MRD trials

Urine and related bladder trials

Catalog items whose placement includes Trials. SunRISe-3 utDNA results are not published. TOMBOLA is plasma ctDNA, not utDNA.

1. Peer-reviewed

   clinical trial (not utDNA; context)

   Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer.

   Powles T, Catto JWF, Galsky MD, et al., including van der Heijden MS, NIAGARA Investigators.

   N Engl J Med 2024;391(19):1773-1786.

   n: 1063 (533 durvalumab, 530 comparison)

   Phase 3, cisplatin-eligible MIBC

   Assay: n/a (clinical end points)

   • 24-month EFS 67.8% vs 59.8%, HR 0.68 (0.56-0.82), P<0.001.
   • 24-month OS 82.2% vs 75.2%, HR 0.75 (0.59-0.93), P=0.01.

   co-author

2. Conference abstract

   plasma ctDNA (not utDNA)

   Circulating tumor DNA (ctDNA) in patients with MIBC who received perioperative durvalumab in NIAGARA.

   J Clin Oncol 2025;43(16_suppl):4503.

   n: BEP 462 of 1063 (237 D, 225 C)

   Exploratory plasma ctDNA in NIAGARA

   Assay: Signatera, tumor-informed (Natera)

   • Baseline ctDNA+ 57% (260/460), pre-RC 22% (94/422).
   • Clearance baseline to pre-RC: 41% durvalumab vs 31% comparator.
   • Non-pCR 97% (86/89) if pre-RC ctDNA+.
   • Post-RC ctDNA+ 9% (31/345).
   • EFS benefit of durvalumab reported in both baseline ctDNA+ and ctDNA- groups.

3. Conference abstract

   utDNA and plasma ctDNA

   Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients with MIBC who received perioperative durvalumab in NIAGARA.

   J Clin Oncol 2026;44(7_suppl):636. ASCO GU 2026. Conference abstract; not a full paper.

   n: BEP 265 of 1063 (25%; 134 D, 131 C); utDNA at BL n=205, pre-RC n=183

   Exploratory utDNA + ctDNA in NIAGARA, cisplatin-eligible MIBC, pre-cystectomy

   Assay: Personalized Signatera (Natera), same framework as the plasma test

   • Lower baseline utDNA associated with longer EFS (low vs high HR 0.65, 95% CI 0.40-1.04).
   • utDNA+ rate 85% at baseline, 55% pre-RC.
   • utDNA clearance associated with longer EFS (HR 0.24, 95% CI 0.09-0.62); clearance 39% vs 27% (12 points higher with durvalumab).
   • Pre-RC utDNA-: pCR 72% (55/76) vs 18% (17/96) if utDNA+.
   • utDNA+ correlated with noninvasive residual disease (<T2N0M0); ctDNA+ with invasive disease or N+/M+.
   • 24-month EFS: dual-negative 90% (83-97), utDNA+ only 75% (65-87), dual-positive 55% (41-75).

   Conference abstract, exploratory, 25% of ITT. Full paper not found in PubMed.

   UroToday interview, Michiel van der Heijden. Interview commentary (e.g. plasma thresholds used for urine) is not a paper result.

4. Peer-reviewed

   utDNA and plasma ctDNA MRD (exploratory) plus clinical end points

   Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results.

   Necchi A, Guerrero-Ramos F, Crispen PL, Herrera-Imbroda B, Garje R, Szabados B, Peyton CC, Pradere B, Ku JH, Shore N, Bogemann M, Preston MA, Xylinas E, Sanchez de Llano C, Gong C, Hasan M, Urtishak K, Battaglia S, Stitou H, Bhanvadia S, Sweiti H, Psutka SP (22 authors on PubMed; Galsky MD is not on this list).

