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NCT04761783
BESPOKE Study of ctDNA Guided Immunotherapy
trial in Colorectal Cancer in 290 participants. Completed in 30 March 2024.
31 December 2023
Quick facts
| Lead sponsor | Natera, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 290 |
| Start date | 28 May 2021 |
| Primary completion | 31 December 2023 |
| Estimated completion | 30 March 2024 |
| Sites | 1 location across United States |
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Melanoma — all drugs for Melanoma →
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Sponsor
Natera, Inc.
Who can join
18 and older, any sex, with Colorectal Cancer or Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective data collection study of patients with advanced solid tumors who will receive standard of care immunotherapy (IO) and will be monitored with SIGNATERA™ testing. SIGNATERA™ test will be performed at baseline and during routine care. The test results will be part of assessing tumor response. The correlation between SIGNATERA™ test results and subsequent treatment decisions will be examined to compare actual treatment delivered against treatment decisions potentially impacted by SIGNATERA™ results. Treatment administered, tumor assessment results, time to progression, overall survival, physician questionnaires, and patient-reported outcomes will be collected/recorded.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mutated circulating tumor DNA as a liquid biopsy in lung cancer detection and treatment.
Filipska M, Rosell R. · · 2021 · cited 24× · PMID 33969622 · DOI 10.1002/1878-0261.12983 -
The Use of Gene Expression Profiling and Biomarkers in Melanoma Diagnosis and Predicting Recurrence: Implications for Surveillance and Treatment.
Sun J, Karasaki KM, Farma JM. · · 2024 · cited 19× · PMID 38339333 · DOI 10.3390/cancers16030583 -
Locally advanced rectal cancer with dMMR/MSI-H may be excused from surgery after neoadjuvant anti-PD-1 monotherapy: a multiple-center, cohort study.
Yang R, Wu T, Yu J, Cai X, et al · · 2023 · cited 16× · PMID 37441082 · DOI 10.3389/fimmu.2023.1182299 -
Decoding the Dynamics of Circulating Tumor DNA in Liquid Biopsies.
Turabi K, Klute K, Radhakrishnan P. · · 2024 · cited 14× · PMID 39001494 · DOI 10.3390/cancers16132432 -
Personalized, tumor-informed, circulating tumor DNA assay for detecting minimal residual disease in non-small cell lung cancer patients receiving curative treatments.
Oh Y, Yoon SM, Lee J, Park JH, et al · · 2024 · cited 13× · PMID 38558374 · DOI 10.1111/1759-7714.15281 -
Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
David P, Mittelstädt A, Kouhestani D, Anthuber A, et al · · 2023 · cited 10× · PMID 37046585 · DOI 10.3390/cancers15071924 -
BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours.
Kasi PM, Chakrabarti S, Sawyer S, Krainock M, et al · · 2022 · cited 9× · PMID 35636789 · DOI 10.1136/bmjopen-2021-060342 -
Liquid biopsy for diagnostic and prognostic evaluation of melanoma.
Slusher N, Jones N, Nonaka T. · · 2024 · cited 7× · PMID 39156972 · DOI 10.3389/fcell.2024.1420360
Verify or expand the search:
- PubMed search for NCT04761783
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Natera, Inc. trials
Trials by the same sponsor.
- NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
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- NCT06620627 — Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection · recruiting
- NCT05309382 — Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04761783 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Natera, Inc.
- Last refreshed: 15 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04761783.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing