Clinical trial readouts and studies that assign or monitor treatment with an MRD assay.
In the phase 2/3 DYNAMIC-III trial published in Nature Medicine on October 20, 2025, 702 of 968 evaluable patients with stage III colon cancer were ctDNA-negative 5 to 6 weeks after surgery; 3-year recurrence-free survival was 87% if ctDNA-negative and 49% if ctDNA-positive, de-escalation in the ctDNA-negative group did not meet non-inferiority (85.3% versus 88.1%), and escalation in the ctDNA-positive group did not improve 2-year recurrence-free survival (51% versus 61%).
Nature Medicine
In the phase 3 IMvigor011 trial published in NEJM, 250 of 761 monitored patients with muscle-invasive bladder cancer tested ctDNA-positive after cystectomy and were randomized to atezolizumab or placebo, with median disease-free survival of 9.9 versus 4.8 months (HR 0.64) and median overall survival of 32.8 versus 21.1 months (HR 0.59); persistently ctDNA-negative patients were not treated on study and had a 95% disease-free survival at 1 year.
New England Journal of Medicine
ClinicalTrials.gov lists the observational TiMBER study (NCT07726602), led by OHSU, as recruiting from a June 29, 2026 start date to test whether Labcorp Plasma Detect ctDNA corresponds with recurrence after curative-intent treatment for muscle-invasive urothelial carcinoma.
ClinicalTrials.gov
In a biomarker analysis of the phase 2 COMRADE trial presented at ASCO GU 2026, undetectable ctDNA at cycle 2 day 1 was associated with longer radiographic progression-free survival than detectable ctDNA (median 9.9 versus 2.7 months; HR 0.47) among 94 analyzed patients with bone-dominant metastatic castration-resistant prostate cancer.
UroToday
In the phase 3 ALTAIR trial published in Nature Medicine on June 8, 2026, 243 patients with resected colorectal cancer who became tumor-informed ctDNA-positive without radiographic disease were randomized to trifluridine/tipiracil or placebo; median disease-free survival was 9.30 versus 5.55 months (HR 0.79; P = 0.107), so the primary endpoint was not met.
Nature Medicine
ClinicalTrials.gov lists NCT07401316, a diagnostic study led by Indiana University with Natera, as recruiting from a June 3, 2026 start date to measure the positive predictive value of ctDNA in high-risk stage I, stage II, and stage III germ cell tumors.
ClinicalTrials.gov
On July 10, 2026, the FDA extended perioperative pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin to adults with muscle-invasive bladder cancer who are candidates for cystectomy, including those eligible for cisplatin; in KEYNOTE-B15/EV-304 (808 patients) event-free survival HR was 0.53 and overall survival HR was 0.65 versus neoadjuvant gemcitabine and cisplatin.
U.S. FDA
In the same DYNAMIC-III analysis published in Nature Medicine on October 20, 2025, patients with stage III colon cancer whose ctDNA stayed positive after treatment had a 3-year recurrence-free survival of 14%, compared with 79% among patients who cleared ctDNA.
Nature Medicine
ClinicalTrials.gov lists ADAPT-MRD (NCT06966440) as a recruiting randomized trial that started June 1, 2025, assigning patients after resection of pancreatic cancer to ctDNA-guided adjuvant therapy or standard adjuvant therapy.
ClinicalTrials.gov
In the phase 3 ZEST trial, reported at SABCS 2024, enrollment stopped early after 1,901 patients had a tumor-informed ctDNA result and only 40 were randomized; of 147 patients with ctDNA detected, 72 (49%) already had radiographic recurrence on staging before randomization.
Clinical Cancer Research
A 2025 methods report describes DETECTION-2 (ISRCTN13695430), a feasibility randomization of patients with resected stage IIB, IIC, or IIIA melanoma to standard adjuvant therapy or to ctDNA monitoring with treatment if ctDNA is detected, and states that eight UK sites opened between November 27 and December 23, 2024.
EJC Skin Cancer
At ESMO 2024, an updated IMpower010 analysis of resected stage II to IIIA non-small cell lung cancer reported that postoperative ctDNA positivity was a negative prognostic factor for disease-free survival after at least 5 years of follow-up, and that disease-free survival was longer with atezolizumab than with best supportive care in both ctDNA-positive and ctDNA-negative groups.
Annals of Oncology
On June 12, 2026, the FDA approved belzutifan with pembrolizumab, or with pembrolizumab and berahyaluronidase alfa-pmph, as adjuvant treatment for adults with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastases; in LITESPARK-022 (1,841 patients) disease-free survival HR was 0.72 and median disease-free survival was not reached in either arm.
U.S. FDA
On May 28, 2026, the FDA approved durvalumab with BCG for adults with BCG-naive high-risk non-muscle-invasive bladder cancer, based on POTOMAC (1,018 patients), where durvalumab plus BCG induction and maintenance improved investigator-assessed disease-free survival versus BCG alone (HR 0.68; median not reached in either arm).
U.S. FDA
On November 21, 2025, the FDA approved pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin as neoadjuvant treatment and adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer who are ineligible for cisplatin; in KEYNOTE-905/EV-303 (344 patients) event-free survival HR was 0.40 and overall survival HR was 0.50 versus surgery alone.
U.S. FDA