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ClinicalTrial.gov identifier | Title | Conditions | Study type | Intervention/treatment | Estimated enrollment (patients) | Primary outcome | Secondary outcome |
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NCT03688347 | Microbiome in lung cancer and other malignancies | Lung cancer and other solid tumors | Observational | Nasal, skin, and oral swab, stool collection, and microbiota analysis | 40 | Identify and compare bacteria within given samples through a standard protocol and 16S rRNA amplicon; correlate data from samples with patient clinical information regarding overall response rates | Correlate data from samples with patient clinical information regarding overall response rates |
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NCT03934827 | MRx0518 in patients with solid tumours waiting surgical removal of the tumour | Lung cancer and other solid tumors | Phase 1 | MRx0518 vs. placebo capsules | 120 | Safety and tolerability of MRx0518 as determined through the collection of the number and severity of AEs, SAEs, changes in biochemistry, haematology, urinalysis laboratory results, and vital signs | Response of MRx0518 determined by the measurement of tumor markers; OS of patients who receive MRx0518 compared to placebo |
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NCT03168464 | Radiation and immune checkpoints blockade in metastatic NSCLC (BMS # CA209-632) | Metastatic NSCLC | Phase 1, 2 | Nivolumab, ipilimumab, and radiation therapy | 45 | Enhance ORR to the combination of nivolumab/ipilimumab in chemorefractory NSCLC and double the ORR of ipilimumab/RT, from 18% based on intent to treat to 36% | Changes in TCR repertoire in peripheral blood are associated with response to treatment; serum markers IFN-b, CXCL11, sMICA, sMICB levels/changes associated with patients’ response to the treatment; PFS; OS; associations of ORR with changes in the microbiome |
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