Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment … (NCT03914612) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
United States, Canada, Japan813 participantsStarted 2019-08-22
Plain-language summary
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this 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:
* Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
* Pathology report showing results of institutional MMR IHC testing.
* Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.).
* Submission of tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration.
* In patients with measurable disease, lesions will be defined and monitored by RECIST version (v) 1.1. 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 CT or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI.
* Patients may have received
* NO prior chemotherapy for treatment of endometrial cancer OR
* Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy \[with or without cisplatin\]) provided adjuvant chemotherapy was completed \>= 12 months prior to STEP 2 regi…
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 in Phase 3 and is actively enrolling patients — but it says 'active, not recruiting' — does that mean enrollment is closed, and if so, are there other similar trials comparing pembrolizumab plus chemotherapy for my stage of endometrial cancer that I could still join?
2Since the trial is measuring progression-free survival as its main goal, what does that actually mean for my situation — how does delaying cancer progression compare to looking at overall survival, and is that a meaningful benefit for my specific type of endometrial cancer?
3My tumor type is listed among the conditions this trial covers — but does the specific subtype I have, such as serous or clear cell, respond differently to adding pembrolizumab to paclitaxel and carboplatin, and does that affect whether this approach makes sense for me?
4Pembrolizumab is an immunotherapy drug — what kinds of immune-related side effects should I be aware of on top of the usual chemotherapy side effects from paclitaxel and carboplatin, and how are those managed if they occur?
5Given that my cancer is Stage III or IV or recurrent, would you recommend starting with standard chemotherapy first, or is there a strong reason to consider an approach that includes immunotherapy like pembrolizumab right from the beginning?
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 (PFS)
Timeframe: Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months.