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CompletedPhase 1NCT02900664
Official study title

A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Study summary

The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPDR001 and ACZ885

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 29, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Biological: PDR001; Biological: ACZ885; Biological: CJM112; Drug: TMT212; Drug: EGF816
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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 standard therapy, and for whom no effective therapy is available. Patients must fit into one of the following groups:
  • Colorectal cancer (CRC) (not mismatch repair deficient by local assay including PCR and/or immunohistochemistry)
  • Non-small cell lung cancer (NSCLC) (adenocarcinoma)
  • Triple Negative Breast Cancer (TNBC) (D
  • ECOG Performance Status ≤ 2
  • Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at baseline, 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.
  • Written informed consent must be obtained prior to any screening procedures other than procedures performed as part of standard of care.
Reasons someone may not be able to joinExclusion criteria
  • Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks.
  • History of severe hypersensitivity reactions to other monoclonal antibodies.
  • Out of range laboratory values for measures of hepatic and renal function, electrolytes and blood counts
  • Impaired cardiac function or clinically significant cardiac disease.
  • Patients with active, known or suspected autoimmune disease.
  • Human Immunodeficiency Virus infection at screening.
  • Escalation part: Active Hepatitis B (HBV) or Hepatitis C (HCV) virus infection at screening. Expansion part: Patients with active HBV or HCV are excluded, excepting those patients undergoing treatment for HBV or HCV.
  • Malignant disease, other than that being treated in this study.
  • Recent systemic anti-cancer therapy
  • Active infection requiring systemic antibiotic therapy.
  • Patients requiring chronic treatment with systemic steroid therapy, other than replacement dose steroids in the setting of adrenal insufficiency or treatment with low, stable dose of steroid (\<10mg/ day prednisone or equivalent) for stable CNS metastatic disease.
  • Patients receiving systemic treatment with any immunosuppressive medication, excepting the above
  • Use of any live vaccines against infectious diseases (e.g. influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
  • Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
  • Presence of ≥ CTCAE grade 2 toxicity (except alopecia and ototoxicity, which are excluded if ≥ CTCAE grade 3) due to prior cancer therapy.
  • Recent use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF) Additional

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Sidney Kimmel Comprehensive Cancer Center SC-3Baltimore, Maryland
  • Dana Farber Cancer CenterBoston, Massachusetts
  • Sarah Cannon Research InstituteNashville, Tennessee
  • University of Texas MD Anderson Cancer CenterHouston, Texas
  • Novartis Investigative SiteBrussels
  • Novartis Investigative SiteWilrijk
  • Novartis Investigative SiteToronto, Ontario
  • Novartis Investigative SiteMontreal, Quebec
  • Novartis Investigative SiteLyon
  • Novartis Investigative SiteParis
  • Novartis Investigative SiteToulouse
  • Novartis Investigative SiteVillejuif

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 29, 2022. Always confirm current availability with the study team.

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