MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

October 15, 2019

Primary Completion Date

January 3, 2023

Study Completion Date

January 3, 2023

Conditions
Metastatic NRAS Melanoma
Interventions
DRUG

Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 1)

"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.~• Level -1 = Hydroxychloroquine 400 mg by mouth once a day"

DRUG

Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 2)

"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.~• Level 1 (starting dose) = Hydroxychloroquine 800 mg by mouth once a day"

DRUG

Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 3)

"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.~• Level 2 = Hydroxychloroquine 600 mg by mouth two times a day"

Trial Locations (5)

31000

INSTITUT Claudius Rigaud, Toulouse

38700

CHU Grenoble Alpes, La Tronche

63003

CHU Estaing, Clermont-Ferrand

69310

Centre Hospitalier Lyon Sud, Lyon

75010

AP-HP_HOPITAL Saint Louis, Paris

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03979651 - MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma | Biotech Hunter | Biotech Hunter