The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

A phase 3 trial evaluating neoadjuvant with adjuvant nivolumab in patients with nonmetastatic renal cell carcinoma (RCC) has been initiated, according to a poster presentation at the ASCO20 Virtual Scientific Program.

Nephrectomy may remove immune effector cells and cytokines from the tumor site, which may result in a decreased immune response. Animal studies and early results from phase 2 trials suggest that neoadjuvant treatment with anti–PD-1 therapy may have antitumor efficacy. Moreover, neoadjuvant anti–PD-1/PD-L1 treatment in other cancer types has shown promise. The purpose of this trial is to evaluate the neoadjuvant and adjuvant approach with anti–PD-1 therapy in patients with nonmetastatic RCC.

The international, unblinded, phase 3 PROSPER RCC (ECOG-ACRIN EA8143) trial randomly assigned approximately 805 patients with nonmetastatic RCC to receive 1 dose of nivolumab prior to nephrectomy followed by an additional 9 adjuvant doses (480 mg every 4 weeks) or nephrectomy followed by standard-of-care surveillance.

All RCC histology is allowed, and patients must be scheduled to undergo partial or radical nephrectomy. Oligometastatic disease is allowed if no evidence of disease can be achieved by 12 weeks after nephrectomy. Oligometastatic disease is defined as metastases to 3 or more sites, none of which can be within the brain, bone, or liver. Histologic confirmation is required only for patients who will receive nivolumab, but is encouraged for all other patients.


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The primary endpoint is recurrence-free survival (RFS). Other endpoints include safety, tolerability, and quality of life.

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The sample size was selected to provide 84.2% power to detect an absolute benefit of 14.4% in recurrence-free survival (RFS) at 5 years. This was based on a historical RFS in the control arm of the ASSURE trial, which was 56% to 70%.

To date, 396 patients have been enrolled.

Research funding for this study was provided by US National Institutes of Health.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.

Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2020 meeting by visiting the conference page.

Reference

Haas NB, Puligandla M, Allaf ME, et al. PROSPER: Phase III randomized study comparing perioperative nivolumab versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN EA8143). Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr TPS5101.