Study on Nivolumab for Treating Persistent, Recurrent, or Metastatic Cervical Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02257528
This clinical trial is testing the effectiveness and safety of nivolumab, a type of immunotherapy, in treating cervical cancer that has persisted, returned, or spread to other parts of the body. Nivolumab works by targeting specific cells to block tumor growth.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate how well nivolumab, an immunotherapy drug, works in treating cervical cancer that has not responded to previous treatments, has come back, or has spread. The study will also look at the side effects of nivolumab and how long patients live without the cancer getting worse.
Description
This study aims to see how effective nivolumab is in shrinking tumors in patients with persistent, recurrent, or metastatic cervical cancer. Researchers will also monitor the side effects of the drug. Patients will receive nivolumab through an IV every two weeks for up to 92 weeks, unless the cancer progresses or side effects become too severe. After treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.
The study will also explore how the immune system interacts with the cancer and how this affects treatment outcomes. Researchers will look at specific markers in the cancer and immune cells to understand their role in the treatment's effectiveness. Additionally, the study will examine the presence of certain viruses and cancer cells in the blood before and after treatment to see how they relate to patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Have cervical cancer that is persistent, has come back, or has spread, and cannot be cured with surgery.
- Have at least one tumor that can be measured by scans or physical exams.
- Have had one previous chemotherapy treatment for cervical cancer.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood cell counts and organ function as determined by specific blood tests.
- Be willing to provide a tumor sample and agree to follow study procedures.
- Women of childbearing potential must agree to use effective contraception during the study and for 23 weeks after the last dose of nivolumab.
Exclusion Criteria
- Have previously received nivolumab or similar immunotherapy drugs.
- Have a history of severe allergic reactions to monoclonal antibodies.
- Have another invasive cancer unless disease-free for at least three years.
- Have uncontrolled health conditions, such as active infections or heart problems.
- Be pregnant or breastfeeding, or not willing to use contraception if of childbearing potential.
- Have untreated or unstable brain metastases.
- Have a history of autoimmune diseases that require treatment with immunosuppressive drugs.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Require systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days of starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
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