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A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib) | Clinical Trials | Clareo Health

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

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

NCT02900664•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed Description

This was a Phase Ib, multi-center, open-label study, to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 in combination with canakinumab, CJM112, trametinib and EGF816 and single agent (s.a.) canakinumab in subjects with Triple Negative Breast Cancer (TNBC), Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC). The study comprised a dose escalation part for combination treatments only, followed by a dose expansion part.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.

Exclusion 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
+25 more criteria

Locations (23)

Sidney Kimmel Comprehensive Cancer Center SC-3

Baltimore, Maryland, United States

Dana Farber Cancer Center

Boston, Massachusetts, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Wilrijk, Belgium

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Lyon, France

Novartis Investigative Site

Paris, France

Key Dates

Start Date

August 23, 2016

Primary Completion Date

March 17, 2021

Completion Date

March 17, 2021

Last Updated

March 29, 2022

Enrollment

283

ACTUAL participants

Conditions

Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma

Interventions

PDR001

BIOLOGICAL

ACZ885

BIOLOGICAL

CJM112

BIOLOGICAL

TMT212

DRUG

EGF816

DRUG