Actively Recruiting
First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)
Led by National Cancer Center, Japan · Updated on 2023-10-23
35
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Japan
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase II, investigator-initiated, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab combination for previously untreated advanced or recurrent thymic carcinomas
CONDITIONS
Official Title
First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at informed consent
- Pathologically diagnosed thymic carcinoma, preferably positive for CD5 or c-KIT
- Unresectable advanced, metastatic, or recurrent thymic carcinoma not previously treated with systemic chemotherapy
- Stage III patients deemed unable to have radical resection or curative chemoradiotherapy
- No symptomatic brain or spinal metastases requiring radiotherapy or surgery
- No prior antiangiogenetic agent targeting VEGFR treatment for thymic carcinoma
- No radiotherapy within 14 days before registration
- Male participants agree to use contraception during treatment and for 135 days after last dose
- Female participants not pregnant, not breastfeeding, and either not of childbearing potential or agree to contraception during treatment and for 120 days after last dose
- Written informed consent provided
- Measurable disease based on RECIST 1.1
- Hepatitis B or C patients meeting specific viral load and treatment criteria
- Archival or newly obtained tumor tissue sample provided
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Adequate organ function within 14 days prior to registration
- Predicted life expectancy greater than 12 weeks
You will not qualify if you...
- Diagnosis of thymoma
- Immune-related complications such as myasthenia gravis, pure red cell aplasia, or hypogammaglobulinemia
- QT interval prolongation (QTcF > 480 ms) or history of such
- Left ventricular ejection fraction below institutional normal range
- Positive pregnancy test within 72 hours prior to registration for women of childbearing potential
- Urine protein ≥1 g/24 hours
- Major surgery within 3 weeks before first dose
- Clinically significant cardiovascular disease within 12 months prior
- History of interstitial pneumonia or lung disease
- Uncontrollable autoimmune disease requiring high-dose steroids or immunosuppressants
- History or complications of hypertensive crisis or encephalopathy
- Surgery under general anesthesia within 28 days before registration
- History of total gastrectomy
- Bleeding disorders or severe gastrointestinal fistulas
- Poorly controlled blood pressure
- Radiographic evidence of major blood vessel invasion or tumor cavitation
- Conditions affecting absorption of lenvatinib
- Active hemoptysis within 3 weeks before first dose
- Radiotherapy within 14 days before registration without full recovery
- Live vaccine within 30 days before first dose
- Participation in other investigational studies within 4 weeks before first dose
- Immunodeficiency or recent immunosuppressive therapy
- Active malignancy requiring treatment in past 3 years except certain skin or in situ cancers
- Active brain metastases or meningitis
- Severe hypersensitivity to pembrolizumab
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Concurrent active Hepatitis B and C infections
- Psychiatric or substance abuse disorders interfering with trial
- Pregnant, breastfeeding, or expecting to conceive during study period
- History of allogeneic tissue or organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital
Chūō, Tokyo, Japan, 104-0045
Actively Recruiting
Research Team
Y
Yusuke Okuma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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