TY - JOUR
T1 - Dataset of phase I and II immunotherapy clinical trials used for a meta-analysis to assess the role of biomarkers in treatment outcomes in diverse cancers
AU - Fountzilas, Elena
AU - Hiep Vo, Henry
AU - Mueller, Peter
AU - Kurzrock, Razelle
AU - Tsimberidou, Apostolia Maria
N1 - Publisher Copyright:
© 2023
PY - 2023/12
Y1 - 2023/12
N2 - We performed a literature search in PubMed to identify phase I/II clinical trials with immunotherapy drugs approved by the Food and Drug Administration (labeled, off-label, and/or combined with investigational immune checkpoint inhibitors or other treatment modalities) from 2018 to 2020. We used the following key words: clinical trials, phase 1, Phase 2; and the following filters: cancer, humans; and selected the checkpoint inhibitors that had been approved by the FDA by March 2021, i.e., “pembrolizumab”, “nivolumab”, “atezolizumab”, “durvalumab”, “cemiplimab”, “avelumab”, and “ipilimumab. Clinical trials with their checkpoint inhibitors as in their labeled indications, off-label use or their combinations with investigational immune checkpoint inhibitors or other treatment modalities were included. Studies describing supportive care or locoregional treatments; cellular, viral, or vaccine therapy; studies in the adjuvant or neoadjuvant setting; and pediatric studies were excluded. Overall, 173 articles reporting on relevant studies were identified. Using these articles, we compiled a data file of study-specific covariates for each study. We recorded the immunotherapeutic agent, tumor type and biomarker, and clinical outcomes (objective response rate and median values [point estimate] and confidence intervals for progression-free survival and overall survival. Using these data, we carried out meta-analyses for the three outcomes and meta-regression on study-specific covariates. The same data could be used for any alternative implementation of meta-analysis and meta-regression, using more structured inference models reflecting different levels of dependence based on the available study-specific covariates.
AB - We performed a literature search in PubMed to identify phase I/II clinical trials with immunotherapy drugs approved by the Food and Drug Administration (labeled, off-label, and/or combined with investigational immune checkpoint inhibitors or other treatment modalities) from 2018 to 2020. We used the following key words: clinical trials, phase 1, Phase 2; and the following filters: cancer, humans; and selected the checkpoint inhibitors that had been approved by the FDA by March 2021, i.e., “pembrolizumab”, “nivolumab”, “atezolizumab”, “durvalumab”, “cemiplimab”, “avelumab”, and “ipilimumab. Clinical trials with their checkpoint inhibitors as in their labeled indications, off-label use or their combinations with investigational immune checkpoint inhibitors or other treatment modalities were included. Studies describing supportive care or locoregional treatments; cellular, viral, or vaccine therapy; studies in the adjuvant or neoadjuvant setting; and pediatric studies were excluded. Overall, 173 articles reporting on relevant studies were identified. Using these articles, we compiled a data file of study-specific covariates for each study. We recorded the immunotherapeutic agent, tumor type and biomarker, and clinical outcomes (objective response rate and median values [point estimate] and confidence intervals for progression-free survival and overall survival. Using these data, we carried out meta-analyses for the three outcomes and meta-regression on study-specific covariates. The same data could be used for any alternative implementation of meta-analysis and meta-regression, using more structured inference models reflecting different levels of dependence based on the available study-specific covariates.
KW - Biomarker
KW - Clinical trial
KW - Immunotherapy
KW - MSI
KW - Meta-analysis
KW - Multivariate analysis
KW - PD-L1
UR - http://www.scopus.com/inward/record.url?scp=85174962392&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85174962392&partnerID=8YFLogxK
U2 - 10.1016/j.dib.2023.109698
DO - 10.1016/j.dib.2023.109698
M3 - Article
C2 - 38020439
AN - SCOPUS:85174962392
SN - 2352-3409
VL - 51
JO - Data in Brief
JF - Data in Brief
M1 - 109698
ER -