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Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02635061
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
Determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of ACY 241 in combination with nivolumab.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: ACY-241 Drug: Nivolumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of the Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer
Actual Study Start Date : August 25, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: ACY-241 in combination with nivolumab Drug: ACY-241
Drug: Nivolumab
Other Name: Opdivo




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: one to two years ]
  2. recommended Phase 2 dose (RP2D) of ACY 241 in combination with nivolumab [ Time Frame: one to two years ]

Secondary Outcome Measures :
  1. preliminary antitumor activity of ACY 241 in combination with nivolumab [ Time Frame: one to two years ]
  2. Maximum Plasma Concentration [Cmax] of ACY 241 in combination with nivolumab on biomarkers in peripheral blood and tumor tissue [ Time Frame: one to two years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be able to understand and voluntarily sign an informed consent form (ICF).
  2. Must be ≥ 18 years of age at the time of signing the ICF.
  3. Must be able to adhere to the study visit schedule and other protocol requirements.
  4. Patients must have histologically confirmed unresectable NSCLC for which nivolumab is clinically appropriate. Patients must have had one line of prior therapy and have progressed or have discontinued due to toxicity.
  5. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and Immune related Response Criteria (irRC).
  6. Life expectancy > 12 weeks.
  7. Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  8. Willingness to have pre treatment and on treatment tumor biopsies.
  9. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female patients of childbearing potential must agree to use adequate contraceptive measures until 3 months after the last study drug is taken. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.
  10. Male patients should be willing to use barrier contraceptive (ie, condoms) until 3 months after last study drug is taken.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent.
  2. Any serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient nonevaluable, put the patient's safety at risk, or prevent the patient from following the study requirements.
  3. Pregnant or lactating females.
  4. Patients with uncontrolled brain metastases. Existing brain metastases must have been previously treated and currently stable.
  5. Patients who have had chemotherapy within 14 days before entering the study or those who have not recovered from AEs to ≤ Grade 1 due to agents administered more than 14 days earlier.
  6. Previous therapy with histone deacetylase (HDAC) inhibitor and/or anti PD 1, anti PD L1, or anti CTLA4 immunotherapy.
  7. Any of the following laboratory abnormalities:

    • ANC < 1,500/µL
    • Platelet count < 100,000/µL
    • Hematologic growth factors are not allowed at Screening or during the first cycle of treatment
    • Hemoglobin < 9 g/dL (< 5.5 mmol/L; previous red blood cell transfusion is permitted)
    • Creatinine > 1.5 × upper limit of normal (ULN)
    • AST or ALT > 2.5 × ULN. For patients with liver metastasis AST or ALT > 5 × ULN
    • Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
  8. Corrected QT interval (QTc) using Fridericia's formula (QTcF) value > 480 msec at Screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at Screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG).
  9. Congestive heart failure (New York Heart Association Class III or IV), myocardial infarction within 12 months before starting study treatment, or unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
  10. Patients with chronic autoimmune disease(s) requiring systemic immunosuppression.
  11. Positive human immunodeficiency virus, hepatitis B virus, and hepatitis C virus infection.
  12. Patients who received any of the following within the 14 days before initiating study treatment: major surgery, radiation therapy, and/or systemic therapy (standard or an investigational or biological anticancer agent).
  13. Current enrollment in another clinical study involving treatment and/or is receiving an investigational agent for any reason, or use of any investigational agents within 14 days of initiating study treatment.
  14. Incidence of gastrointestinal disease that may significantly alter the absorption of ACY 241.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635061


Contacts
Contact: Caroline Labe 617-710-7065 clabe@celgene.com

Locations
United States, California
University of Southern California Completed
Los Angeles, California, United States, 90033
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Celgene
Investigators
Study Director: Ileana Elias, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02635061     History of Changes
Other Study ID Numbers: ACE-ST-203
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs