Study on the Safety and Effectiveness of CJRB-101 with Pembrolizumab for Advanced or Metastatic Cancer

Inclusion Criteria

• Must be willing and able to provide informed consent.
• Must be 18 years or older.
• Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), or melanoma.
• Must have at least one measurable tumor that has not been removed or treated before joining the study.
• Must have advanced cancer that cannot be removed by surgery or has spread, and either have not been treated with immune checkpoint inhibitors (ICI) or have not responded to them.
• For those not previously treated with ICI:
  • NSCLC: Must not have certain genetic changes and must have a specific protein level (PD-L1).
  • HNSCC: Must have a specific protein level (PD-L1).
  • Melanoma: No specific protein or genetic requirements.
  • Must not have received prior treatment for metastatic cancer, except if previous treatment was completed at least 6 months before cancer spread.
• For those who did not respond to ICI:
  • Must have received at least 2 cycles of ICI treatment.
  • Must have shown disease progression after ICI treatment.
  • Must have received less than three lines of treatment for metastatic cancer.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must be willing to provide a tumor sample.
• Must have adequate organ function.
• Any severe side effects from previous treatments must have improved to a mild level.

Exclusion Criteria

• Have certain genetic changes in NSCLC or specific types of HNSCC.
• Have had severe immune-related side effects from previous treatments.
• Have untreated or uncontrolled brain cancer spread.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have had a fecal transplant.
• Are participating in another clinical trial or using another investigational drug within 30 days.
• Cannot have IV contrast due to allergies that cannot be managed.
• Are pregnant or breastfeeding.
• Are unable or unwilling to use birth control.
• Cannot swallow capsules.
• Have received a live vaccine within 4 weeks of starting the study.
• Have a history of immune deficiency or organ transplant requiring immune suppression.
• Have had a blood transfusion or growth factors within 1 week before starting the study.
• Are unlikely to follow study procedures.
• Have active or a history of lung disease requiring steroids.
• Are allergic to certain antibiotics.
• Have symptoms of colitis.
• Have an infection requiring treatment within 14 days before the study.
• Have untreated or active hepatitis B or C.
• Have a history of HIV.
• Have active inflammatory bowel disease with recent symptoms.
• Have had major surgery within 4 weeks before the study.
• Have a history of major gastrointestinal surgery.
• Have any condition that might affect the study results.
• Have significant heart disease.
• Have a history of drug or alcohol abuse.
• Have any contraindications as mentioned in the pembrolizumab prescribing information.