Checkmate 914


Protocolnummer:

Ziekenhuizen:
Erasmus Medisch Centrum Rotterdam
Isala Zwolle

Titel:
Een gerandomiseerde dubbel geblindeerde fase 3 studie met nivolumab en ipilimumab vs placebo bij hoogrisico patiënten met heldercellig niercelcarcinoom na een radicale of partiële nefrectomie. Patienten krijgen gedurende een half jaar nivolumab (12x2-wekelijks) en ipilimumab (4kuren 6-wekelijks) of placebo in dezelfde frequentie.

Behandeling:
nivolumab en ipilimumab vs placebo bij hoogrisico patiënten

Stadium:

Belangrijkste in/exclusiecriteria:

Inclusiecriteria:

o Adults (≥ 18 years old) male and female subjects

o ECOG 0-1

oKidney tumour has been completely resected, and the nephrectomy must occur no less than 4 weeks and ≤ 12 weeks prior to randomization. Partial nephrectomy is allowed provided all inclusion criteria are met and negative surgical margins are obtained.

oPost-nephrectomy tumour shows RCC with a predominantly clear cell histology, including participants with sarcomatoid features.

oPathological TNM staging per AJCC staging version 2010:

§pT2a, G3 or G4, N0M0

§pT2b, G any, N0M0

§pT3, G any, N0M0

§pT4, G any, N0M0

§pT any, G any, N1M0

oParticipants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases (M0) after nephrectomy. Baseline tumor assessment, performed 4 to approximately 12 weeks after nephrectomy, shows no metastasis or residual tumor lesions per local review and as confirmed by BICR. Results of BICR of the baseline tumor assessment confirming absence of metastasis or residual tumor lesions must be received before randomization.

oEither a FFPE tissue block or unstained tumour tissue sections, obtained within 3 months prior to enrolment, preferably from nephrectomy, with an associated pathology report, must be submitted to the central laboratory prior to randomization. FFPE block or 20 unstained slides is ideal, but a minimum of 10 unstained slides will be acceptable if tumour tissue is limited. Biopsy should be excisional, incisional, or core needle. Fine needle aspiration is unacceptable for submission. Sites will be notified if there is insufficient tissue for analysis by the central lab.

Contactpersoon:
Dr. M. Tascilar, Isala

Alle niercelcarcinoom trials