   J Clin Oncol 2026;44(7):586-597. Published 3 December 2025.

   n: 159 treated; 88 cohort 1 and 46 cohort 2 underwent RC; utDNA available 67 at baseline, 65 at week 12

   Phase 2, cisplatin-ineligible or -refusing cT2-T4a N0M0 MIBC planned for RC; 5:3 randomization, cohort 1 TAR-200 + cetrelimab, cohort 2 cetrelimab alone. Data cutoff 9 May 2025.

   Assay: utDNA and ctDNA MRD; vendor and gene content not named in the abstract (vendor and gene content are not named in the abstract).

   • pCR, pOR (<=ypT1N0), 1-year RFS: 38%, 53%, 77% in cohort 1 vs 28%, 44%, 64% in cohort 2.
   • Baseline utDNA+ 55/67 (82.1%); week 12 utDNA+ 34/65 (52.3%).
   • Week-12 utDNA- and clearance correlated with pCR (P<10^-5 and P<10^-3 in abstract; Fisher P=5.4e-6 for week-12 status in results text).
   • 22/27 (81.5%) who achieved pCR were utDNA- at week 12 vs 7/33 (21.2%) who did not. ROC 0.80 (0.70-0.90); NPV 0.81.
   • Clearance in 14/30 (46.7%) with available data (7/18 C1, 7/12 C2). 12/15 (80.0%) baseline+ with pCR had clearance vs 2/15 (13.3%) without pCR.
   • ctDNA- at baseline and week 12 associated with longer RFS (P=0.04 and 0.01).
   • Authors: utDNA and ctDNA support further investigation as biomarkers for residual local and nonlocal disease, respectively.

   Not on the PubMed author list of this JCO paper. Galsky's own utDNA work is the HCRN GU16-257 PNAS 2026 paper.

5. Peer-reviewed

   clinical (utDNA not in main abstract)

   TAR-200 for BCG-Unresponsive High-Risk NMIBC: Results From the Phase IIb SunRISe-1 Study.

   Daneshmand S, Van der Heijden MS, Jacob JM, et al., including Necchi A.

   J Clin Oncol 2025;43(33):3578-3588.

   • The main paper’s abstract does not report utDNA. Complete numeric utDNA results from ESMO 2025 abstract 3088P were not extracted from the primary abstract, so those rates are not shown.

   ESMO 2025 abstract 3088P (Ann Oncol, S0923-7534(25)04622-8) and a J&J Medical Connect congress PDF address molecular markers including baseline urinary tumor DNA MRD. Complete numeric utDNA results were not independently extracted from the primary abstract. Rates from that abstract are not included.

6. Trial in progress

   utDNA results not published

   SunRISe-3: TAR-200 plus cetrelimab or TAR-200 versus BCG in BCG-naive high-risk NMIBC (trial in progress).

   e.g. ESMO 2023 2407TiP. No published utDNA results found.

   utDNA results: not published.

7. Peer-reviewed

   clinical outcomes in FGFR3/2-altered NMIBC; utDNA/urine FGFR monitoring not in final abstract

   Erdafitinib in Patients with High- and Intermediate-risk Non-muscle-invasive Bladder Cancer: Final Analysis of THOR-2 Study.

   Daneshmand S, Zaucha R, Catto JWF, Tran B, Master V, Lotan Y, et al., including Maranchie JK.

   Eur Urol 2026;89(2):165-173.

   • Cohort 1 (HR papillary, prior BCG), n=73, 2:1 erdafitinib vs intravesical chemo: median RFS NR (28.6 mo-NE) vs 11.6 mo, HR 0.28 (0.13-0.61), nominal P=0.0007.
   • Cohort 2 (CIS +/- papillary), n=16: CR 94% at 8 weeks, 81% at 32 weeks; mDoR 23.3 months.
   • Cohort 3 (IR), n=18: CR 89%.

   A urine FGFR or utDNA monitoring analysis is not described in the final-paper abstract. How FGFR3/2 alterations were ascertained (tissue vs urine) is not stated in that abstract.

