PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer (NCT02571725) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer
United States50 participantsStarted 2016-02-23
Plain-language summary
Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair double-stranded breaks in DNA. Treating these tumors with poly(adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitors results in the specific killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of ovarian cancer patients with PARP inhibitors has resulted in improved progression free survival (PFS), but not overall survival (OS). It's not completely understood why this is the case, but some preclinical studies using ovarian cancer models in mice have suggested that combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors improves long-term survival.
Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma for which standard curative measures do not exist.
* Patients must have a confirmed germline mutation in the BRCA1 or BRCA2 gene
* Patients must have measurable disease as defined by World Health Organization (WHO) criteria: at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be \>1.0cm when measured by CT, MRI, or caliper measurement by clinical exam; or \>2.0cm when measured by chest x-ray. Lymph nodes must be \>1.5cm in short axis when measured by CT or MRI
* Patients with platinum-sensitive or platinum-resistant disease are eligible
* Patients must have received at least 1 prior course of platinum-based chemotherapy for the management of primary disease including carboplatin, cisplatin, or another platinum compound
* There are no restrictions on the total number of prior regimens patients may have received
* Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
* Adequate organ and marrow function as defined below:
* Absolute neutrophil count (ANC) \>1,500/mcl
* Platelets \> 100,000/mcl
* Creatinine \< 1.5x the institutional upper limit of normal (ULN)
* Bilirubin \< 1.5x ULN
* Aspartate aminotransferase and Alanine aminotransferase \< 3x ULN
* Alkaline phosphatase \< 2.5x ULN
* Women of child-bearing potential must have a negative pregnancy test prior to s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Recommended Phase 2 Dose (RP2D)
Timeframe: Within 56 days of first treatment (up to 2 years)