- Written informed consent prior to any procedure
- Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant to SOC, or for whom no standard therapy exists. Patients must fit into one of the following groups:
• CRC •NSCLC • TNBC
- ECOG ≤ 2
- Patient must have a site of disease for biopsy, and be a candidate for tumor biopsy according to the institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study.
- Prior therapy with PD-1/PDL-1 inhibitors is allowed provided any toxicity attributed to prior PD-1- or PD-L1-directed therapy did not lead to discontinuation of therapy.
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy within prior 2 weeks.
- History of severe hypersensitivity reactions to other mAbs.
- Out of range lab values as defined in protocol
- Impaired cardiac function or clinically significant cardiac disease
- Active, known or suspected autoimmune disease
- Human Immunodeficiency Virus (HIV), or active Hepatitis C (HCV) virus. Escalation: active Hepatitis B (HBV); Expansion: Patients with Chronic HBV currently on medication will not be excluded.
- Impairment of gastrointestinal (GI) function
- Malignant disease, other than that being treated in this study
- Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and CTLA-4 antagonists, washout period is 6 weeks.
- Active infection requiring systemic antibiotic therapy.
- Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids.
- Patients receiving systemic treatment with any immunosuppressive medication.
- Major surgery within 2 weeks of the first dose of study treatment
- Radiotherapy within 2 weeks of the first dose of study drug
- Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
- Presence of ≥ CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ CTCAE grade 3) due to prior therapy.
Additional exclusion criteria for PDR001/LCL161
- Patients requiring medications metabolized through CYP3A4/5 and have a narrow therapeutic index or medications that are CYP3A4 substrates that cause QT prolongation
- Patients requiring treatment with strong CYP2C8 inhibitors
Additional exclusion criteria for PDR001/Everolimus
- Patients requiring treatment with moderate CYP3A4 inhibitors
- Patients requiring treatment with a strong CYP3A4 inhibitor or inducer
Additional exclusion criteria for PDR001/Panobinostat-
- Patient who received DAC inhibitors
- Patient needing valproic acid during the study or within 5 days prior to first dose
- Patients requiring medications that are sensitive CYP2D6 substrates or are anti-arrhythmic drugs/QT-prolonging drugs
- Patients requiring a strong inhibitor or inducer of CYP3A4
- Clinically significant, uncontrolled heart disease and/or recent cardiac event within 6 months prior to study
- Unresolved diarrhea ≥ CTCAE grade 2 or a medical condition associated with chronic diarrhea
- Taking medications with QT prolongation risk or interval or inducing Torsade de pointes
Other protocol-defined inclusion exclusion criteria may apply.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|