Table 2. Selected clinical trials that incorporate ICI biomarkers in the trial eligibility criteria or in the trial intervention.
This table summarizes tissue and blood biomarker–based immuno-oncology clinical trials. TMB, tumor mutation burden; MSI, microsatellite instability; dMMR, mismatch repair deficient; HRD, homologous recombination deficiency; NSCLC, non–small cell lung cancer.
| NCT | Phase | Biomarker | Intervention | Condition | Status |
|---|---|---|---|---|---|
| NCT05197322 | II | TMB, MSI | Pembrolizumab | Colorectal cancer | Not yet recruiting |
| NCT03638297 | II | MSI-H/dMMR | BAT 1306, pembrolizumab | Colorectal cancer | Recruiting |
| NCT04940637 | II | PD-L1, HRD | Dostarlimab | NSCLC | Recruiting |
| NCT03911557 | II | TMB | Durvalumab, tremelimumab | Somatically hypermutated tumors | Recruiting |
| NCT04589845 | II | TMB | Atezolizumab | Solid tumors | Recruiting |
| NCT02693535 | II | TMB | Pembrolizumab | Solid tumors | Recruiting |
| NCT04006262 | II | MSI | Nivolumab, ipilimumab | Localized esophagogastric adenocarcinoma | Recruiting |
| NCT04730544 | II | MSI | Nivolumab, ipilimumab | Colorectal cancer | Recruiting |
| NCT05468138 | II | MSI | Anti–PD-1 | Operable gastric cancer | Recruiting |
| NCT04008030 | III | MSI | Nivolumab, ipilimumab | Colorectal cancer | Recruiting |
| NCT05118724 | II | MSI | Atezolizumab | Colorectal cancer | Recruiting |
| NCT02912572 | II | MSI, POLE mutation | Avelumab | Endometrial cancer | Recruiting |
| NCT02997228 | III | dMMR | Atezolizumab | Colorectal cancer | Recruiting |
| NCT05201612 | II | HRD | Pembrolizumab | Solid tumors | Not yet recruiting |
| NCT04317105 | I/II | PTEN, PIK3CA mutations | Copanlisib, nivolumab, ipilimumab | Solid tumors | Recruiting |
| NCT05472623 | II | KRAS mutation | Adagrasib, nivolumab | NSCLC | Not yet recruiting |
| NCT04059887 | IV | blood TMB | Atezolizumab | Lung cancer | Recruiting |
| NCT04940286 | II | ctDNA | Durvalumab | Pancreatic adenocarcinoma | Recruiting |
| NCT04638582 | II | ctDNA | Pembrolizumab | NSCLC | Not yet recruiting |
| NCT04644289 | II | ctDNA | Durvalumab | Epithelial ovarian cancer | Recruiting |
| NCT04849364 | II | ctDNA | Atezolizumab | Triple-negative breast cancer | Recruiting |
| NCT04434040 | II | ctDNA | Atezolizumab | Triple-negative breast cancer | Recruiting |
| NCT04660344 | III | ctDNA | Atezolizumab | High-risk muscle-invasive bladder cancer | Recruiting |
| NCT04585477 | II | ctDNA | Durvalumab | Early-stage NSCLC | Recruiting |
| NCT04966663 | II | ctDNA | Nivolumab | Early-stage NSCLC | Recruiting |
| NCT03832569 | I | ctDNA | Pembrolizumab | Solid tumors | Recruiting |
| NCT04625699 | II | ctDNA | Durvalumab, tremelimumab | NSCLC | Not yet recruiting |
| NCT04966676 | II | ctDNA | Nivolumab and ipilimumab | NSCLC | Not yet recruiting |
| NCT04166487 | II | ctDNA | Pembrolizumab | NSCLC | Recruiting |
| NCT03808441 | II | ctDNA | Nivolumab and ipilimumab | Melanoma | Recruiting |