Biomarker-driven Therapy for Melanoma

NCT05063058 | Completed

• 1 other identifier: TREAT20plus
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (3)

• Feasibility (actionable molecular alterations)

  number of patients with actionable molecular alterations

  Through study completion over 5 years

• Feasibility (number of patients with a treatment recommendation)

  number of patients with a treatment recommendation

  Through study completion over 5 years

• Feasibility (number of patients receiving the recommended therapy)

  number of patients receiving the recommended therapy

  Through study completion over 5 years

Secondary Outcomes (3)

• Overall survival

  5 years

• Response rate

  1 year

• Progression free survival at 6 months according to RECIST criteria

  up to 6 months

Study Arms (1)

Molecular guided therapy

EXPERIMENTAL

Drug: Molecular guided therapy

Interventions

Molecular guided therapy DRUG

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).

Molecular guided therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- history of cardiac disease or metastatic brain or meningeal tumors

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Max-Planck Institut: collaborator
• Alacris: collaborator

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Charité Comprehensive Cancer Center

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 30, 2021
• Study Start: January 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: August 1, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09