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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-25

Study Completion Date

2024-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma

NCT03467360

Small Cell Lung Cancer

RECRUITING PHASE1

Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)

NCT00418743

Small Cell Lung Cancer

UNKNOWN

Study of 225Ac-ABD147 to Establish Optimal Dose in Patients With SCLC and LCNEC of the Lung That Previously Received Platinum-based Chemotherapy

NCT06736418

Small-Cell Lung Cancer (SCLC) Large Cell Neuroendocrine Carcinoma of the Lung

RECRUITING PHASE1

Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer

NCT02521051

Non-Small Cell Lung Cancer (NSCLC)

TERMINATED PHASE1/PHASE2

S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00085501

Lung Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACY-241 in combination with nivolumab

Group Type EXPERIMENTAL

ACY-241

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACY-241

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Opdivo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No