J15117 - Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects with Virus-Positive and Virus-Negative Solid Tumors
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being conducted to determine the safety and effectiveness of nivolumab on virus positive and virus negative solid tumors. This research will be done with 2 cohorts. The first cohort will be in the neoadjuvant setting before surgery or chemotherapy + radiation. The second cohort involves metastatic disease or disease spread to other areas of the body outside of the original tumor site. Both cohorts will be investigating the use of nivolumab – a programmed cell death inhibitor (PD-1) of immune regulatory T-Cells. The first cohort will focus on squamous cancer of the head & neck (SCCHN) that are HPV positive and negative, polyomavirus associated Merkel cell carcinoma, and HPV positive cervical, vaginal, or vulvar cancers. The second cohort will focus on Epstein-Barr related gastric cancer and nasopharyngeal cancer, HPV positive SCCHN, HPV positive cervical, vaginal, or vulvar cancers, and polyomavirus associated merkel cell cancer.Nivolumab is approved by the FDA for the use in metastatic melanoma and non-small cell lung cancer. It is not approved for the cancer types investigated in this study.
Both cohorts:No active spread to brain and if brain spread – must have been treated greater than 4 weeks prior to start of study with MRI confirmation of stability. No systemic use of steroids greater than 10mg of prednisone per day. No prior cancer within 3 years except those with local spread that have been deemed cured such as basal cell carcinoma. No autoimmune diseases or sites of primary tumors fixed to the carotid artery, skull base, or cervical spine. No prior therapies with vaccines, checkpoint inhibitors, or drugs specifically targeting the regulatory T cell. No Hepatitis B, Hepatitis C, HIV positive, or AIDS diagnosis. Not currently pregnant.All subjects must have a good performance status, tumors available to be biopsied, and good organ functioning as determined by lab work.
The 1st cohort will receive two doses of nivolumab 2 weeks apart. This cohort will go on to get surgery and/or chemotherapy + radiation after the two doses of nivolumab are given.The 2nd cohort will receive nivolumab every 2 weeks for a time frame to be determined by disease progression, tolerance, or investigator decision.
12/09/2019 05:03 AM