Preoperative ipilimumab plus nivolumab in locoregionally advanced urothelial cancer (NABUCCO Cohort 1)

Study ID Alternative Stable ID Type
EGAS00001004521 Other

Study Description

Preoperative immunotherapy with anti-PD1 plus anti-CTLA4 antibodies has shown remarkable pathological responses in melanoma1 and colorectal cancer2. In NABUCCO ( NCT03387761), a single-arm feasibility trial, twenty-four stage III urothelial cancer patients received 2 doses of ipilimumab and 2 doses of nivolumab, followed by resection. The primary endpoint was feasibility to resect <12 weeks from treatment start. All patients were evaluable for the study endpoints and underwent resection; twenty-three (96%) within <12 weeks. Grade 3-4 immune-related adverse events occurred in 55% of patients; 41% when excluding clinically insignificant laboratory abnormalities. 46% of patients had a pathological complete response (pCR), meeting the secondary efficacy endpoint. Fourteen patients (58%) had no remaining invasive disease (pCR or pTisN0/pTaN0). In contrast to studies with anti-PD1/PD-L1 monotherapy, complete response to ipilimumab plus nivolumab was independent of baseline CD8+ presence or T-effector signatures. Induction of TLS upon treatment was observed in ... (Show More)

Study Datasets 1 dataset.

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Dataset ID Description Technology Samples
NABUCCO cohort 1 sequencing data. The dataset includes: * Whole exome DNAseq pre-treatment on tumor samples (n=24) matched with blood samples (n=24) * RNAseq pre-treatment on tumor samples (n=18) * RNAseq post-treatment on tumor samples (n=18). Not all pre-treatment samples are linked with pre-treatment samples * High coverage Whole exome DNAseq on pre-treatment tumor samples (n=3) matched with post-treatment metastasized lymph nodes isolated with laser microdissection (n=3) * All samples are ... (Show More)
Illumina HiSeq 2500 69

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