8. Peer-reviewed

   plasma tumor-informed ctDNA (NOT utDNA)

   ctDNA-guided immunotherapy following radical cystectomy for muscle-invasive bladder cancer: results from the TOMBOLA trial.

   Dyrskjot L, Birkenkamp-Demtroder K, Nordentoft I, et al., including Jensen JB.

   Ann Oncol 2026;37(5):712-724.

   n: 192 enrolled, 178 assessable, median FU 34 months

   Danish multicenter, open-label, single-arm phase 2. MIBC after NAC and RC. ctDNA+ started atezolizumab up to 1 year; ctDNA- received IO only if imaging showed metastases.

   Assay: Serial tumor-informed plasma ctDNA (not utDNA)

   • 104 (58%) ctDNA+ within 2 years after RC, 63% of those within 4 months.
   • Median lead time ctDNA to imaging-confirmed recurrence: 90 days (range -61 to 961).
   • 60% (50/84) of ctDNA+ patients who completed atezo with scans/ctDNA for the primary end point achieved complete molecular and radiographic response.
   • 1-year RFS 97% if ctDNA- vs 76% if ctDNA+.

9. Peer-reviewed

   clinical bladder-sparing (context for utDNA follow-up)

   Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.

   Galsky MD, Daneshmand S, Izadmehr S, et al.

   Nat Med 2023;29(11):2825-2834.

   n: 76

   • cCR 43% (33/76, 95% CI 32-55%); 32 of 33 with cCR opted to forgo immediate cystectomy; PPV of cCR 0.97 (0.91-1).

10. Peer-reviewed

    plasma ctDNA and utDNA

    Monitoring of plasma and urine tumor-derived DNA to inform bladder-sparing approaches for patients with muscle-invasive bladder cancer.

    Galsky MD, Izadmehr S, Yu M, Curtis SD, Douville C, et al., including Bettegowda, Kinzler, Papadopoulos, Vogelstein, Wang Y.

    Proc Natl Acad Sci USA 2026;123(8):e2533449123.

    Exploratory liquid biopsy in the gem/cis/nivo bladder-sparing trial; tumor-informed academic assay; authors note relatively small sample.

    Assay: Tumor-informed academic ctDNA and utDNA assay

    • 3-year bladder-intact survival among cCR after four rounds of systemic therapy: 69%.
    • Metastatic risk if pretreatment ctDNA detectable vs undetectable: HR 4.68 (1.10-43.35), P=0.036.
    • Only 4.5% (1 of 22) with undetectable baseline ctDNA developed metastatic disease.
    • utDNA more sensitive than plasma ctDNA for residual disease in the bladder.
    • Detectable utDNA in patients with cCR associated with shorter bladder-intact survival, HR 6.47 (1.34-31.31), P=0.008.

    first author — this is the Galsky utDNA study

11. Peer-reviewed

    tissue/immune biomarkers; utDNA not in abstract

    Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial.

    Powles T, Kockx M, Rodriguez-Vida A, et al.

    Nat Med 2019.

    n: 95

    • pCR 31% (95% CI 21-41%). Biomarkers are tissue and immune contexture; utDNA is not reported in the abstract.

12. Peer-reviewed

    utDNA (UroAmp)

    Urine Tumor DNA to Stratify the Risk of Recurrence in Patients Treated with Atezolizumab for BCG-unresponsive NMIBC.

    St-Laurent MP, Singh P, McConkey DJ, et al., including Lerner SP, Black PC.

    Eur Urol 2025;88(5):430-434. SWOG S1605.

    n: UroAmp at baseline n=89 and 3 months n=77

    Assay: UroAmp

    • CR at 6 months: 13% of UroAmp+ vs 71% of UroAmp- at baseline (P<0.001).
    • 18-month EFS 23% vs 51% (HR 2.8, P<0.001).
    • Among 51 with no clinical evidence of disease at 3 months: 18-month EFS 38% if UroAmp+ vs 86% if negative (HR 3.5, P=0.01).