Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases (RadioCoBRIM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03430947|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : April 29, 2020
This is a phase II, open label, non-randomised study of vemurafenib and cobimetinib after radiosurgery in adult patients with BRAFV600-mutant melanoma brain metastases. All patients will receive vemurafenib 960 mg twice a day on days 1 - 28 combined with cobimetinib 60 mg once a day on days 1 - 21 of each 28-day treatment cycle until disease progression, drug toxicity or death.
The primary objective of this study is to determine the best overall response rate (BORR) in the brain. The extracranial BORR, intra- and extracranial duration of response, progression-free survival and overall survival, adverse events, quality of life and radiomics features predicting long-term local control of brain metastases and treatment-related toxicity will also be examined.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma Stage IV BRAF V600 Mutation Brain Metastases||Drug: Vemurafenib Drug: Cobimetinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase II Multicenter Study of Vemurafenib (Zelboraf®) Plus Cobimetinib (Cotellic®) After Radiosurgery in Patients With Active BRAF-V600-mutant Melanoma Brain Metastases|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
all patients will be treated with Vemurafenib + Cobimetinib
Vemurafenib (960 mg twice a day) will be taken on days 1 - 28 of each 28-day treatment cycle.
Cobimetinib (60 mg once a day) will be taken on days 1 - 21 of each 28-day treatment cycle.
- Best overall response rate in the brain [ Time Frame: 2 years ]rate of patients with complete response or partial response (intracranial)
- Extracranial best overall response rate [ Time Frame: 2 years ]rate of patients with complete response or partial response (extracranial)
- Best overall response rate calculated for the whole body tumor sites [ Time Frame: 2 years ]rate of patients with complete response or partial response
- Intracranial duration of response [ Time Frame: 2 years ]time from best overall response in the brain to first documentation of intracranial progression
- Extracranial duration of response [ Time Frame: 2 years ]time from best extracranial overall response to first documentation of extracranial progression
- Progression-free survival [ Time Frame: 2 years ]time from first dose of study treatment until progression
- Overall survival [ Time Frame: 2 years ]time from first dose of study treatment until death due to any cause
- Incidence of adverse events [ Time Frame: 2 years ]Adverse events by type, frequency and severity using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; number of patients who withdraw from the study due to intolerable adverse events.
- Radiomics for long-term control of brain metastases [ Time Frame: every 6 weeks up to 2 years ]Radiomics features predictive of long-term local control of brain metastases using Magnetic Resonance Imaging
- Radiomics for intracranial Treatment-related toxicity [ Time Frame: every 6 weeks up to 2 years ]Radiomics features predicting treatment-related toxicity (e.g. radionecrosis, hemorrhage, edema) using Magnetic Resonance Imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430947
|Contact: Friedegund Meier, MD||+49 351 458 ext firstname.lastname@example.org|
|Contact: Esther Troost, MD||+49 351 458 ext email@example.com|
|Technische Universität Dresden||Recruiting|
|Dresden, Germany, 01307|
|Contact: Friedegund Meier, MD +49 351 458 ext 2497 firstname.lastname@example.org|
|Contact: Esther Troost, MD +49 351 458 ext 2394 email@example.com|
|Principal Investigator: Friedegund Meier, MD|
|Principal Investigator: Esther Troost, MD, PhD|
|Ruprecht-Karls-University of Heidelberg, Faculty of Medicine||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Jessica Hassel, MD|
|Eberhard Karls University of Tübingen, University Medical Center||Recruiting|
|Tuebingen, Germany, 72076|
|Contact: Thomas Eigentler, MD|
|Principal Investigator:||Friedegund Meier, MD||Technische Universität Dresden|