Camu-Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Non-small Cell Lung Cancer and Melanoma

Exclusion Criteria

• •1. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment;
• •2. Has a diagnosis of severe immunodeficiency (e.g. transplantation) or receiving systemic steroid therapy (\>10mg prednisone daily or equivalent) or any other form of active immunosuppressive therapy at the discretion of the sponsor;
• •a. Patients with well-controlled HIV who are on HAART and have undetectable viral load are permitted to enroll;
• •3. Use of probiotics. Probiotics must be discontinued a minimum of 2 weeks before CC administration and patients are not permitted to take probiotics during the course of immunotherapy treatment;
• •4. Use of natural supplements including prebiotics. Prebiotics must be discontinued a minimum of 2 weeks before CC administration and patients are not permitted to take other prebiotics during the course of immunotherapy treatment;
• •5. Use of antibiotics within 2 weeks of enrollment in the study;
• •a. If a patient requires antibiotics during CC treatment, they are permitted to stay on the study.
• •6. Expected to require any other form of systemic anti-neoplastic therapy while on study (radiation therapy is permitted);
• •7. In the last year, has a known history of a malignancy requiring anti-neoplastic treatment.
• •a. NOTE: This time requirement does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers;
• •8. Symptomatic central nervous system (CNS) metastases
• •9. Leptomeningeal involvement (leptomeningeal enhancement on MRI/CT imaging and/or positive CSF cytology);
• •10. Has an uncontrolled autoimmune disease that requires systemic steroids or immunosuppressive agents;
• •a. Patients with vitiligo, type I diabetes, well controlled hypothyroidism due to Hashimoto disease, resolved childhood asthma/atopy are permitted to enroll.
• •11. A history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• •12. Has serious concomitant illnesses, such as: impaired cardiovascular function or clinically significant cardiovascular disease (uncontrolled congestive heart failure requiring treatment (NYHA grade \> 3), uncontrolled hypertension, acute myocardial cardiac ischemia or unstable angina \< 2 months prior to study entry, and severe cardiac arrhythmia), active inflammatory bowel disorders.
• •13. Active kidney disease/severe chronic kidney or liver disease or hematological blood test alteration that would preclude safe administration of chemotherapy at the discretion of the sponsor.
• •14. Has an active infection requiring systemic therapy;
• •15. Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
• •a. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. COVID-19 vaccinations are not live vaccinations and are allowed.
• •16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• •17. Known life-threatening or severe allergy to CC at the discretion of the sponsor