Study

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 (ClinicalTrials.gov: 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 7 datasets.

Click on a Dataset ID in the table below to learn more, and to find out who to contact about access to these data

Dataset ID Description Technology Samples
EGAD00001006850
Data from NABUCCO cohort 1 (NCT03387761). This dataset includes Whole exome DNA sequencing on bladder tumor samples (n=24) matched with blood samples (n=24). The data is pre-treatment.
Illumina HiSeq 2500 48
EGAD00001006851
Data from NABUCCO cohort 1 (NCT03387761). This dataset includes Tumor mutational burden (TMB) calculated on bladder tumor pre-treatment DNA sequencing data (n=24). Details about the Tumor Mutational Burden calculation can be found on the Methods section from the Nature Medicine paper (https://doi.org/10.1038/s41591-020-1085-z)
24
EGAD00001006852
Data from NABUCCO cohort 1 (NCT03387761). This dataset includes High coverage Whole exome DNA sequencing on pre-treatment bladder tumor samples (n=3) matched with post-treatment metastasised adjacent lymph nodes isolated with laser microdissection (n=3) for 3 unique patients
Illumina HiSeq 2500 6
EGAD00001006853
Data from NABUCCO cohort 1 (NCT03387761). This dataset includes the Response labels used for the analysis of the data. Details about the clinical definitions of Response can be found on the paper (https://doi.org/10.1038/s41591-020-1085-z)
69
EGAD00001006854
Data from NABUCCO cohort 1 (NCT03387761). This dataset includes the Transcript read counts derived from the RNA sequencing data. The samples are pre-treatment (n=18) and post-treatment (n=18), and not all samples are paired. The data processing pipeline can be found on the Methods section from the Nature Medicine paper (https://doi.org/10.1038/s41591-020-1085-z)
42
EGAD00001006855
NABUCCO cohort 1 sequencing data. The dataset includes RNA sequencing pre-treatment on tumor samples (n=18) and RNA sequencing post-treatment on bladder tumor samples (n=18).
Illumina HiSeq 2500 36
EGAD00001006856
Data from NABUCCO cohort 1 (NCT03387761). This dataset includes the pre-treatment PD-L1 staining on tumor samples (n=24). Details about the PD-L1 staining can be found on the paper (https://doi.org/10.1038/s41591-020-1085-z)
24

Who archives the data?

There are no publications available