The first patient at the Sidney Kimmel Cancer Center at Jefferson Health recently began receiving treatment as part of a phase II clinical trial studying adjuvant nivolumab. It is a single arm study of nivolumab every 4 weeks for 12 cycles in patients with stage 2b/2c melanoma who have had their melanoma removed and a negative sentinel lymph node biopsy.
Nivolumab (Opdivo) is a PD-1 inhibitor currently FDA approved for stage 3 and 4 melanoma; however, the only treatment currently approved for stage 2 melanoma is interferon, which is very toxic. Nivolumab will offer a potentially much less toxic treatment to patients.
This investigator initiated trial is led by Adam Berger, MD, FACS, Chief of the Section of Surgical Oncology, Department of Surgery at Thomas Jefferson University Hospital, and Professor, Sidney Kimmel Medical College at Thomas Jefferson University.
“Stage 2b and 2c melanoma patients have an approximately 30 percent to 45 percent rate of recurrence, so our goal is to decrease this rate of recurrence by about 50 percent with this treatment. This is currently the only trial open in the U.S. for patients with stage 2 melanoma to receive a PD-1 inhibitor in the adjuvant setting,” Berger said.
Berger will be assessing the recurrence rate in patients at 24 months.
For more information on the clinical trial, visit https://clinicaltrials.gov/ct2/show/NCT03405155.