What to Know About the Phase 2 ARCITECT Trial in ccRCC

Michael Serzan, MD, genitourinary medical oncologist at Dana-Farber Cancer Institute and an instructor of medicine at Harvard Medical School, discusses what a community oncologist should know about the phase 2 ARCITECT (NCT05928806) trial for patients with clear cell renal cell carcinoma (ccRCC).

ARCITECT is a randomized, open label, multicenter, phase 2 trial in which invetsiagtors are assessing the safety and efficacy of botensilimab (AGEN1181) relative to ipilimumab (Yervoy) and nivolumab (Opdivo) for treatment naive patients with metastatic ccRCC.

A total of 120 patients are planned to be enrolled in the study. Once enrolled, patients will be randomly assigned 2:1 to either arm A or arm B of the study. Those in arm A will receive the combination of botensilimab and balstilimab (AGEN2034) while those in arm B will be given ipilimumab in combination with nivolumab. Both arms will continue to receive treatment until toxicity, disease progression, or a maximum of 96 total weeks.

The primary end point of the study is objective response rate. Secondary end points include duration of response for patients who have a complete response or a partial response, the 12- & 24-month landmark progression-free survival, treatment free survival, and safety.

Transcription

0:09 | For the community oncologist, I would want them to know that there is potentially a new, more effective treatment option available for patients with clear cell kidney cancer that is really seeking to build on the success of previous immunotherapy combinations. It is available at 12 sites around the country. So certainly referring patients to those tertiary care centers so that they may be considered for this trial.

0:34 | I think also for patients with clear cell kidney cancer, we really need to be thoughtful about what is the best treatment to give patients at upfront and if there are any discussions or uncertainty about the best treatment option that seeking a second opinion is always encouraged just to ensure that patients are having access to the latest trials that are available.