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TERMINATEDPHASE1

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

A Phase 1b Study of the Selective HDAC6 Inhibitor ACY-241 in Combination With Nivolumab in Patients With Unresectable Non-Small Cell Lung Cancer

NCT02635061•Celgene

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

Locations (1)

Local Institution - 350

Boston, Massachusetts, United States

Key Dates

Start Date

August 25, 2016

Primary Completion Date

January 22, 2024

Completion Date

January 22, 2024

Last Updated

May 7, 2024

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

ACY-241

DRUG

Nivolumab

DRUG

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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