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Report for Clinical Trial NCT03898908

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II, Multicentre Clinical Trial to Evaluate the Activity of Encorafenib and Binimetinib Administered Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain

Phase II clinical trial, with two cohorts of patients included in parallel, all with melanoma BRAF mutated and brain metastases without previous local treatment in the brain. Cohort 1 will include patients with asymptomatic brain metastases and cohort 2 will include patients with symptomatic brain metastasis.

NCT03898908 Metastatic Melanoma Brain Metastases
MeSH:Melanoma Neoplasm Metastasis
HPO:Cutaneous melanoma Melanoma

4 Interventions

Name: encorafenib

Description: Encorafenib 75mg and 50mg (capsules) for a 450mg daily for oral administration during 56 days and after local radiation treatment. If no progression of disease progression (PD) is reported, treatment will continue until PD, unacceptable toxicity or death.
Type: Drug
Group Labels: 1

COMBO450

Name: binimetinib

Description: Binimetinib 15mg (tablets) for a 45mg/12 hours for oral administration during 56 days and after local radiation treatment.
Type: Drug
Group Labels: 1

COMBO450

Name: Whole brain radiation therapy

Description: The whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks.
Type: Radiation
Group Labels: 1

COMBO450

Name: Radiosurgery/stereotactic radiosurgery

Description: Dose selection must be based on previously published Radiation Therapy Oncology Group (RTOG) data, with dose modification left up to the treating physician. The total dose will depend on the size of the metastatic lesion(s) and proximity to critical structures. Suggested doses are as follow: 1 fraction x 15-25 Gy; 3 fractions x 9-11 Gy; 5 fractions x 6-7 Gy; or 6 fractions x 5-6 Gy. For GTV > 20 mm hypofractionated stereotactic radiotherapy could be preferred. Treatment will be delivered once daily, alternate-day, 3 fractions per week.
Type: Radiation
Group Labels: 1

COMBO450


Primary Outcomes

Description: iORR calculated as the proportion of patient with a best overall intracranial response of complete response (CR) or partial response (PR) before local treatment in cohort 1. The final statistical analysis of this endpoint is expected to be performed within 3 months after the local treatment of the last patient in cohort 1. This outcome will be assessed on day 56, and every 8 weeks up to 24 months after start of treatment

Measure: Intracranial objective response by RECIST 1.1 before local radiotherapy treatment in cohort 1

Time: 24 months after start of treatment

Secondary Outcomes

Description: ORR calculated as the proportion of patient with a best overall intracranial response of complete response (CR) or partial response (PR) before local treatment in cohort 1. The final statistical analysis of this endpoint is expected to be performed within 3 months after the local treatment of the last patient in cohort 2. This outcome will be assessed on day 56, and every 8 weeks up to 24 months after start of treatment

Measure: Intracranial objective response by RECIST 1.1 before local radiotherapy treatment in cohort 2

Time: 24 months after start of treatment

Measure: Global intracranial response in both cohorts

Time: 24 months

Measure: Duration of intracranial response in both cohorts

Time: 24 months

Measure: Duration of global response in both cohorts

Time: 24 months

Measure: Intracranial progression-free survival (PFS) by RECIST 1.1 in both cohorts

Time: 24 months

Measure: Global (intracranial and extracranial) progression-free survival in both cohorts

Time: 24 months

Measure: Percentage of patients free of progression (intracraneal and extracraneal)

Time: 24 months

Measure: Overall survival in both cohorts

Time: 24 months

Measure: Percentage of patients alive in both cohorts

Time: 24 months

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 until local treatment in both cohorts

Time: 24 months

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after local treatment in both cohorts

Time: 24 months

Description: Compared to baseline evaluation evaluated after 8 weeks since the start of treatment

Measure: Change on Quality of life at week 8 in both cohorts based on the EORTC QLQ 30 scale

Time: 8 weeks

Description: Compared to baseline evaluation evaluated after 24 weeks since the start of treatment

Measure: Change on Quality of life at week 24 in both cohorts based on the EORTC QLQ 30 scale

Time: 24 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

- Histologically confirmed diagnosis of unresectable metastatic cutaneous melanoma, or unknown primary melanoma with one or more brain metastasis with a diameter of 10 to 50 mm, measured by contrast enhanced MRI. - Presence of a BRAF V600E or V600K mutation, or both, in their tumour tissue. --- V600E ---


2 V600K

- Histologically confirmed diagnosis of unresectable metastatic cutaneous melanoma, or unknown primary melanoma with one or more brain metastasis with a diameter of 10 to 50 mm, measured by contrast enhanced MRI. - Presence of a BRAF V600E or V600K mutation, or both, in their tumour tissue. --- V600E --- --- V600K ---



HPO Nodes


HPO: