Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer
Status:
Not yet recruiting
Trial end date:
2029-04-01
Target enrollment:
Participant gender:
Summary
The NESCIO-trial is a multicenter, randomized, open-label, three-arm phase II trial
investigating different combinations of neoadjuvant immunotherapy in patients with primary,
resectable, intermediate to high-risk, stage III clear-cell renal cell carcinoma. In this
trial patients will be randomized 1:1:1 to receive either 2 cycles of nivolumab 360mg every 3
weeks (arm A), 2 cycles of ipilimumab 1 mg/kg + nivolumab 3 mg/kg every 3 weeks (arm B) or 2
cycles of relatlimab 360mg + nivolumab 360mg every 3 weeks (arm C), prior to surgery at week
7.
After 42 patients (14 per arm) have been recruited, an interim analysis will be performed to
evaluate the observed efficacy and toxicity within each arm and either allow for early
discontinuation of the treatment or continuing recruitment for the second stage. As the
primary endpoint, the pathological response (decrease in tumor) will be evaluated. If at most
one pathologic response in the primary tumor is observed, the treatment arm will be closed
for insufficient activity on the primary tumor. If at least 2 pathologic responses are
observed, 9 additional patients will be included to a total of 23 patients per cohort. A
maximum of 69 patients will be recruited for this study.
Follow up will start at week 12 with a CT-scan according to the national/center's standard.
Patients will be evaluated every 3 months by physical examination and lab testing for up to
two years, thereafter according to institutional guidelines up to 5 years following surgery.