Recruitment is ongoing for a phase 3 trial that will evaluate nivolumab plus ipilimumab vs nivolumab and placebo among patients with localized renal cell carcinoma (RCC) at risk of relapse after a radical or partial nephrectomy, according to a poster presented at the 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020),

“Many patients with stage II or III tumors have a high risk of relapse after surgery and reducing the risk with adjuvant therapies is an important goal,” Axel Bex, MD, PhD, of the Netherlands Cancer Institute in the Netherlands, and presenter of the study, said. “Several clinical trials have investigated adjuvant treatments for RCC, but outcomes thus far remain suboptimal.”

“The combination of nivolumab plus ipilimumab has shown impressive antitumor activity in treatment-naive patients with advanced renal cell carcinoma, suggesting that this combination might also provide benefits in the adjuvant setting, at earlier stages,” Dr Bex added.

The international, double-blind, multicenter CheckMate 914 study “now has been adapted to now incorporate a nivolumab monotherapy arm,” according to Dr Bex. The phase 3 trial has a target enrollment of 1600 patients from North and South America, Europe, Asia, and Australia. Patients are eligible if they have localized RCC with predominantly clear cell histology — with sarcomatoid features allowed — who are at high risk of relapse after a partial or radical nephrectomy. There must be no clinical and radiologic evidence of microscopic residual disease or distant metastases after nephrectomy.


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The trial consists of 2 parts — part A and part B. The trial was modified to include part B due to the efficacy of nivolumab monotherapy in the advanced RCC setting.

In part A, patients will be randomly assigned in a 1:1 ratio to receive nivolumab plus ipilimumab or placebo. The primary endpoint will be disease-free survival (DFS) of the combination compared with placebo. The secondary endpoints will include overall survival (OS), and safety and tolerability.

In part B, patients will be randomly assigned in a 1:1:2 ratio to receive nivolumab plus ipilimumab, placebo, or nivolumab monotherapy. The primary endpoint will be DFS between nivolumab monotherapy and placebo. The secondary endpoints will include OS between nivolumab and placebo, and DFS and OS between nivolumab monotherapy and the combination regimen — as well as safety and tolerability.

Disclosure: The study discussed in the abstract was supported by Bristol Myers Squibb. For a full list of disclosures, please refer to the original abstract.

Reference

Bex A, Russo P, Tomita Y, et al. A phase 3, randomized, placebo-controlled trial of nivolumab or nivolumab plus ipilimumab in patients with localized renal cell carcinoma at high risk of relapse after radical or partial nephrectomy (CheckMate 914). Presented at: 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020); November 6-7, 2020. Abstract TIP135.

This article originally appeared on Cancer Therapy Advisor