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Correlative study in Protocol S1400I A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB IN STAGE IV SQUAMOUS CELL LUNG CANCER (CIMAC-CIDC)

ABSTRACT: Correlative study in Protocol S1400I A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB IN STAGE IV SQUAMOUS CELL LUNG CANCER (CIMAC-CIDC)

PROVIDER: PRJNA1014197 | ENA |

REPOSITORIES: ENA

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Correlative study in Protocol S1400I A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB IN STAGE IV SQUAMOUS CELL LUNG CANCER (CIMAC-CIDC)

Project description:Correlative study in Protocol S1400I A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB IN STAGE IV SQUAMOUS CELL LUNG CANCER (CIMAC-CIDC)

| PRJNA1014196 | ENA

Correlative studies in Protocol #9204, which studied ipilimumab or nivolumab in hematologic malignancies after transplantation, including studies in collaboration with CIMAC-CIDC

Project description:Correlative studies in Protocol #9204, which studied ipilimumab or nivolumab in hematologic malignancies after transplantation, including studies in collaboration with CIMAC-CIDC

| PRJNA970486 | ENA

Correlative studies in Protocol #9204, which studied ipilimumab or nivolumab in hematologic malignancies after transplantation, including studies in collaboration with CIMAC-CIDC

| PRJNA970487 | ENA

Correlative studies in NRG-GY021: Olaparib and tremelimumab in Ovarin cancer (CIMAC-CIDC)

Project description:Correlative studies in NRG-GY021: Olaparib and tremelimumab in Ovarin cancer (CIMAC-CIDC)

| PRJNA1085796 | ENA

Correlative studies in Protocol E4412, which studied Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma, in collaboration with CIMAC-CIDC

Project description:Correlative studies in Protocol E4412, which studied Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma, in collaboration with CIMAC-CIDC

| PRJNA1029315 | ENA

Correlative studies in Protocol NRG-LU004, which studied radiation and immunotherapy in lung cancer, in collaboration with CIMAC-CIDC

Project description:Correlative studies in Protocol NRG-LU004, which studied radiation and immunotherapy in lung cancer, in collaboration with CIMAC-CIDC

| PRJNA1066948 | ENA

Correlative studies for Protocol #14-C-0059, which studied anti-GD2-CAR T cells in GD2+ solid tumors, in collaboration with CIMAC-CIDC

Project description:Correlative studies for Protocol #14-C-0059, which studied anti-GD2-CAR T cells in GD2+ solid tumors, in collaboration with CIMAC-CIDC

| PRJNA1032220 | ENA

Correlative studies for Protocol #14-C-0059, which studied anti-GD2-CAR T cells in GD2+ solid tumors, in collaboration with CIMAC-CIDC

Project description:Correlative studies for Protocol #14-C-0059, which studied anti-GD2-CAR T cells in GD2+ solid tumors, in collaboration with CIMAC-CIDC

| PRJNA1032219 | ENA

Immune Profiling Mass Cytometry Assay Harmonization: Multicenter Experience from CIMAC-CIDC.

Project description:PurposeThe Cancer Immune Monitoring and Analysis Centers - Cancer Immunologic Data Commons (CIMAC-CIDC) Network is supported by the NCI to identify biomarkers of response to cancer immunotherapies across clinical trials using state-of-the-art assays. A primary platform for CIMAC-CIDC studies is cytometry by time of flight (CyTOF), performed at all CIMAC laboratories. To ensure the ability to generate comparable CyTOF data across labs, a multistep cross-site harmonization effort was undertaken.Experimental designWe first harmonized standard operating procedures (SOPs) across the CIMAC sites. Because of a new acquisition protocol comparing original narrow- or new wide-bore injector introduced by the vendor (Fluidigm), we also tested this protocol across sites before finalizing the harmonized SOP. We then performed cross-site assay harmonization experiments using five shared cryopreserved and one lyophilized internal control peripheral blood mononuclear cell (PBMC) with a shared lyophilized antibody cocktail consisting of 14 isotype-tagged antibodies previously validated, plus additional liquid antibodies. These reagents and samples were distributed to the CIMAC sites and the data were centrally analyzed by manual gating and automated methods (Astrolabe).ResultsAverage coefficients of variation (CV) across sites for each cell population were reported and compared with a previous multisite CyTOF study. We reached an intersite CV of under 20% for most cell subsets, very similar to a previously published study.ConclusionsThese results establish the ability to reproduce CyTOF data across sites in multicenter clinical trials, and also highlight the importance of quality control procedures, such as the use of spike-in control samples, for tracking variability in this assay.

| S-EPMC8448982 | biostudies-literature

Phase II Clinical and Immune Correlate Study of Adjuvant Nivolumab plus Ipilimumab for High-Risk Resected Melanoma

Project description:Background: Adjuvant therapy for high-risk resected melanoma with PD-1 blockade results in median relapse-free survival (RFS) of 5 years. The addition of low dose ipilimumab (IPI) to a regimen of nivolumab (NIVO) in Checkmate-915, did not result in increased RFS. A pilot phase II adjuvant study of either standard or low dose IPI with NIVO was conducted at two centers to evaluate RFS with correlative studies. Methods: Patients (pts) with resected stages IIIB/IIIC/IV melanoma received either IPI 3mg/kg and NIVO 1mg/kg (cohort 4) or IPI 1mg/kg and NIVO 3mg/kg (cohorts 5 and 6) induction therapy every three weeks for 12 weeks, followed by maintenance NIVO. Peripheral blood samples at baseline and on-treatment were assessed by flow cytometry for potential biomarkers. Peripheral CD8+ T-cells were assessed by RNA-Seq. Results: High rates of grade 3-4 adverse events precluded completion of induction therapy in 50%, 35% and 7% of patients in cohorts 4, 5 and 6 respectively. At a median of 63.9 months of follow up, 16/56 pts (29%) relapsed. For all patients, at five-years, RFS was 71% (95% CI: 60, 84), and overall survival was 94% (95% CI: 88, 100). Expansion of CD3+CD4+CD38+CD127-GARP- T-cells, an on-treatment increase in CD39 expression in CD8+ T-cells, and T-cell expression of phosphorylated STAT2 and STAT5 were associated with relapse. Conclusions: Adjuvant IPI/NIVO at the induction doses used resulted in excellent relapse-free survival, albeit with a high rate of grade 3-4 adverse events. Biomarker analyses highlight an association of ectoenzyme-expressing T-cells and STAT signaling pathways with relapse.

2022-12-02 | GSE219251 | GEO

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