Cemiplimab for Secondary Angiosarcomas

NCT04873375 | Completed Phase 2

• 1 other identifier: 2020-005465-13
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Angiosarcoma; Locally Advanced Sarcoma; Metastasis

Keywords

Secondary Angiosarcoma; Cemiplimab; immunotherapy; Angiosarcoma; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) after 24 weeks of cemiplimab

  To evaluate the overall response rate (ORR) after 24 weeks of cemiplimab in secondary angiosarcomas, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 or daylight photography as per WHO Offset Publication No. 48.

  From the date of study inclusion until 24 weeks after inclusion. Interim analysis after 13 patients

Secondary Outcomes (8)

• Best Overall Response Rate

  From the date of study inclusion to the end of the treatment period. Assessed up to 2 years after inclusion

• Time to response and duration of response

  From the date of study inclusion to the date of response or progression. Assessed up to 2 years after inclusion

• Progression free survival (PFS)

  Counting from the date of study inclusion to the date of progressive disease or death. Assessed up to 2 years after inclusion.

• Overall survival (OS)

  From the date of study inclusion to the date of death. If study medication is discontinued for any reason, survival follow-up takes place every 12 weeks, also assessed up to 2 years

• Relation between tumor characteristics and response to treatment

  2-3 years

Study Arms (1)

Cemiplimab

EXPERIMENTAL

After inclusion, all patients will be treated with Cemiplimab 350mg intravenously every three weeks

Drug: Cemiplimab

Interventions

Cemiplimab DRUG

After inclusion patients will be treated with Cemiplimab 350mg intravenously every three weeks

Also known as: LIBTAYO

Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient aged ≥ 18 years.
• Signed written informed consent.
• Histologically confirmed diagnosis of progressive unresectable locally advanced or metastatic secondary angiosarcoma.
• Patients in the first line of systemic treatment unfit for chemotherapy and patients in advanced lines of systemic treatment.
• Measurable disease per RECIST 1.1 or per physical examination / daylight photography (WHO Offset Publication No. 48) as determined by the investigator.
• Tumour tissue material available (archival or recent tumour biopsy).
• WHO ECOG 0-2.
• Hepatic function:
• Total bilirubin ≤ 1.5 x ULN (if liver metastases: ≤ 3 x ULN).
• Transaminases ≤ 3 x ULN (if liver metastases: ≤ 5 x ULN).
• Patients with Gilbert's Disease and total bilirubin up to 3x ULN may be eligible after communication with and approval from the medical monitor
• Alkaline phosphatase ≤ 2.5 x ULN (if liver OR bone metastases ≤5 x ULN).
• Renal function: serum creatinine ≤ 2 x ULN or estimated CrCl \> 30 mL/min.
• Creatine phosphokinase (CPK) (also known as CK \[creatine kinase\]) elevation ≤ grade 2
• Bone marrow function:

You may not qualify if:

• Prior treatment with immune checkpoint inhibitors.
• Continuous immunosuppressive corticosteroid treatment (doses \> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab. Note: patients who require a brief course of steroids (e.g. as prophylaxis for imaging studies) are not excluded.
• Active uncontrolled infection requiring therapy, including infection with HIV, active infection with HBV or HCV.
• History of pneumonitis within the last 5 years.
• Untreated brain metastasis(es) that may be considered active.
• a. Note in clarification: Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period), and there is no evidence of new or enlarging brain metastases, and the patients do not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 28 days of the first dose of cemiplimab.
• Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients must be excluded. Specifically, because of the presence of trace components in cemiplimab, patients with allergy or hypersensitivity to doxycycline or tetracycline are excluded.
• History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
• Patients with a history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the medical monitor).
• Any anticancer treatment other than radiation therapy (chemotherapy, targeted systemic therapy, imiquimod, photodynamic therapy), investigational or standard of care, within 30 days of the initial administration of cemiplimab or planned to occur during the study period
• Receipt of live vaccines (including attenuated) within 30 days of first study treatment
• Prior use of PI3K-D inhibitors
• Women of childbearing potential (WOCBP)\*, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 6 months after the last dose.
• Breastfeeding
• Any other condition that might interfere with experimental treatment and the study procedures as judged by the investigator.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Genzyme Europe B.V.: collaborator

Study Sites (1)

RadboudUMC

Nijmegen, 6525AG, Netherlands

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Hemangiosarcoma; Sarcoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients included in this interventional single arm study will be treated with cemiplimab

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: January 1, 2022
• Primary Completion: October 9, 2024
• Study Completion: October 18, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)