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

NCT02635061 | Terminated Phase 1 FDA Drug

• 1 other identifier: ACE-ST-203
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  one to two years

• recommended Phase 2 dose (RP2D) of ACY 241 in combination with nivolumab

  one to two years

Secondary Outcomes (2)

• preliminary antitumor activity of ACY 241 in combination with nivolumab

  one to two years

• Maximum Plasma Concentration [Cmax] of ACY 241 in combination with nivolumab on biomarkers in peripheral blood and tumor tissue

  one to two years

Study Arms (1)

ACY-241 in combination with nivolumab

EXPERIMENTAL

Drug: ACY-241; Drug: Nivolumab

Interventions

ACY-241 DRUG

Specified dose on specified days

ACY-241 in combination with nivolumab

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo

ACY-241 in combination with nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to understand and voluntarily sign an informed consent form (ICF).
• Must be ≥ 18 years of age at the time of signing the ICF.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• 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.
• Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and Immune related Response Criteria (irRC).
• Life expectancy \> 12 weeks.
• Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
• Willingness to have pre treatment and on treatment tumor biopsies.
• 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.
• Male patients should be willing to use barrier contraceptive (ie, condoms) until 3 months after last study drug is taken.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent.
• 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.
• Pregnant or lactating females.
• Patients with uncontrolled brain metastases. Existing brain metastases must have been previously treated and currently stable.
• 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.
• Previous therapy with histone deacetylase (HDAC) inhibitor and/or anti PD 1, anti PD L1, or anti CTLA4 immunotherapy.
• 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
• 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).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 350

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Awad MM, Le Bruchec Y, Lu B, Ye J, Miller J, Lizotte PH, Cavanaugh ME, Rode AJ, Dumitru CD, Spira A. Selective Histone Deacetylase Inhibitor ACY-241 (Citarinostat) Plus Nivolumab in Advanced Non-Small Cell Lung Cancer: Results From a Phase Ib Study. Front Oncol. 2021 Sep 6;11:696512. doi: 10.3389/fonc.2021.696512. eCollection 2021.

  PMID: 34552864 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

citarinostat; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ileana Elias, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 18, 2015
• Study Start: August 25, 2016
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)