Ovarian Cancer Clinical Trial

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

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).

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Full Description

This clinical trial was initially intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2 prior to termination.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT02485990

Recruitment Status:

Terminated

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT02485990

Recruitment Status:

Terminated

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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