NCT04760080 (CHLORO-DATRAM) is a clinical trial of pre-treatment data in Dermatology and Oncology, sponsored by Hospices Civils de Lyon.

Who is sponsoring NCT04760080?

NCT04760080 is sponsored by Hospices Civils de Lyon.

What drugs are being tested in NCT04760080?

Interventions in NCT04760080: pre-treatment data, during study treatment.

What condition does NCT04760080 study?

NCT04760080 studies Dermatology and Oncology.

Is NCT04760080 still recruiting?

NCT04760080 is currently completed. Last updated 18 February 2021.

Last reviewed 2021-02-18 · How we verify

NCT04760080: CHLORO-DATRAM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Association of Hydroxychloroquine, BRAF and MEK Inhibitors in Metastatic Melanoma : a Retrospective Case-control Study.

Completed Last updated 18 February 2021

What this trial tests

trial testing pre-treatment data in Dermatology and Oncology in 31 participants. Completed in 1 October 2020.

Timeline

1 January 2019

Primary endpoint
1 October 2020

1 October 2020

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	31
Start date	1 January 2019
Primary completion	1 October 2020
Estimated completion	1 October 2020
Sites	1 location across France

Drugs / interventions tested

pre-treatment data
during study treatment

Conditions studied

Dermatology and Oncology — all drugs for Dermatology and Oncology →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Dermatology and Oncology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with a BRAF mutated melanoma are usually treated in France by a first line of immunotherapy followed by a second line that combines a BRAF inhibitor (dabrafenib, vemurafenib, encorafenib) and a MEK inhibitor (trametinib, cobimetinib, binimetinib). The combination dabrafenib/trametinib is initially very efficient but it is unfortunately limited because acquired resistances usually occur after a year of treatment. Patients who become resistant to dabrafenib/trametinib and immunotherapy, unfortunately do not have an approved effective treatment at their disposal. They usually receive a palliative chemotherapy by dacarbazine or fotemustine, and they have a mean overall survival that is less than three months. Activation of autophagy in presence of BRAF and MEK inhibitors is a known mechanism of resistance to BRAF/MEK inhibitors. Hydroxychloroquine is an autophagy inhibitor and it has been suggested in vitro that it could decrease resistance to BRAF/MEK inhibitors. Following the positive results in 2018 of a phase I/II study in the USA that showed the efficacy and the absence of toxicity of the association of Dabrafenib, Trametinib and hydroxychloroquine when used as a first line treatement, we proposed to our patients who had become resistant to the dabrafenib/trametinib combination, to pursue their treatment beyond progression and to receive in addition hydroxychloroquine. This prescription was initiated in patients for whom no further therapeutic options were available, after validation by a multidisciplinary tumor board. All patients were informed that the combination dabrafenib/trametinib/hydroxychloroquine was not approved by a regulatory agency.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Programmed cell death: molecular mechanisms, biological functions, diseases, and therapeutic targets.
Qian S, Long Y, Tan G, Li X, et al · · 2024 · cited 24× · PMID 39619229 · DOI 10.1002/mco2.70024

Verify or expand the search:

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04760080 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Hospices Civils de Lyon
Last refreshed: 18 February 2021

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/NCT04760080.

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