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

16 aprile 2021 aggiornato da: Celgene

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Study population included subjects who had progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.

The dose escalation part of the study was designed to explore three dose levels of CC-122 to identify the recommended phase 2 dose (RP2D) to be used in the expansion phase. Approximately 20 subjects were to be enrolled in the dose escalation part of the study. Subjects could be treated for up to 2 years, or until progression of disease, unacceptable toxicity, subject/physician decision, withdrawal of consent, death. Safety follow up until 28 days after CC122 treatment and 90 days after nivolumab treatment. RECIST 1.1 criteria was used to determine response. Survival follow up until death, withdrawal of consent, or the study closes. Subjects were permitted to continue treatment beyond progression (TBP) if they continue to meet protocol criteria, had stable performance status, had clinical benefit, other treatment options were discussed. A separate ICF was signed to continue TBP.

During the dose escalation phase, CC-122 was administered orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle. Once the RP2D for dosing of CC-122 in combination with nivolumab was defined, expansion (Phase 2) would start. A modified 3+3 dose escalation design was used to identify the initial toxicity of the combination. Up to six subjects were concurrently enrolled into a dose level. Decisions as to which dose level to enroll a new subject were 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. A Safety Review Committee (SRC) comprised of investigators participating in the study made dose escalation decisions based on these criteria.

After completion of the Dose Escalation Phase, the Dose Expansion Phase of the study did not proceed due to the changing landscape in the treatment of HCC. There were no additional safety concerns or safety signals identified in the dose escalation phase of the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Marseille Cedex 9, Francia, 13273
        • Institut Paoli Calmettes
      • Rennes, Francia, 35200
        • Centre Eugène Marquis
      • Toulouse Cedex, Francia, 31059
        • Institut Universitaire du Cancer IUCT - Oncopole
      • Villejuif CEDEX, Francia, 94805
        • Institut Gustave Roussy Hematologie
  • Italia
      • Milan, Italia, 20089
        • IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
      • Pavia, Italia, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Roma, Italia, 144
        • Istituto Nazionale Tumori Regina Elena
  • Spagna
      • Barcelona, Spagna, 8035
        • Hospital Universitario Vall d Hebron
      • Madrid, Spagna, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spagna, 28041
        • Hospital 12 de Octubre
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90095-1752
        • UCLA Division of Hematology Oncology
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida
    • New York
      • New York, New York, Stati Uniti, 10016
        • NYU Langone Medical Center
    • Texas
      • Dallas, Texas, Stati Uniti, 75251
        • Mary Crowley Cancer Research

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Droga: Nivolumab
Droga: CC-122

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Dose Limiting Toxicities (DLTs)
Lasso di tempo: 28 days

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

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)
Lasso di tempo: up to 2 years
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease Control Rate (DCR) by RECIST 1.1
Lasso di tempo: up to 2 years
DCR 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) or stable disease (SD).
up to 2 years
Duration of Response (DoR) by RECIST 1.1
Lasso di tempo: up to 2 years
Duration of response is measured from the date the criterion is first met for CR/PR using RECIST 1.1 rules (whichever is first recorded) until the first date when progressive disease using RECIST 1.1 is documented or death occurred.
up to 2 years
Progression-Free Survival (PFS) by RECIST 1.1
Lasso di tempo: up to 2 years

Progression-Free Survival (PFS) is defined as the time from the first dose date of study drug until tumor progression or death, whichever occurs first. A subject who has neither progressed nor died or who progresses or dies after an extended lost-to-follow up time (two or more missed assessments) is censored on the date of last adequate tumor assessment. Subjects without valid baseline or post-baseline tumor assessments are censored on their first dose date.

Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data.
up to 2 years
Overall Survival (OS) by RECIST 1.1
Lasso di tempo: up to 2 years

Overall Survival (OS) is measured as the time from the first dose of study drug to death from any cause. Participants who have no death reported are censored at the last contact date the participant is known to be alive.

Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data.
up to 2 years
Time to Progression (TTP) by RECIST 1.1
Lasso di tempo: up to 2 years

Time to Progression (TTP) is defined as the time from the first dose date of study drug until tumor progression; TTP does not include death. The censoring rules are the same as PFS except that deaths without progression are censored at last adequate tumor assessment.

Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data.
up to 2 years
Maximum Observed Concentration (Cmax)
Lasso di tempo: 28 days
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
28 days
Area Under the Concentration Time Curve (AUC)
Lasso di tempo: 28 days
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
28 days
Time to Maximum Concentration (Tmax)
Lasso di tempo: 28 days
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
28 days
Terminal Half-life (T-HALF)
Lasso di tempo: 28 days
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
28 days
Apparent Volume of Distribution (Vz/F)
Lasso di tempo: 28 days
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
28 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Celgene

Investigatori

  • Direttore dello studio: Akshay Patel, Celgene Corporation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 settembre 2016

Completamento primario (Effettivo)

27 marzo 2020

Completamento dello studio (Effettivo)

27 marzo 2020

Date di iscrizione allo studio

Primo inviato

4 agosto 2016

Primo inviato che soddisfa i criteri di controllo qualità

4 agosto 2016

Primo Inserito (Stima)

9 agosto 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 aprile 2021

Ultimo verificato

1 aprile 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CC-122-HCC-002
  • 2016-000112-15 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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