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

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ClinicalTrials.gov Identifier: NCT02485990
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
AstraZeneca
MedImmune LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Primary Peritoneal Carcinoma Drug: Tremelimumab Drug: Olaparib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 4, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Tremelimumab Alone
25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression.
 Drug: Tremelimumab
Experimental: Arm B1: DESE Tremelimumab and Olaparib
18 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.
 Drug: Tremelimumab
Drug: Olaparib
Other Name: LYNPARZA
Experimental: Arm B2: Tremelimumab and Olaparib
25 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).
 Drug: Tremelimumab
Drug: Olaparib
Other Name: LYNPARZA


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT02485990


Contacts
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Contact: Maureen Berg, RN 443-287-6602 mberg1@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Maureen Berg, RN    443-287-6602    mberg1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
AstraZeneca
MedImmune LLC
Investigators
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Principal Investigator: Leisha Emens, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02485990     History of Changes
Other Study ID Numbers: J15113
IRB00064379 ( Other Identifier: JHM IRB )
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Fallopian Tube
Epithelial Ovarian
EOC

Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Olaparib
Tremelimumab
Antibodies, Monoclonal
 Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs