Evaluation of Safety and Efficacy of Patients With Four and More Symptomatic Brain Metastases of Melanoma
|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: NCT03728465|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Brain Metastases||Biological: Nivolumab Biological: Ipilimumab||Phase 2|
Brain metastases are a frequent problem in patients with melanoma. Up to 50% of patients with unresectable metastatic melanoma will develop brain metastases during their lifetime with a median overall survival of 4 months. Surgical removal or stereotactic radiosurgery of brain metastases can improve overall survival in patients with a limited number of lesions, usually in the range of one to three brain metastases depending on neuroanatomical localization. This benefit is no longer present when considering patients with > 3 brain metastases. As cytotoxic chemotherapy and multiple chemotherapeutic agents show only limited activity in > 3 brain metastases patients, immune checkpoint inhibitors such as ipilimumab and nivolumab offer new opportunities to improve disease outcomes for these patients.
This open label phase II study evaluates safety and efficacy of combined treatment with ipilimumab and nivolumab in patients with stage IV melanoma with four or more symptomatic brain metastases, who are not eligible for surgery or radiosurgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Nivolumab in Patients With Four and More Symptomatic Brain Metastases of Melanoma|
|Actual Study Start Date :||April 10, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2024|
Experimental: Treatment Phase
Treatment phase is divided into the "Induction Phase" and "Maintenance Phase". During the induction phase patients are treated with 1 mg/kg nivolumab and 3 mg/kg ipilimumab, during the maintenance phase with nivolumab 3 mg/kg only .
In the induction phase of this study nivolumab is administered as a IV infusion in combination with ipilimumab at a dose of 1 mg/kg for 4 cycles at three weeks interval and in a maintenance phase alone at a dose of 3 mg/kg every two weeks.
Other Name: OPDIVO
In the induction phase of this study ipilimumab is administered as a IV infusion in combination with nivolumab at a dose of 3 mg/kg for 4 cycles at three weeks interval.
Other Name: YERVOY
- Intracranial Control Rate after 6 months of treatment [ Time Frame: 6 months ]Proportion of patients with complete intracranial responses (CR), partial intracranial responses (PR) or stable intracranial disease (SD) after 6 months of treatment.
- Overall survival [ Time Frame: 2 years ]Number of patients who stay alive after 2 years.
- Progression-free survival [ Time Frame: 2 years ]Number of patients without progression after 2 years.
- Stereotactic irradiation or surgery of brain metastases after partial tumor remission [ Time Frame: 2 years ]Percentage of patients in whom stereotactic irradiation or surgery of all metastases becomes applicable after partial tumor remission.
- Tolerability according to NCI-CTCAE-Criteria [ Time Frame: 2 years ]All adverse events of all grades.
- Best Overall Response Rate with Complete Respone (CR) [ Time Frame: 6 months ]Percentage of patients with CR at six months of treatment.
- Best Overall Response Rate with Partial Response (PR) [ Time Frame: 6 months ]Percentage of patients with PR at six months of treatment.
- Cognitive function evaluation by standardized diagnostic procedures [ Time Frame: 2 years ]Systemic longitudinal neuropsychological evaluation to investigate the influence of therapy on cognitive performance will be performed by standardized diagnostic procedures.
- Quality of life evaluation with RAND 36-Item Health Survey 1.0 [ Time Frame: 2 years ]Quality of life assessment is evaluated with the RAND 36-Item Health Survey questionnaires which include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Evaluation will be performed according to the manual.
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): NCT03728465
|Contact: Thomas Eigentler, Dr. med.||07071 29 firstname.lastname@example.org|
|Elbe Kliniken Stade - Buxtehude GmbH||Recruiting|
|Contact: Peter Mohr, Dr.med. Peter.Mohr@elbekliniken.de|
|Principal Investigator: Peter Mohr, Dr.med.|
|Universitätsklinik Carl Gustav Carus Dresden||Recruiting|
|Contact: Friedegund Meier, Prof.Dr.med. email@example.com|
|Principal Investigator: Friedegund Meier, Prof.Dr.med.|
|HELIOS Klinikum Erfurt||Recruiting|
|Contact: Rudolf Herbst, Prof.Dr.med. firstname.lastname@example.org|
|Principal Investigator: Rudolf Herbst, Prof.Dr.med.|
|Universitätsklinikum Essen||Not yet recruiting|
|Contact: Dirk Schadendorf, Prof.Dr.med. email@example.com|
|Principal Investigator: Dirk Schadendorf, Prof.Dr.med.|
|Contact: Jessica Hassel, Dr.med. firstname.lastname@example.org|
|Principal Investigator: Jessica Hassel, Dr.med.|
|Gesellschaft für Klinische Forschung Ludwigshafen mbH||Not yet recruiting|
|Contact: Edgar Dippel, Prof.Dr.med. email@example.com|
|Principal Investigator: Edgar Dippel, Prof.Dr.med|
|Contact: Jochen Utikal, Prof.Dr.med. Jochen.Utikal@umm.de|
|Principal Investigator: Jochen Utikal, Prof.Dr.med.|
|Klinikum rechts der Isar||Recruiting|
|Contact: Angela Krackhardt, Prof.Dr.med. firstname.lastname@example.org|
|Principal Investigator: Angela Krackhardt, Prof.Dr.med.|
|Harzklinikum Dorothea Christiane Erxleben GmbH||Recruiting|
|Contact: Jens Ulrich, Prof.Dr.med. email@example.com|
|Principal Investigator: Jens Ulrich, Prof.Dr.med.|
|Universitätsklinikum Regensburg||Not yet recruiting|
|Contact: Sebastian Haferkamp, Dr.med firstname.lastname@example.org|
|Principal Investigator: Sebastian Haferkamp, Dr.med|
|Contact: Thomas Eigentler, Dr.med. 07071 29 85748 email@example.com|
|Principal Investigator: Claus Garbe, Prof.Dr.med.|
|Principal Investigator:||Claus Garbe, Prof.Dr.med.||University Hospital Tuebingen|