NCT02410863: BOTTOM

Biopsy- and Biology-driven Optimization of Targeted Therapy of Metastatic Melanoma in BRAF Inhibitor Non-pretreated and Pretreated Subjects With Advanced, Non-resectable (STAGE IIIC) or Metastatic (StAGE IV) BRAF Mutation-positive Melanoma

Terminated Phase 2 Last updated 13 October 2020

What this trial tests

Phase 2 trial testing Dabrafenib in Malignant Melanoma in 10 participants. Terminated before completion.

Timeline

1 November 2015

Primary endpoint
1 August 2018

1 August 2018

Quick facts

Lead sponsor	Prof. Dr. med. Dirk Schadendorf
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 November 2015
Primary completion	1 August 2018
Estimated completion	1 August 2018
Sites	6 locations across Germany

Drugs / interventions tested

• Dabrafenib (dabrafenib) — full drug profile →
• Trametinib (trametinib) — full drug profile →

Conditions studied

• Malignant Melanoma — all drugs for Malignant Melanoma →

Sponsor

Prof. Dr. med. Dirk Schadendorf

Who can join

18 and older, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Correlation of clinical response at week 8 of targeted therapy with molecular results of the biopsies.
  Time frame: Week 8
  To broaden the understanding of molecular characterization of the melanoma in correlation to the clinical response (defined as partial or complete response according to RECIST) at week 8 of targeted therapy in different pre-treated patients with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.

Sponsor's own description

This is an open-label, multi-center, clinical phase II study to explore the correlation of the genetic make-up of the treated tumor before start of therapy and to correlate clinical response at 8 weeks as well as metabolic response at 2 and 8 weeks with genetic features of the tumor.

It will be conducted as a rationale optimization of targeted therapy in BRAF naïve and pretreated patients.

Prerequisite for all patients is the availability of tumor sample at start of treatment in order to determine the underlying driver mutation (BRAF mutational status) as well as molecular composition by next generation sequencing (NGS) and assessable lesions for biopsy at week 2. Melanoma patients in stage III (non-resectable) and stage IV are sorted into Cohort A or B according to their previous BRAF-treatment and treated with dabrafenib and trametinib (cohort A and B)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.