Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are:
- What medical problems to participants have when taking OT101 together with Pembrolizumab?
- What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy?
- Does the combination therapy delay progression or relapse of the participant's Non-Small Cell Lung Cancer?
Participants will:
- Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion.
- Receive intravenous Pembrolizumab once every 6 weeks.
Full description
The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are:
- What medical problems to participants have when taking OT101 together with Pembrolizumab?
- What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy?
- Does the combination therapy delay progression or relapse of the participants Non-Small Cell Lung Cancer?
Participants will:
- Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion.
- Receive intravenous Pembrolizumab once every 6 weeks.
In Phase I, dose escalation/de-escalation of OT101/Trabedersen is performed using a BOIN design to determine dose limiting toxicity (DLT) and the recommended phase 2 dose (RP2D) when combined with Pembrolizumab.
In Phase II, subjects receive the RP2D of OT101/Trabedersen together with Pembrolizumab until disease relapse, progression [as determined by immune Response Evaluation Criteria in Solid Tumours (iRECIST) criteria], or death.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Age ≥ 19 years
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A histologically/cytologically proven diagnosis of non-small cell lung cancer (NSCLC) with a PD-L1 of at least 1%
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Metastatic disease or disease not amenable for curative intent therapy
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Have not received any prior treatment for metastatic NSCLC. Early-stage disease therapy acceptable if completed at least six months prior and did not include immunotherapy.
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Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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Must have measurable disease by RECIST criteria
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Adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mm3
- Platelets ≥100,000/mm3
- Hemoglobin >9.0 mg/dL
- Creatinine clearance > 60 ml/min/1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Total serum bilirubin <1.5 X upper limit of normal (ULN) except if known to have Gilbert's syndrome, then excluded if total bilirubin >2.5 X ULN
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 x ULN; if participant has liver metastases, ≤5x ULN
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For females of childbearing potential, negative serum or urine pregnancy test ≤7 days of treatment, & agree to use effective contraceptive during the treatment & 90 days after end of treatment
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Male participants must agree to use effective contraception during the trial & for 90 days after end of treatment
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Able to give informed consent
Exclusion criteria
- Has received any systemic treatments including investigational agents within the last 28 days
- Known hypersensitivity to any of the excipients of OT101 or pembrolizumab
- Has received radiotherapy within 14 days of the study intervention. Palliative radiation is allowed during the study with a 1-week washout
- Pregnant or breast-feeding women
- History of autoimmune diseases that has required systemic treatment in the past 2 years with agents such as but not limited to corticosteroids or immunosuppressive drugs. Thyroid replacement for hypothyroidism, insulin treatment for type I diabetes or corticosteroids adrenal/pituitary insufficiency are allowed.
- Uncontrolled systemic diseases that in the opinion of the investigator may interfere with the protocol activities
- Known active second malignancy that needs treatment. Exceptions include basal cell or squamous cancers of the skin, bladder or cervical carcinoma in situ, prostate cancer on hormone therapy alone.
- Immunodeficiency diagnosis or receiving chronic steroids that exceed a dose equivalent to prednisone 10 mg daily
- Has symptomatic brain metastases. Asymptomatic metastases or having received treatment for brain metastases and are off steroid therapy is acceptable.
- Known psychiatric or substance use that would interfere with the study requirements
- Inability to co-operate with the requirements of the protocol
Trial design
Primary purpose
Allocation
Interventional model
Masking
45 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Taylor A Johnson, MA; Samuel P Anderson, BS
Data sourced from clinicaltrials.gov
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