"The SPICI study is a randomized phase 3 [trial] asking the question of de-escalation," says Laurence Albiges, MD, PhD.
In this video, Laurence Albiges, MD, PhD, discusses the ongoing phase 3 SPICI-GETUG R05 trial (NCT05219318), exploring the noninferiority of a treatment pause vs treatment continuation of first-line immune checkpoint inhibitor plus a VEGFR-tyrosine kinase inhibitor in patients with metastatic renal cell carcinoma. Albiges is a medical oncologist and chair of the medical oncology department at Gustave Roussy Institute in Villejuif, France.
The background around this SPICI study is that as of 2024, for patients with advanced metastatic renal cell carcinoma, we are all using combination therapy. Among those patients, some of them will have more slowly growing disease, and those patients are captured by the IMDC classification [of] what we call IMDC good prognosis patient. Those patients are clearly well responding to the combination, they have long progression-free survival and long overall survival. One question in those patients is, can we de-escalate? Do we really need a combination for a long time or not? The SPICI study is a randomized phase 3 [trial] asking the question of de-escalation. This study is enrolling right now patients with IMDC good risk disease, meaning no adverse prognosis features, or intermediate with only 1 risk factor. We do know that those patients have a good prognosis, and they will live for several years. The question is, in those patients treated with a combination of 1 immune checkpoint plus 1 VEGFR-TKI, can we de-escalate?
The study is randomizing patients who were able to achieve either partial or complete response at the 12 months mark. At this time, treatment is being stopped. The randomization is sustained treatment, or discontinuous systemic therapy. Those patients with greater response could actually have the benefit of treatment break. We do know that from the TKI era, with the STAR trial that was conducted in the UK. So, overall, 370 patients will be randomized in the study; that is ongoing. The primary end point is the percentage of patients [that] have not relapsed, have not progressed 12 months after randomization. The study is currently open in France and will open in other countries, and hopefully will help to address the question of de-escalation in IMDC good risk patients.
This transcription has been edited for clarity.