NCT02859324

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Typical duration for phase_1

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 11, 2021

Completed
Last Updated

May 11, 2021

Status Verified

April 1, 2021

Enrollment Period

3.5 years

First QC Date

August 4, 2016

Results QC Date

March 17, 2021

Last Update Submit

April 16, 2021

Conditions

Carcinoma, Hepatocellular

Keywords

CC-122NivolumabHepatocellular CarcinomaPhase 1/2Safety

Outcome Measures

Primary Outcomes (3)

  • Incidence of Dose Limiting Toxicities (DLTs)

    During dose escalation, the DLT assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. A DLT is defined as any of the following toxicities occurring within the DLT assessment window unless the event can clearly be determined to be unrelated to the drug.

    28 days

  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

    During dose escalation, the TEAE phase 1 assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. Number of participants who experienced a TEAE during the course of the study.

    From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years)

  • Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).

    up to 2 years

Secondary Outcomes (10)

  • Disease Control Rate (DCR) by RECIST 1.1

    up to 2 years

  • Duration of Response (DoR) by RECIST 1.1

    up to 2 years

  • Progression-Free Survival (PFS) by RECIST 1.1

    up to 2 years

  • Overall Survival (OS) by RECIST 1.1

    up to 2 years

  • Time to Progression (TTP) by RECIST 1.1

    up to 2 years

  • +5 more secondary outcomes

Study Arms (1)

CC-122 with Nivolumab

EXPERIMENTAL

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-122Drug: Nivolumab

Interventions

CC-122DRUG
CC-122 with Nivolumab
NivolumabDRUG
CC-122 with Nivolumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

UCLA Division of Hematology Oncology

Los Angeles, California, 90095-1752, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Centre Eugene Marquis

Rennes, 35200, France

Location

Institut Universitaire du Cancer IUCT - Oncopole

Toulouse, 31059, France

Location

Institut Gustave Roussy Hematologie

Villejuif, 94805, France

Location

IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

Milan, 20089, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Istituto Nazionale Tumori Regina Elena

Roma, 144, Italy

Location

Hospital Universitario Vall D Hebron

Barcelona, 8035, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dioneNivolumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please email:

Study Officials

  • Akshay Patel

    Celgene Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

August 4, 2016

First Posted

August 9, 2016

Study Start

September 20, 2016

Primary Completion

March 27, 2020

Study Completion

March 27, 2020

Last Updated

May 11, 2021

Results First Posted

May 11, 2021

Record last verified: 2021-04

Locations

US(4)FR(4)IT(3)ES(3)