IO-based randomized trials using ctDNA MRD for patient selection, treatment decisions, or as an early endpoint
| Trial and disease | Study arms | Primary endpoint(s) | Use of ctDNA |
| c-TRAK TN NCT03145961 Moderate or high-risk early-stage TNBC | Adjuvant pembrolizumab versus observation | ctDNA by 12 months; ctDNA by 24 months; absence of ctDNA/ DFS at 6 months | Assign treatment: ctDNA-positive within 12 months randomized to pembrolizumab or observation; ctDNA-negative observed |
| MERMAID-1 NCT04385368 NSCLC stage II, III | Adjuvant durvalumab+SOC chemotherapy versus placebo+SOC chemotherapy | DFS | Inclusion criteria: ctDNA-positive after surgery |
| MERMAID-2 NCT04642469 NSCLC stage II, III | Adjuvant durvalumab versus placebo | DFS | Inclusion criteria: ctDNA-positive during 96-week surveillance period |
| IMvigor011 NCT04660344 Muscle-invasive bladder cancer | Adjuvant Atezolizumab versus chemotherapy | DFS | Inclusion criteria: ctDNA-positive within 20 weeks after cystectomy |
| DETECTION NCT04901988 Melanoma stage IIB/C | Adjuvant nivolumab versus observation | OS | Assign treatment: ctDNA-positive treated with nivolumab |
| SCION NCT04944173 NSCLC stage I | Durvalumab+SABR (ctDNA-negative) versus durvalumab+SABR (ctDNA-positive) versus Durvalumab+SABR followed by eight additional cycles of Durvalumab (ctDNA-positive) | DFS | Assign treatment: ctDNA-positive randomized to either no further therapy or eight additional cycles of durvalumab |
ctDNA, circulating tumor DNA; DFS, disease-free survival; IO, immuno-oncology; MRD, molecular residual disease; NSCLC, non-small cell lung cancer; SABR, stereotactic ablative radiotherapy; SOC, standard of care; TNBC, triple negative breast cancer.