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New treatment option for Untreated Advanced or Recurrent Thymic Carcinomas
Official title First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)
ClinicalTrials.gov ID: NCT05832827
What this study is testing
What is MK-3475?
MK-3475 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for untreated advanced or recurrent thymic carcinomas.
Also referred to as Keytruda/MK-3475 (Pembrolizumab).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 years or older at the time of informed consent, who are pathologically (histologically or cytologically) diagnosed with thymic...
- Patients with unresectable advanced thymic carcinoma (equivalent to stage IVa or IVb of Masaoka-Koga classification), metastatic or recurrent, who...
- No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiotherapy or surgery
- No prior history of an antiangiogenetic agent targeting VEGFR for thymic carcinoma
- Not receiving radiotherapy within 14 days before registration Male participants
You likely can't join if
- Has diagnosed as thymomas
- Has related immune-related complications such as myasthenia gravis, pure red cell aplasia, or hypogammaglobulinemia
- Patients with ECG QT correction interval prolongation or history of such prolongation (patients with QTcF \> 480 ms)
- Has a LVEF below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to registration (see Appendix 3). If the urine test is positive or cannot be...
- Has urine protein ≥1 g/24 hours Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour...
See the full eligibility criteria
Who can join
- Patients aged 18 years or older at the time of informed consent, who are pathologically (histologically or cytologically) diagnosed with thymic carcinoma for primary or metastatic thymic lesions, are included. They are...
- Patients with unresectable advanced thymic carcinoma (equivalent to stage IVa or IVb of Masaoka-Koga classification), metastatic or recurrent, who have not been treated with systemic cancer chemotherapy. Or, in the case...
- No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiotherapy or surgery
- No prior history of an antiangiogenetic agent targeting VEGFR for thymic carcinoma
- Not receiving radiotherapy within 14 days before registration Male participants
- A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 135 days after the last dose of study treatment and refrain from donating sperm...
- A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.
- The participant provides written informed consent for the trial
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Meet the following criteria for Hepatitis B and C Patients with no history of HBV or HCV infection or who meet the following criteria 10.1 Hepatitis B positive people Participants who are HBsAg positive are eligible if...
- Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days before registration.
- Have adequate organ function as defined in the following table (Table 8). Specimens must be collected within 14 days prior to registration.
- Have a predicted life expectancy of \>12 weeks
What rules you out
- Has diagnosed as thymomas
- Has related immune-related complications such as myasthenia gravis, pure red cell aplasia, or hypogammaglobulinemia
- Patients with ECG QT correction interval prolongation or history of such prolongation (patients with QTcF \> 480 ms)
- Has a LVEF below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to registration (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Has urine protein ≥1 g/24 hours Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria
- Has had major surgery within 3 weeks prior to the first dose of study interventions
- Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial...
- Has any of the following a) to i):
- History of interstitial pneumonia or evidence of interstitial lung disease
- Uncontrollable autoimmune disease receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy
- History or complications of hypertensive crisis or hypertensive encephalopathy
- Surgery under general anesthesia within 28 days before registration
- History of total gastrectomy
- Complication of congenital bleeding predisposition or abnormal coagulation
- Complication of Grade 3 or higher gastrointestinal or non-gastrointestinal fistula with CTCAE v5.0
- History of Grade 3 or higher bleeding (site not specified) with CTCAE v5.0 within 28 days prior to registration
- Blood pressure is not well controlled (with 2 or fewer antihypertensive drugs\ 2, systolic blood pressure is 150 mmHg or less and diastolic blood pressure is 90 mmHg or less) \ Antihypertensive drugs are counted by the...
- Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
- Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
- Active hemoptysis (bright red blood of at least 0.5 teaspoons) within 3 weeks prior to the first dose of the study drug
- Has received prior radiotherapy within 14 days before registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed. Approved COVID-19 vaccines (excluding live vaccines and/or...
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention Note: Participants who have...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in...
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at...
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of Human Immunodeficiency Virus (HIV) infection
- Concurrent active Hepatitis B ( defined as HBsAg positive and detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Is expecting to father...
- Has had an allogeneic tissue/solid organ transplant
The study team makes the final eligibility decision.
Where it's taking place
- Chūō, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chūō, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.