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"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)" | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

NCT05299580•Fondazione Melanoma Onlus

View on ClinicalTrials.gov

Summary

There is evidence from cohort studies and metanalysis that a shift from BRAFWT to BRAF mutated melanomas can occur (Colombino JCO 2012, Valchis EJC 2017). Based on previous studies we expect that 15% of tissue BRAF WT patients treated with anti PD-1 will become circulating free DNA BRAF (CfDNA BRAF) mutation-positive and, at progression, they will be elegible to be treated with dabrafenib/trametinib. We aimed to design a clinical phase II trial in order to evaluate the activity of Dabrafenib and Trametinib in patients with Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients of either sex aged ≥ 18 years;
•2. Histologically confirmed stage III (unresectable) or stage IV melanoma;
•3. Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy;
•4. Tumor biopsy, if feasible, to confirm the BRAFV600 mutation at progression;
•5. Previous adjuvant treatment, including checkpoint inhibitors anti CTLA-4, anti PD- 1/PDL-1 is allowed, except for stage IV (if completed at least 6 months prior to enrollment, and all related adverse events have either returned to baseline or stabilized). BRAF inhibitor treatment in adjuvant setting is not permitted;
•6. Last previous treatment for metastatic disease MUST BE Anti-PD1 as single agent;
•7. Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels;
•8. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
•9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 (see Appendix II);
•10. Female subjects of childbearing potential must have a negative pregnancy test result at baseline and must practice two highly effective methods of contraception for the duration of the study, EOT, at 30-day and 150-day safety follow up;
+4 more criteria

Exclusion Criteria

•1. Symptomatic brain metastases;
•2. History of another malignancy, exception: subjects who have been disease-free for 3 years, (i.e. subjects with second malignancies that are indolent or definitively treated at least 3 years ago) or subjects with a history of completely resected nonmelanoma skin cancer;
•3. A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy including:
•* Presence of predisposing factors to RVO or central serous retinopathy (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes); or
•* Visible retinal pathology as assessed by ophthalmic examination that is considered a risk factor for RVO or central serous retinopathy such as: i. Evidence of new optic disc cupping; ii. Evidence of new visual field defects on automated perimetry; iii. Intraocular pressure \>21 mmHg as measured by tonometry.
•4. A history of clinically significant or active interstitial lung disease or pneumonitis;
•5. Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures;
•6. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and HCV infection will be permitted);
•7. A history or evidence of cardiovascular risk including any of the following:
•* Current LVEF \< LLN;
+13 more criteria

Locations (16)

IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori (I.R.S.T) S.r.l.

Meldola, Forlì-Cesena, Italy

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

Alessandria, Italy

National Institute of Cancer

Bari, Italy

Università degli Studi di Bari Aldo Moro

Bari, Italy

AOU Sant'Orsola-Malpighi

Bologna, Italy

ASST Spedali Civili Brescia

Brescia, Italy

Azienda Sanitaria Ospedaliera S. Croce e Carle

Cuneo, Italy

IRCCS San Martino - IST

Genova, Italy

Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria di Modena

Modena, Italy

Key Dates

Start Date

February 18, 2021

Primary Completion Date

March 30, 2023

Completion Date

March 30, 2023

Last Updated

September 14, 2023

Conditions

Melanoma

Interventions

dabrafenib

DRUG

Trametinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

Inclusion Criteria

Exclusion Criteria

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