Biomarker-driven Therapy for Melanoma

Melanoma Clinical Trial

— TREAT20plus  

Official title:

Feasibility Study of Biomarker-driven Therapy Based on a Comprehensive Molecular Analysis of Tumor Tissue and Blood Collections in Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063058
• Other study ID #: TREAT20plus
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2021

Study information

• Verified date: September 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion.

The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of the patients treated according to recommendations or not. For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.

Description:

Eligible patients have to have a histologically proven metastatic melanoma failing standard treatments. Other inclusion criteria included age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; life expectancy ≥ 24weeks; adequate renal, liver, and bone marrow functions. Previous therapy with intravenous chemotherapy, immunotherapy or major surgery at least 4 weeks before inclusion was allowed. Patients were excluded if they had a history of cardiac disease or metastatic brain or meningeal tumors. The study is approved by the institutional research ethics board.

Molecular analysis is performed at the Max Planck Institute for Molecular Genetics Berlin and a comprehensive report is made available with 4-8 weeks. The molecular tumor board interprets the data and transforms them into treatment recommendations by identifying and prioritizing predictive biomarkers. The recommendations rely on the definition of evidence levels attributed to every single aberration and the interdisciplinary discussion of the aberrations with regard to patient situation, availability of drugs, and clinical trials. The recommendations are transmitted to the physician in charge of the patient for the final decision to treat or not the patient accordingly.

The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of patients treated according to recommendations or not.

For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically proven metastatic melanoma failing standard treatments

• age = 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

• life expectancy = 24 weeks

• adequate renal, liver, and bone marrow functions

Exclusion Criteria:

• history of cardiac disease or metastatic brain or meningeal tumors

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Molecular guided therapy
Biomarker-driven therapy according to recommandations of the precision oncology tumor board including MEK Inhibitors (Trametinib 2 mg/d, Selumetinib 75 mg 2/d), MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d), RAS Inhibitor (Sorafenib 400 mg 2/d), Cell cycle Inhibitor (Palbociclib 125 mg/d) and Checkpoint Inhibitor (Nivolumab 240 mg every 2 weeks).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Alacris, Max-Planck Institut

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (actionable molecular alterations)	number of patients with actionable molecular alterations	Through study completion over 5 years
Primary	Feasibility (number of patients with a treatment recommendation)	number of patients with a treatment recommendation	Through study completion over 5 years
Primary	Feasibility (number of patients receiving the recommended therapy)	number of patients receiving the recommended therapy	Through study completion over 5 years
Secondary	Overall survival	Overall survival	5 years
Secondary	Response rate	Response rate of the patients treated according to the recommendations	1 year
Secondary	Progression free survival at 6 months according to RECIST criteria	PFS according to RECIST criteria for the patients treated according to the recommendations	up to 6 months