SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02631447

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Three Arms Prospective, Randomized Phase II Study to Evaluate the Best Sequential Approach With Combo Immunotherapy (Ipilimumab/Nivolumab) and Combo Target Therapy (LGX818/MEK162) in Patients With Metastatic Melanoma and BRAF Mutation

To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation.

NCT02631447 Metastatic Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

4 Interventions

Name: LGX818

Description: LGX818 450 mg p.o. od
Type: Drug
Group Labels: 3

Arm A: Combo Target/Combo Immuno Arm B: Como immuno/Combo Target Arm C: Sandwich

Name: MEK162

Description: MEK162 45 mg p.o. bid
Type: Drug
Group Labels: 3

Arm A: Combo Target/Combo Immuno Arm B: Como immuno/Combo Target Arm C: Sandwich

Name: Nivolumab

Description: Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks
Type: Drug
Group Labels: 3

Arm A: Combo Target/Combo Immuno Arm B: Como immuno/Combo Target Arm C: Sandwich

Name: Ipilimumab

Description: Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks
Type: Drug
Group Labels: 3

Arm A: Combo Target/Combo Immuno Arm B: Como immuno/Combo Target Arm C: Sandwich


Primary Outcomes

Description: OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication

Measure: Overall Survival

Time: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 24 month

Secondary Outcomes

Description: PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Tumor responses will be assessed by the Investigator according to RECIST Criteria (version 1.1)

Measure: Total Progression free survival

Time: Baseline (Day 1), every 6 weeks until second disease progression is documented (Approximately around 2 years)

Description: Percentage of patients alive at 2 and 3 years will be reported using Wilson score intervals.

Measure: Percentage of patients alive at 2 and 3 years;

Time: Time Frame: at 24^ and 36^ month

Description: It will be calculated as the percentage of ITT population patients who have a CR o o PR before any evidence of progression (as defined by RECIST).

Measure: Best overall response rate (BORR);

Time: Time Frame: up to 24 months

Description: It will be calculated as the percentage of ITT population patients who have a CR o o PR before any evidence of progression (as defined by RECIST).

Measure: Duration of response (DoR);

Time: Time Frame: up to 24 months

Description: Safety and tolerability will be assessed in terms od AEs, laboratory data, ECG data, vitals signs and weight, which will be collected for all patients. AEs (both in terms od MedDRA preferred terms and CTCAE grade), laboratory data, ECG data, vital signs and weight will be listes individually by patient and summarized by treatment received. ECG changes will be summarized for each treatment group.

Measure: Toxicity of the investigational medicinal products (IMPs).

Time: Time Frame: up to 24 months

Description: Changes from baseline in EQ-5D and QLQ-C30 total score will be summarized by means of descriptive statistical methods.

Measure: Quality of life and general health

Time: Time Frame: up to 24 months

Description: 3 years PFS rate; calculated from the date of randomization;

Measure: 3 years PFS rate

Time: Time Frame: up to 36 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 V600E

4. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria; 5. Presence of BRAF V600E or V600K mutation in tumor tissue prior to enrollment; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 7. Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. --- V600E ---


2 V600K

4. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria; 5. Presence of BRAF V600E or V600K mutation in tumor tissue prior to enrollment; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 7. Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. --- V600E --- --- V600K ---



HPO Nodes


HPO: