If you decide to take part in this study, you will be randomized in a 2:1 fashion to get chemotherapy plus a drug called nivolumab for 6 months or chemotherapy alone for up to 6 months.
2:1 means means twice as many patients will receive chemotherapy plus nivolumab as receive chemotherapy alone.
If you receive chemotherapy alone (carboplatin/paclitaxel), you will complete up to 6 months of treatment.
If you receive chemotherapy plus nivolumab, you will receive nivolumab every 2 weeks for the first month, and up to 6 months of chemotherapy. After the first month, you will receive nivolumab once a month (maintenance) for up to 2 additional years (if tolerating well and if there is no evidence of tumor growth).until your cancer gets worse or up to 2 years.
After you finish treatment on either arm, your doctor will continue to follow your condition for up to 2 years.
After you stop receiving the study treatment, you will visit the clinic once every 3 months for the first year, then every 6 months for the second year.
To monitor your safety and health while on study:
This study will also collect blood prior to therapy and up to four times during your treatment to look for changes in HPV ctDNA (circulating tumor DNA) that might help us better understand how your anal cancer is responding to therapy.
The most common side effects of nivolumab are fatigue, rash, muscle and joint aches, anemia, reduction in your thyroid function. Less common side effects include inflammation of your colon (colitis) and your lungs (pneumonitis).
The most common side effects of the chemotherapy may including reducing your blood counts, allergic reaction, mouth sores, gastrointestinal disorders (diarrhea, nausea, and vomiting), numbness of your fingertips, and hair loss.
Your oncology care team will be following you on a regular basis prior to each cycle to ensure these side effects are not negatively impacting your care or quality of life.