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 range18 Years
SexFEMALE
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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…
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