Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capiva… (NCT03660826) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone
United States, Canada288 participantsStarted 2018-09-27
Plain-language summary
This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.
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 or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell and carcinosarcoma histology is excluded.
* Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or non-measurable (detectable) disease
* Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \> 15 mm in short axis when measured by CT or MRI; patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
* Non-measurable (detectable) disease in a…
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.
1This trial is testing four different drug combinations — olaparib plus durvalumab, cediranib plus durvalumab, olaparib plus capivasertib, and cediranib alone — so which of these arms, if any, might be most relevant to my specific type of endometrial cancer, and how would that assignment work?
2Since this is a Phase 2 trial focused on progression-free survival, what does that mean in terms of how much is already known about whether these combinations actually extend life, and how does that compare to what standard second-line treatments can offer me right now?
3The trial is active but no longer recruiting new patients, so does that mean there's any realistic way for me to access these drug combinations — for example through compassionate use, expanded access, or a different open trial — if you think one of them could be a good fit for my situation?
4Given that my cancer has already come back or stopped responding to earlier treatment, how would you weigh the potential benefits of an experimental combination like olaparib with capivasertib against the side effect profiles of stacking two targeted agents together?
5Does the genetic profile or subtype of my tumor — for instance whether it's serous, endometrioid, or has a specific mutation — matter when it comes to deciding whether any of the combinations being studied in this trial would be worth pursuing?
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
Progression-free Survival
Timeframe: Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).