Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer (NCT02257528) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
United States26 participantsStarted 2015-05-18
Plain-language summary
This phase II trial studies the side effects and how well nivolumab works in treating patients with cervical cancer that has grown, come back, or spread to other places in the body. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
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 persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix with documented disease progression (disease not amendable to curative therapy); NOTE: the following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma and mesonephric carcinoma; histologic confirmation of the original primary tumor is required via the pathology report
* All patents must have measurable disease as defined by RECIST 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 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 must have at least one "target" lesion" to be used to assess response on this protocol as defined by RECIST 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
* Appropriate for study entry based on the following diagnostic workup:
* History/physical examination within 28 days prior to registration
* Imaging of target lesion(s) w…
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 is a Phase 2 trial for persistent, recurrent, or metastatic cervical cancer — what does that phase mean for how much is known so far about whether nivolumab is safe and effective for my specific situation?
2The trial is 'active but no longer recruiting,' which means I can't join it — but can you tell me if the results from this study are available yet, and whether they might change the treatment options you'd recommend for me?
3Since this trial was measuring serious side effects — Grade 3 or higher — from nivolumab, what kinds of immune-related reactions should I know about if nivolumab or a similar checkpoint inhibitor is being considered as part of my care?
4My cancer type is listed as adenocarcinoma or adenosquamous carcinoma of the cervix — do you know if the results from this trial showed any differences in response based on the specific type of cervical cancer, and does that affect what you'd suggest for me?
5Given that this trial focused on tumor response using RECIST criteria, are there other immunotherapy trials or approved treatments targeting recurrent or metastatic cervical cancer that I might be eligible for now, and how would you compare them to what this study was testing?
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
Objective Tumor Response as Assessed by RECIST 1.1 Criteria
Timeframe: The average of study treatment time was 3.8 months.
2
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Timeframe: Within 100 days of last protocol treatment