A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
← catalyst calendarNCT07689812 · readout ≤ 2,691 d
Sponsored by Natera, Inc. (industry) · NTRA — their whole pipeline →.
Phase
Not applicable
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
920estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Dec 2026 | estimated | When the study began enrolling |
| Primary completion | Dec 2033 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2034 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer)
- NSCLC (Non-small Cell Lung Cancer)
- NSCLC (Non-small Cell Lung Carcinoma)
- NSCLC
- Melanoma (Skin Cancer)
- Melanoma (Skin) Stage IV
- CRC
- MSI High Colorectal Cancer
- DMMR Colorectal Cancer
- RCC, Renal Cell Cancer
- RCC
- Solid Tumors
- Metastatic Solid Tumors
- Advanced Solid Tumors
- Advanced Solid Tumors Cancer
Intervention
- Device: Signatera Genome ultra-sensitive ctDNA blood test
Primary outcomes
what the primary-completion date above is the date OFTo demonstrate that ctDNA-guided intermittent ICI therapy results in at least 50% of patients who do not reinitiate systemic therapy prior to 6 months from randomization.
measured 6 months from randomization
To demonstrate that ctDNA-guided intermittent ICI therapy is non-inferior to SoC continuous ICI therapy as measured by 36 month OS in advanced/metastatic solid tumor patients.
measured 3 years from randomization to death from any cause
Publications
- PMID 41690366 — cited as background
- PMID 36950275 — cited as background
- PMID 37270700 — cited as background
- PMID 39284954 — cited as background
- PMID 41375005 — cited as background
- PMID 36869646 — cited as background
- PMID 39022993 — cited as background
- PMID 37156405 — cited as background
- PMID 39414578 — cited as background
- PMID 39693589 — cited as background
- PMID 33264544 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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