Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNational Cancer Center, Japan
About this trial
Cutaneous angiosarcoma is a rare cancer for which effective treatment has not been developed sufficiently. Still, because it often occurs in elderly people, the number of patients is increasing due to the aging population. Cutaneous angiosarcoma is difficult to completely remove by surgery, and recurrence and metastasis after surgery are not uncommon. Therefore, chemotherapy, radiation therapy, and a combination of these are currently widely used as treatments. Traditionally, the anticancer drug used for cutaneous angiosarcoma was mainly doxorubicin. In recent years, it has been reported that cancer shrank in 18% of patients after two months of paclitaxel administration in a clinical trial. Therefore, paclitaxel has become more commonly used for cutaneous angiosarcoma. Other options include anthracycline anticancer drugs and gemcitabine. However, even with these anticancer drugs (and radiation therapy), cutaneous angiosarcoma progresses quickly, and some reports have said that the 5-year survival rate is 9%. This study is planned to develop a safer and more effective treatment for cutaneous angiosarcoma and will include 38 participants. In this study, eligible participants will receive combination chemotherapy with 200 mg of pembrolizumab (injection liquid, once every 3 weeks) and 20 mg of lenvatinib (capsule, once daily) for up to approximately two years as protocol treatment unless the criteria for termination meet. Before, during, and after the protocol treatment, participants will undergo many examinations and evaluations, including blood tests, urine tests, and imaging tests (e.g., x-ray, CT scan, or MRI) to assess the safety and efficacy of the protocol treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically diagnosed with cutaneous angiosarcoma.
Unresectable primary or metastatic disease.
No spinal metastases that require radiotherapy or surgical intervention.
No pericardial effusion, pleural effusion, or ascites that require treatment.
Disqualifiers
Persons previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
Individuals previously treated with lenvatinib or another angiogenesis inhibitor, including treatment for other cancer types.
Patients who are likely to be cured with chemoradiotherapy, at the discretion of the treating physician.
Patients who received radiation therapy within 14 days prior to enrollment or patients with radiation therapy-related toxicities at enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab plus Lenvatinib
DrugOne course is fixed at 21 days, and the length of course is not extended or shortened. Participants receive 200 mg of pembrolizumab injection intravenously over approximately 30 minutes on day 1 of each course, and take 20 mg of lenvatinib capsules orally once daily, preferably at the same time each day. Treatment with pembrolizumab and lenvatinib will be continued for up to 35 courses unless the criteria for termination of protocol treatment are met.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab plus lenvatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR) by central review
ORR by central review is the combined incidence of complete response (CR) and partial response (PR) of Best Overall Response in the full analysis set (FAS), and is assessed by the pre-appointed independent data monitoring committee. Best Overall Response is determined as the best overall response evaluated among CR, PR, SD (stable disease), PD (progressive disease), and NE (not evaluable).
Time frame
Overall Response is assessed every 6 weeks until 24 weeks after initiation of protocol treatment and every 12 weeks after 25 weeks until PD confirmation or post-study treatment initiation, an estimated average of 1 year.Secondary outcomes
1
Overall Response Rate (ORR) by institutional review
ORR by institutional review is the combined incidence of complete response (CR) and partial response (PR) of Best Overall Response in the full analysis set (FAS), and is assessed by the principal investigator of each study site. Best Overall Response is determined as the best overall response evaluated among CR, PR, SD (stable disease), PD (progressive disease), and NE (not evaluable).
Time frame
Overall Response is assessed every 6 weeks until 24 weeks after initiation of protocol treatment and every 12 weeks after 25 weeks until PD confirmation or post-study treatment initiation, an estimated average of 1 year.2
Progression-free survival (PFS)
PFS for each participant in FAS is defined as the period from the date of enrollment to the date on which PD is confirmed by institutional review or the date of death from any cause, which comes earlier.
Time frame
PFS is assessed every 6 weeks until 24 weeks after initiation of protocol treatment and every 12 weeks after 25 weeks until PD confirmation or post-study treatment initiation, an estimated average of 1 year.3
Overall Survival (OS)
OS for each participants in FAS is defined as the period from the date of enrollment to the date of death from any cause.
Time frame
OS is observed on days 1 and 8 on Course 1, days 1 on and after Course 2, at completion/termination, and every 6 months after completion/termination until the participant's death or loss to follow-up, an estimated average of 2 years.4
Disease Control Rate
Disease Control Rate is defined as the percentage of participants in FAS with Best Overall Response of CR, PR, and SD. Disease Control Rate is calculated based on both institutional review and central review.
Time frame
Disease Control Rate is assessed every 6 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks until PD confirmation or post-study treatment initiation, an estimated average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Japan
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov