primary Peritoneal Carcinoma

Interventions

DrugSynonymsArms
TremelimumabArm A: Tremelimumab Alone
OlaparibLYNPARZAArm B1: DESE Tremelimumab and Olaparib

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).

Trial Arms

NameTypeDescriptionInterventions
Arm A: Tremelimumab AloneExperimental25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression.
  • Tremelimumab
Arm B1: DESE Tremelimumab and OlaparibExperimental18 patients will receive tremelimumab (3 or 10 mg/kg IV) every 4 weeks for 7 doses then every 12 weeks and olaparib (150 or 300 mg orally twice a day) until disease progression.
  • Tremelimumab
  • Olaparib
Arm B2: Tremelimumab and OlaparibExperimental25 patients will receive tremelimumab (every 4 weeks for 7 doses then every 12 weeks) and olaparib (daily) until disease progression. Dose of tremelimumab and olaparib will be determined during the DESE (Arm B1).
  • Tremelimumab
  • Olaparib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety as measured by the rate of AEs, serious AEs, deaths and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4)
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Fallopian Tube
  • Epithelial Ovarian
  • EOC

Last Updated

September 19, 2019