Skin Cancer: New Immunotherapies Expand Patients’ Options

By Asim Amin, MD

Just 20 years ago, malignant melanoma was almost universally fatal, with a median survival time of just six to nine months. Enter interleukin-2 (IL-2) therapy – the first immunotherapy that effectively harnessed the immune system’s potential, eliciting durable responses in patients to treat advanced melanoma.

IL-2 was a major breakthrough that allowed some patients to survive for more than 10 years after treatment, but it’s an intense therapy with serious side effects. Fortunately, the latest generation of immunotherapies – called checkpoint inhibitors – could be more effective, easier to tolerate and applied to a much broader group of patients.

These therapies manipulate “on” and “off” switches on T lymphocytes, enabling them to kill cancer cells. At Levine Cancer Institute (LCI), we’re using clinical trials to bring the latest checkpoint inhibitors to patients.

Checkpoint Inhibitors for Hard-to-Treat Skin Cancers

LCI played a key role in trials showing that some checkpoint inhibitors, like ipilimumab, nivolumab and pembrolizumab, are safe and effective in patients with melanoma – paving the way for these drugs to become standard care for some patients. Now we’re building on that progress by investigating newer checkpoint inhibitors to see if they can be effective against other, harder-to-treat skin cancers.

Our clinical trials include:

• A study that combines nivolumab with a new agent, relatlimab, for patients with refractory or relapsed melanoma. Relatlimab inhibits the LAG-3 checkpoint, potentially enabling T cells to attack melanoma cells in patients whose disease progresses after anti-PD-1/PD-L1 therapy.


• A Phase I trial investigating the maximum tolerable dose of AGEN1884 for patients with advanced melanoma and other cancers that are considered incurable. AGEN1884 blocks an antigen, called CTLA4, that inhibits T cells.


• A Phase III study of a PD-L1 inhibitor, avelumab, in combination with chemoradiotherapy as a front-line treatment for SCCHN. This study investigates whether this combination is more effective than standard chemoradiation.


• A Phase III study that combines ipilimumab and nivolumab as front-line treatment for patients with recurrent or metastatic SCCHN. This immunotherapy approach is a promising, less toxic alternative to the standard EXTREME regimen.


• A Phase I/II study of nivolumab, and nivolumab plus iplimumab, in patients with virus-associated cancers. The trial includes a neoadjuvant cohort that’s open to patients with Merkel cell carcinoma and HPV-positive and HPV-negative SCCHN. A separate cohort investigates these therapies in patients with metastatic or recurrent cancers including Merkel cell carcinoma and SCCHN.


• A Phase Ib/II trial of SD-101 in combination with pembrolizumab in patients with metastatic melanoma, or recurrent or metastatic SCCHN. SD-101 is a toll-like receptor 9 agonist delivered directly into tumors, where it can potentially induce interferon and recruit the immune system.

Immunotherapy Experts

LCI is home to the region’s oldest, most experienced immunotherapy program. This gives us the expertise to match your patient with the right clinical trial, and to make treatment as safe and effective as possible.

Our process starts with a multidisciplinary evaluation by medical oncologists, radiation oncologists and cancer surgeons. These specialists work together to develop a comprehensive care plan for each patient.

For questions, or to make a referral, call 980-442-3300.