NCT05148546

Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer

Prospective, Randomized, Neoadjuvant Phase II Study With Combination Immuno-oncology in Primary Clear Cell Renal Cancer at Risk for Recurrence or Distant Metastases (NESCIO-trial)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant nivolumab	Patients will receive 2 cycles of nivolumab 360mg (arm A and C) or 3mg/kg (arm B) every 3 weeks followed by a nephrectomy.
DRUG	Neoadjuvant ipilimumab	Patients will receive 2 cycles of ipilimumab 1mg/kg every 3 weeks followed by a nephrectomy.
DRUG	Neoadjuvant relatlimab	Patients will receive 2 cycles of relatlimab 360mg every 3 weeks followed by a nephrectomy.

Timeline

• Start date: 2022-04-28
• Primary completion: 2025-04-22
• Completion: 2029-04-01
• First posted: 2021-12-08
• Last updated: 2025-09-30

Locations

2 sites across 2 countries: Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study