Surgical or radiotherapeutic intervention concerning large singular stable to progressive metastases in patients with BRAFV600-mutated melanoma receiving treatment with Encorafenib + Binimetinib

Conditions

Unresectable or metastatic melanoma with a BRAF V600 mutation (inoperable stage III or metastatic stage IV)

Brief summary

To determine progression free survival (PFS) after local treatment (radiotherapy / surgery / electrochemotherapy)

Detailed description

To evaluate response parameters: Overall Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Duration of Disease Control (DoDC), Duration of Stable Disease (DoSD), To determine progression-free survival rate (PFSR) at 1 year after local treatment (radiotherapy / surgery / electrochemotherapy), To determine time to treatment failure (TTF), To determine overall survival (OS), To evaluate Quality of Life (QoL) by means of questionnaires FACT-M, EQ-5D-5L, EORTC QLQ-C30, To evaluate safety / toxicity according to CTCAE Version 5.0 criteria: o Adverse events (overall and differentiated by patients undergoing surgery, radiotherapy or electrochemotherapy) o Adverse reactions concerning surgery, radiotherapy, electrochemotherapy, encorafenib and binimetinib, Exploratory study objectives: • To identify immune-related modes of treatment resistance, Exploratory study objectives: • To evaluate influence of the immune architecture of the metastases on the clinical outcome of patients

Related papers

No related papers found yet.

Interventions

DRUGENCORAFENIB

DRUGBINIMETINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To determine progression free survival (PFS) after local treatment (radiotherapy / surgery / electrochemotherapy)	—

Secondary

Measure	Time frame
To evaluate response parameters: Overall Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Duration of Disease Control (DoDC), Duration of Stable Disease (DoSD), To determine progression-free survival rate (PFSR) at 1 year after local treatment (radiotherapy / surgery / electrochemotherapy), To determine time to treatment failure (TTF), To determine overall survival (OS), To evaluate Quality of Life (QoL) by means of questionnaires FACT-M, EQ-5D-5L, EORTC QLQ-C30, To evaluate safety / toxicity according to CTCAE Version 5.0 criteria: o Adverse events (overall and differentiated by patients undergoing surgery, radiotherapy or electrochemotherapy) o Adverse reactions concerning surgery, radiotherapy, electrochemotherapy, encorafenib and binimetinib, Exploratory study objectives: • To identify immune-related modes of treatment resistance, Exploratory study objectives: • To evaluate influence of the immune architecture of the metastases on the clinical outcome of	—

Measure

Time frame

To evaluate response parameters: Overall Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Duration of Disease Control (DoDC), Duration of Stable Disease (DoSD), To determine progression-free survival rate (PFSR) at 1 year after local treatment (radiotherapy / surgery / electrochemotherapy), To determine time to treatment failure (TTF), To determine overall survival (OS), To evaluate Quality of Life (QoL) by means of questionnaires FACT-M, EQ-5D-5L, EORTC QLQ-C30, To evaluate safety / toxicity according to CTCAE Version 5.0 criteria: o Adverse events (overall and differentiated by patients undergoing surgery, radiotherapy or electrochemotherapy) o Adverse reactions concerning surgery, radiotherapy, electrochemotherapy, encorafenib and binimetinib, Exploratory study objectives: • To identify immune-related modes of treatment resistance, Exploratory study objectives: • To evaluate influence of the immune architecture of the metastases on the clinical outcome of

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Countries

Germany

Outcome results

None listed