Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Neoplasm Metastasis

Carcinoma

Recurrence

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Ipilimumab

Relatlimab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Neoadjuvant 2 cycles of nivolumab 360mg every 3 weeks

Neoadjuvant 2 cycles of nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks

Neoadjuvant 2 cycles of nivolumab 360mg + relatlimab 360mg every 3 weeks

Patients will receive 2 cycles of nivolumab 360mg (arm A and C) or 3mg/kg (arm B) every 3 weeks followed by a nephrectomy.

Neoadjuvant nivolumab

Patients will receive 2 cycles of ipilimumab 1mg/kg every 3 weeks followed by a nephrectomy.

Neoadjuvant ipilimumab

Patients will receive 2 cycles of relatlimab 360mg every 3 weeks followed by a nephrectomy.

Neoadjuvant relatlimab

John Haanen, Prof

Femke Burgers, MD

Axel Bex, Prof

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.

Open-label three-arm randomized phase II trial

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)

Pathologic response rate is defined as the proportion of patients demonstrating a complete pathologic or partial pathologic response, according to central revision (pathology of NKI)

ORR is defined as the proportion of patients demonstrating a complete or partial response according to RECIST 1.1

RFS is defined as the time from randomization to recurrence or death from any cause, whichever occurs first. Subjects last known to be alive, who have not experience recurrence, will be censored.

EFS is defined as the time from randomization to recurrence, distant metastasis, or death from any cause, whichever occurs first. Subjects who are event-free at the end of follow-up will be censored.

The proportion of patients starting treatment who experience distant metastases during follow-up.

The proportion of patients starting treatment who experience a local recurrence during follow-up.

Surgical complication rates according to Clavien-Dindo classification

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer	NCT05148546	Renal Cell Carc...	Neoadjuvant niv... Neoadjuvant ipi... Neoadjuvant rel...	18 Years -	The Netherlands Cancer Institute
Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer	NCT05148546	Renal Cell Carc...	Neoadjuvant niv... Neoadjuvant ipi... Neoadjuvant rel...	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for neoadjuvant ipilimumab