Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873375
Status:
RECRUITING
Last Update Posted:
2022-02-03
First Post:
2021-04-26
Brief Title:
Cemiplimab for Secondary Angiosarcomas
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Cemiplimab Treatment in Patients With Locally Advanced and Metastatic Secondary Angiosarcomas
Status:
RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Secondary angiosarcomas are aggressive mesenchymal tumors with a poor prognosis and limited therapeutic options Recent studies conducted in patients with cutaneous squamous-cell carcinoma provide evidence that cemiplimab has the potential to be an effective treatment also for patients with secondary angiosarcomas
The purpose of this study is to evaluate the overall response rate after 24 weeks of cemiplimab treatment in patients with locally advanced or metastatic secondary angiosarcomas
The investigators hypothesis is that cemiplimab could be an effective treatment for patients diagnosed with locally advanced and metastatic secondary angiosarcomas
The purpose of this study is to evaluate the overall response rate after 24 weeks of cemiplimab treatment in patients with locally advanced or metastatic secondary angiosarcomas
The investigators hypothesis is that cemiplimab could be an effective treatment for patients diagnosed with locally advanced and metastatic secondary angiosarcomas
Detailed Description:
Study design A prospective interventional non-randomized multicenter phase II clinical trial
Hypothesis
Cemiplimab is registered for the use in patients with cutaneous squamous-cell carcinoma In these patient groups cemiplimab showed impressive results There are numerous similarities between cutaneous squamous-cell carcinoma and secondary angiosarcomas Based on these similarities including a complex genetic background PD-L1 expression and MYC expression the investigators hypothesize that cemiplimab might be an effective treatment for locally advanced and metastatic secondary angiosarcomas
Primary Objective
To evaluate the overall response rate ORR after 24 weeks of cemiplimab in secondary angiosarcomas according to Response Evaluation Criteria in Solid Tumours RECIST 11 or daylight photography as per WHO Offset Publication No 48
Secondary Objectives
Secondary objectives include the establishment of the best ORR median time to response duration of response and progression free survival The secondary objectives also comprise safety and toxicity quantification and to investigate the relation between response to cemiplimab and various tumor characteristics
Study Population
Patients eligible for inclusion are at least 18 years of age with adequate organ function who have a histologically confirmed diagnosis of progressive unresectable locally advanced or metastatic secondary angiosarcoma Patients eligible are patients in the first line of treatment if they are unfit for chemotherapy and patients in advanced lines of systemic treatment Major exclusion criteria include significant ongoing autoimmune disease that requires immunosuppressive treatment prior treatment with immune checkpoint inhibitors active uncontrolled infections or recent pneumonitis All patients will provide Informed Consent prior to inclusion in the study and during the course of the trial al relevant data will be stored in electronic Case Report Forms eCRF
Treatment Schedule
After study inclusion patients will be treated with Cemiplimab 350mg intravenously every three weeks Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects withdrawal of consent or other reasons The maximum treatment period will be two years as is standard of care for patients treated with immunotherapy
Hypothesis
Cemiplimab is registered for the use in patients with cutaneous squamous-cell carcinoma In these patient groups cemiplimab showed impressive results There are numerous similarities between cutaneous squamous-cell carcinoma and secondary angiosarcomas Based on these similarities including a complex genetic background PD-L1 expression and MYC expression the investigators hypothesize that cemiplimab might be an effective treatment for locally advanced and metastatic secondary angiosarcomas
Primary Objective
To evaluate the overall response rate ORR after 24 weeks of cemiplimab in secondary angiosarcomas according to Response Evaluation Criteria in Solid Tumours RECIST 11 or daylight photography as per WHO Offset Publication No 48
Secondary Objectives
Secondary objectives include the establishment of the best ORR median time to response duration of response and progression free survival The secondary objectives also comprise safety and toxicity quantification and to investigate the relation between response to cemiplimab and various tumor characteristics
Study Population
Patients eligible for inclusion are at least 18 years of age with adequate organ function who have a histologically confirmed diagnosis of progressive unresectable locally advanced or metastatic secondary angiosarcoma Patients eligible are patients in the first line of treatment if they are unfit for chemotherapy and patients in advanced lines of systemic treatment Major exclusion criteria include significant ongoing autoimmune disease that requires immunosuppressive treatment prior treatment with immune checkpoint inhibitors active uncontrolled infections or recent pneumonitis All patients will provide Informed Consent prior to inclusion in the study and during the course of the trial al relevant data will be stored in electronic Case Report Forms eCRF
Treatment Schedule
After study inclusion patients will be treated with Cemiplimab 350mg intravenously every three weeks Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects withdrawal of consent or other reasons The maximum treatment period will be two years as is standard of care for patients treated with immunotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None