Nivolumab for Advanced Cervical Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial requires that any prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents, and immunologic agents, must be stopped at least three weeks before joining. Investigational agents must be stopped for at least 30 days before joining. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Nivolumab for advanced cervical cancer?
Research shows that Nivolumab, an immune checkpoint inhibitor, had a disease control rate of 68.4% in a phase II study for advanced cervical cancer. Additionally, a separate study found that Nivolumab had an objective response rate of 25% in patients with cervical cancer, with better responses in those with PD-L1-positive tumors.12345
Is nivolumab safe for treating advanced cervical cancer?
How is the drug Nivolumab unique in treating advanced cervical cancer?
Nivolumab is unique because it is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, offering a new option for patients with advanced cervical cancer who have limited treatment choices after standard therapies. It works by blocking the PD-1/PD-L1 pathway, which cancer cells use to hide from the immune system, and has shown promising results in clinical trials for patients with recurrent or metastatic cervical cancer.34589
What is the purpose of this trial?
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.
Research Team
Alessandro D Santin
Principal Investigator
NRG Oncology
Eligibility Criteria
This trial is for patients with persistent, recurrent, or metastatic cervical cancer. Participants must have completed prior treatments and recovered from their effects, have measurable disease as per RECIST 1.1 criteria, and a performance status of 0 or 1. They should not be pregnant or nursing and agree to use contraception. Exclusions include brain metastases under certain conditions, HIV/AIDS, active hepatitis infection, autoimmune diseases requiring treatment, previous nivolumab therapy or similar drugs targeting immune pathways.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab intravenously every 2 weeks for a maximum of 46 doses over 92 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator