Immuno-oncology studies require some unique considerations. By ad­dressing these issues early in study de­sign, you can help avoid costly delays. Here are four you should prioritize.

• Selecting the right patients: The promise of targeted therapy requires precise identification of those patients likely to benefit from treatment, either by using commercially available assays or co-development of a companion diagnostic. A study design should ensure realistic accommodation for patient screening. Archival tissue may not be available, or even informative, in patients completing one or more cycles of chemotherapy. As the num­ber of candidates grow, finding treatment-naïve patients in classes such as checkpoint inhibitors is a growing challenge.
• Assigning the right dose: Choos­ing a treatment dose may not be straightforward. Many immuno­logic candidates are well-tolerated and a maximum tolerated dose may not be a realistic dose selec­tion strategy. Consider pharmaco­kinetic (PK) data to determine a clinically effective dose, a strategy that requires timing of assays and may often increase study costs, should samples require real-time versus batch processing.
• Choosing endpoints: While time-to-event endpoints are tracked, approvals are now often sought on surrogate endpoints, such as overall response rate and duration of response. Immuno-oncology studies introduce new challenges in establishing tumor response or disease progression.
• Managing safety: Infusion reac­tions, both in terms of patient safety and potential unblinding, must be considered. Sites and sponsors must be trained to rec­ognize and characterize immune-related adverse events which can be life-threatening.

Study designs that address precise identification of patients, determine a clinically effective dose, establish specific endpoints and manage safety will help speed your trial to a success­ful conclusion.

Written by Guest Writer Joy Yucaitis. Yucaitis is Senior Director, Oncology Strategy at Novella Clinical. She provides therapeutic and development consulting to oncology customers, strategic planning for new protocols and executive oversight for key projects. Yucaitis has more than 18 years of oncology drug and diagnostic development experience as both a sponsor and CRO director. For more information, visit novellaclinical.com/oncology.

This article was reprinted from Volume 24, Issue 03, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>