A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

Completed · Phase 1

Conditions studied: Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma

In brief

The purpose of this study was to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

Key facts

Study ID

NCT02890069

Run by

Novartis Pharmaceuticals

People needed

298

Starts

2016-10-14

Expected to finish

2022-02-22

Last updated by the study team

2023-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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• RCC
• 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.

You may not qualify if…

• Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy within prior 2 weeks.
• Patients with known hypersensitivity to any of the components of an investigational treatment will be excluded from participation in the corresponding arm but are eligible for participation in other study arm; Patients that have a history of hypersensitivity to rapamycin derivatives will be excluded from participation in the everolimus arm
• History of or current drug-induced interstitial lung disease or pneumonitis grade ≥2
• 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 washout period is 6 weeks; prior immunotherapy - washout is 4 weeks
• Active infection requiring systemic antibiotic therapy.
• Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids or treatment with low, stable dose of steroid (<10 mg/day prednisone or equivalent) for stable CNS metastatic disease.
• 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.
• Use of hematopoietic colony stimulating growth factors </= 3 weeks prior to first dose
• 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-

Where it is running

• UCLA Santa Monica Hematology / Oncology SC — Santa Monica, California, United States
• Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Regents of the University of Michigan — Ann Arbor, Michigan, United States
• Washington University Medical School SC — St Louis, Missouri, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• UT Health San Antonio Mays Cancer Center — San Antonio, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Novartis Investigative Site — Jena, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Leiden, Netherlands
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Utrecht, Netherlands
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Pamplona, Navarre, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Taipei, Taiwan
• Novartis Investigative Site — Sutton, Surrey, United Kingdom
• Novartis Investigative Site — Manchester, United Kingdom
• Novartis Investigative Site — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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