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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Celgene
Study ID
NCT02859324
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 20, 2016
Status verified
Apr 2021
Primary completion
Mar 27, 2020
Completion
Mar 27, 2020

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCLA Division of Hematology OncologyLos AngelesCalifornia90095-1752-
University of FloridaGainesvilleFlorida32610-
NYU Langone Medical CenterNew YorkNew York10016-
Mary Crowley Cancer ResearchDallasTexas75251-

Find similar trials in Los Angeles, CA

By research site
UCLA Division of Hematology Oncology· Los Angeles, CAUniversity of Florida· Gainesville, FLNYU Langone Medical Center· New York, NYMary Crowley Cancer Research· Dallas, TX

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