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

Stopped early · Phase 1

Conditions studied: Primary Peritoneal Carcinoma

In brief

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).

Key facts

Study ID

NCT02485990

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

24

Starts

2016-01-08

Expected to finish

2020-03-05

Last updated by the study team

2021-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form
• Age ≥ 18 years
• Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)
• Have archival tissue or willingness to undergo a tumor biopsy
• Have measurable disease
• Have had one prior taxane-platinum-based chemotherapeutic regimen
• 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
• Have received hormonal therapy
• ECOG Performance Status of 0 to 1
• Ability to take oral medications
• HIV, HTLV-1, HBV, and HCV negative
• Adequate organ and bone marrow function as defined by study-specified laboratory tests
• Normal blood coagulation parameters
• Life expectancy greater than 16 weeks
• Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
• Willing and able to comply with study procedures

You may not qualify if…

• Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor
• Active infection requiring antibiotics
• Active autoimmune disease
• Active and uncontrolled intercurrent illness
• History of other cancers within the past 5 years
• Systemically active steroid use
• Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug
• Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
• Requirement for chronic parenteral hydration/nutrition
• Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug
• Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy
• Patients with myelodysplastic syndrome/acute myeloid leukaemia
• History of diverticulitis
• History of bleeding disorder or diathesis.
• Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw
• Major surgical procedure within 28 days of study enrollment, or anticipated while on study.
• Pregnant or breast feeding woman

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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