Today JAMA Oncology released a peer-reviewed manuscript first authored by Ravi B Parikh, MD, MPP, guiding the research and care of patients with advanced solid tumors who are traditionally ineligible for phase 3 clinical trials using immune checkpoint inhibiter therapy.

Immunotherapy is a type of cancer treatment which uses the body's natural defenses to fight cancer by improving the immune system's ability to attack cancer cells. Immune checkpoint inhibitors include medications that change the interactions between immune cells and cancer cells using certain molecules.

“This is the largest analysis to date to study uptake and overall survival outcomes following checkpoint inhibitor therapy in populations who are traditionally ineligible for clinical trials of immunotherapy, including patients with poor performance status and organ dysfunction,” explains Dr. Parikh.

The study shows that trial-ineligible patients preferentially receive immune checkpoint inhibitor therapy. However, in contrast to results from phase III clinical trials, researchers found no survival benefit to checkpoint inhibitors compared to other therapies among these vulnerable patients.

“These results suggest that results from phase III trials may not extend to trial-ineligible patients and provide a strong argument to ensure adequate representation of traditionally trial-ineligible populations in future clinical trials,” said Dr. Parikh. “Our hope is to use this preliminary data to justify a large multicenter prospective study of checkpoint inhibitor therapy among vulnerable patients with poor performance status or organ dysfunction.”

This is the fourth peer-reviewed manuscript linked to Dr. Parikh’s 2019 Conquer Cancer Young Investigator Award (YIA), which he was given to study real-world effectiveness of novel cancer drugs like immunotherapy. Dr. Parikh’s current research focuses on improving cancer care delivery, quality of life, and survivorship care among people with cancer using digital health and real-world data.