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A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)

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ClinicalTrials.gov Identifier: NCT02859324
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: CC-122 Drug: Nivolumab Phase 1 Phase 2

Detailed Description:

Subjects will have received either none or no more than 2 previous systemic therapies. The dose escalation part of the study will explore 1 or more dose levels of CC-122 in combination with nivolumab using a modified dose escalation (3+3) design, followed by an expansion part once the recommended Phase 2 dose (RP2D) is defined.

A modified 3+3 dose escalation design will be used to identify the initial toxicity of the combination. Up to six subjects will be concurrently enrolled into a dose level. Decisions as to which dose level to enroll a new subject will be based on the number of subjects enrolled and evaluable, the number of subjects experiencing DLTs, and the number of subjects enrolled but who are not yet evaluable for toxicity in the current cohort at the time of new subject entry.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, MultiCenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability and Preliminary Efficacy of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellullar Carcinoma (HCC) Following First Line Treatment Failure
Actual Study Start Date : September 20, 2016
Estimated Primary Completion Date : August 18, 2021
Estimated Study Completion Date : August 18, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: CC-122 with Nivolumab
CC-122 orally 5/7 days with nivolumab Intravenously (IV) 3mg/kg every 2 weeks. Cohorts of up to 6 subjects per dose level until Recommended Phase 2 dose (RP2D).
Drug: CC-122
Drug: Nivolumab



Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT

  2. Adverse Events (AEs) [ Time Frame: Up to 27 months ]
    Number of participants with adverse events

  3. Overall Response Rate (ORR) - Phase 2 [ Time Frame: Up to 2 years ]
    The combined incidence of complete response (CR) + partial response (PR), by investigator assessment of response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1


Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: Up to 2 years ]
    The combined incidence of CR, PR and stable disease by investigator assessment using RECIST 1.1.

  2. Duration of response (DoR) [ Time Frame: Up to 2 years ]
    Duration from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date of recurrent or progressive disease using RECIST 1.1.

  3. Progression free survival (PFS) [ Time Frame: Up to 2 years ]
    Number of participants who survive without tumor progression using RECIST 1.1and time from the first dose date until the date of tumor progression or death, whichever occurs first.

  4. Overall survival (OS) [ Time Frame: Up to 2 years ]
    Number of participants who survive and the time from the first dose date until the date of death from any cause.

  5. Time to progression (TTP) [ Time Frame: Up to 2 years ]
    Time from the first dose date until the date of tumor progression using RECIST 1.1 (not including death).

  6. Pharmacokinetic - Cmax [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]
    Maximum observed concentration

  7. Pharmacokinetic - AUC [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]
    Area under the concentration time curve

  8. Pharmacokinetic - Tmax [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]
    Time to maximum concentration

  9. Pharmacokinetic - t1/2 [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]
    Terminal half-life

  10. Pharmacokinetic - CL/F [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]
    Apparent total body clearance

  11. Pharmacokinetic - Vz/F [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]
    Apparent volume of distribution



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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:

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
  • Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) Guidelines.
  • Subjects who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
  • Subject has at least one measurable lesion according to RECIST 1.1.
  • Subject has a life expectancy of ≥ 12 weeks
  • Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Subject has adequate hematologic function and adequate hepatic function at screening

Exclusion Criteria:

  • The presence of any of the following will exclude a subject from enrollment:
  • Subject has received more than 2 previous systemic therapies for Hepatocellular carcinoma (HCC).
  • Subject has received previous treatment with any anti-PD-1 (Programmed death 1) or anti-PD-L1 (PD-1 ligand receptor) antibody

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): NCT02859324


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, California
UCLA Division of Hematology Oncology Recruiting
Los Angeles, California, United States, 90095-1752
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75251
France
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, France, 13273
Centre Eugene Marquis Recruiting
Rennes, France, 35200
Institut Universitaire du Cancer IUCT - Oncopole Recruiting
Toulouse Cedex, France, 31059
Institut G. Roussy Recruiting
Villejuif, France, 94800
Italy
IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center Recruiting
Milan, Italy, 20089
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Istituto Nazionale Tumori Regina Elena Recruiting
Roma, Italy, 144
Spain
Hospital Universitario Vall D Hebron Recruiting
Barcelona, Spain, 8035
Hospital Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Sponsors and Collaborators
Celgene
Investigators
Study Director: Alfredo Romano, MD, PhD Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02859324     History of Changes
Other Study ID Numbers: CC-122-HCC-002
2016-000112-15 ( EudraCT Number )
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Celgene:
CC-122
Nivolumab
Hepatocellular Carcinoma
Phase 1/2
Safety

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs