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 : Active, not recruiting
First Posted : August 9, 2016
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: CC-122 Drug: Nivolumab||Phase 1 Phase 2|
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)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||March 1, 2020|
|Estimated Study Completion Date :||March 1, 2020|
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).
- Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]Number of participants with a DLT
- Adverse Events (AEs) [ Time Frame: Up to 27 months ]Number of participants with adverse events
- 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
- 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.
- 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.
- 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.
- 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.
- 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).
- Pharmacokinetic - Cmax [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]Maximum observed concentration
- 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
- Pharmacokinetic - Tmax [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]Time to maximum concentration
- Pharmacokinetic - t1/2 [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]Terminal half-life
- Pharmacokinetic - CL/F [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]Apparent total body clearance
- Pharmacokinetic - Vz/F [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post dose on Cycle 1 Day 15 ]Apparent volume of distribution
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
|United States, California|
|UCLA Division of Hematology Oncology|
|Los Angeles, California, United States, 90095-1752|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|United States, Texas|
|Mary Crowley Cancer Research|
|Dallas, Texas, United States, 75251|
|Institut Paoli Calmettes|
|Marseille Cedex 9, France, 13273|
|Centre Eugene Marquis|
|Rennes, France, 35200|
|Institut Universitaire du Cancer IUCT - Oncopole|
|Toulouse Cedex, France, 31059|
|Institut G. Roussy|
|Villejuif, France, 94800|
|IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center|
|Milan, Italy, 20089|
|Fondazione IRCCS Policlinico San Matteo|
|Pavia, Italy, 27100|
|Istituto Nazionale Tumori Regina Elena|
|Roma, Italy, 144|
|Hospital Universitario Vall D Hebron|
|Barcelona, Spain, 8035|
|Hospital Ramon y Cajal|
|Madrid, Spain, 28034|
|Hospital 12 de Octubre|
|Madrid, Spain, 28041|
|Study Director:||Alfredo Romano, MD, PhD||Celgene Corporation|