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Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

25 ottobre 2017 aggiornato da: Tina Cheng, AHS Cancer Control Alberta

Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2 clinical studies.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. Patients may have received prior chemotherapy or biological therapy for the treatment of advanced disease. Twenty-nine patients will be enrolled. Patients may have either measurable disease or non-measurable disease.

Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity. Each cycle is defined as a 90 +/- 4 days period. Patients should be weighed within 10 days prior to each cycle and the administered dose of CP-675,206 should be recalculated.

Patients who complete 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 4 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma. Patients with clinical benefit may be considered for additional dosing if evidence emerges supporting ongoing maintenance therapy.

Tumor assessments will be done every 3 months. All patients with objective tumor response must have additional scans scheduled 4-6 weeks after the criteria for response are first met in order to confirm the response. Additional scans will be done if clinically indicated. Survival will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206. The follow up time may be adjusted based on ongoing studies using CP-675,206 for melanoma.

An exploratory study will be conducted to identify micro environmental features in the tumor that are permissive of tumor immunity (i.e: those associated with a "response" to anti-CTLA4) and to assess whether anti-CTLA4 causes peripheral mobilization of immunomodulatory inflammatory cells.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

11

Fase

  • Fase 2

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

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:

  • Histologically confirmed uveal melanoma including choroidal melanoma, iris melanoma, and ciliary body melanoma
  • Patients may either have measurable disease or non-measurable disease.
  • Biopsies from a readily accessible site of disease on study enrollment are mandatory in principle. Waivers will be granted if there are no accessible lesions. The collection of a representative block of the diagnostic tumour tissue (if available) is mandatory.
  • ECOG performance status of 0 or 1
  • Age 18 years or older
  • Adequate bone marrow, hepatic, and renal function determined within 14 days prior to registration, defined as:
  • Serum lactic acid dehydrogenase (LDH) </= 1.5 x ULN.
  • Alkaline phosphatase (ALP) </= 2 x ULN.
  • No weight loss >/= 10% in the proceeding 4 weeks.
  • CT scan of the brain with contrast or MRI of the brain within 28 days of registration showing no evidence of brain metastases.
  • Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
  • Females of childbearing potential and males who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator.

Exclusion Criteria:

  • Melanoma of cutaneous, mucosal or conjunctival origin.
  • History of brain or leptomeningeal metastases.
  • Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other immunotherapy.
  • History of chronic inflammatory or autoimmune disease
  • History of uveitis or melanoma-associated retinopathy.
  • History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
  • History of hepatitis due to Hepatitis B virus or Hepatitis C virus

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: Open Label CP-675,206
Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity.
Droga: CP-675,206
Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of ever 90 cycle for up to 4 cycles or until progression or intolerance of toxicity. Tumor assessments will be done ever 3 months. Additional scans will be done if clinically indicated.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival at 6 months after initiation of CP-675,206
Lasso di tempo: 6 months
A 6-month progression free survivor will be defined as a patient who is alive and who has not progressed at 6 months or more post treatment.
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective tumor response
Lasso di tempo: overall
Duration of Objective response (CR or PR) for responding patients will be measured from the date of registration to the date of progression or death due to progressive disease, whichever occurs first. In addition, the Duration of Complete Response will be measured from the date that a CR was first documented to the date of progression or death due to progressive disease, whichever occurs first.
overall
Durable response
Lasso di tempo: 6 or more months
Durable response is defined as an objective tumor response that last 6 or more months
6 or more months
Median survival and overall survival
Lasso di tempo: overall
• Overall Survival (OS) is defined as the time from the date of registration to date of death by any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient was known to be alive.
overall
Adverse events and tolerability
Lasso di tempo: overall
Following the first dose, adverse events should be continuously assessed and documented during the study reporting period. Adverse events will be followed up to and including the End of Treatment visit. Additionally, all adverse events with a causal relationship to the study drug must be followed until the event and its sequalae have resolved, returned to baseline, been deemed irreversible, or until the patient dies.
overall

Collaboratori e investigatori

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

Sponsor

AHS Cancer Control Alberta

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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)

17 agosto 2009

Completamento primario (Effettivo)

8 agosto 2017

Completamento dello studio (Effettivo)

8 agosto 2017

Date di iscrizione allo studio

Primo inviato

15 dicembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

16 dicembre 2009

Primo Inserito (Stima)

17 dicembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 ottobre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 ottobre 2017

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TBCC 905001

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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