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A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589)

NCT02890069•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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
+27 more criteria

Locations (25)

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

Key Dates

Start Date

October 14, 2016

Primary Completion Date

February 22, 2022

Completion Date

February 22, 2022

Last Updated

January 11, 2023

Enrollment

298

ACTUAL participants

Conditions

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

Interventions

PDR001

BIOLOGICAL

LCL161

DRUG

Everolimus

DRUG

Panobinostat

DRUG

QBM076

DRUG

HDM201

DRUG