- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01034787
Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alberta
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Calgary, Alberta, Kanada, T2N4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression-free survival at 6 months after initiation of CP-675,206
Tidsram: 6 months
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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.
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective tumor response
Tidsram: overall
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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.
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overall
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Durable response
Tidsram: 6 or more months
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Durable response is defined as an objective tumor response that last 6 or more months
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6 or more months
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Median survival and overall survival
Tidsram: overall
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• 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.
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overall
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Adverse events and tolerability
Tidsram: overall
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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.
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overall
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- Rietschel P, Panageas KS, Hanlon C, Patel A, Abramson DH, Chapman PB. Variates of survival in metastatic uveal melanoma. J Clin Oncol. 2005 Nov 1;23(31):8076-80. doi: 10.1200/JCO.2005.02.6534.
- Bedikian AY, Legha SS, Mavligit G, Carrasco CH, Khorana S, Plager C, Papadopoulos N, Benjamin RS. Treatment of uveal melanoma metastatic to the liver: a review of the M. D. Anderson Cancer Center experience and prognostic factors. Cancer. 1995 Nov 1;76(9):1665-70. doi: 10.1002/1097-0142(19951101)76:93.0.co;2-j.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TBCC 905001
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Kliniska prövningar på Uveal melanom
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)AvslutadIris melanom | Medium/Large Size Posterior Uveal Melanom | Steg IIA Uveal melanom | Steg IIB Uveal melanom | Steg IIIA Uveal melanom | Steg IIIB Uveal melanom | Steg IIIC Uveal melanomFörenta staterna
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)AvslutadSteg IV Uveal melanom | Steg IIIA Uveal melanom | Steg IIIB Uveal melanom | Steg IIIC Uveal melanomFörenta staterna
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Alliance for Clinical Trials in OncologyIndragenMetastaserande Uveal melanom | Avancerat Uveal melanom | Inoperabelt Uveal melanom
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National Cancer Institute (NCI)AvslutadIris melanom | Steg IV Uveal melanom | Medium/Large Size Posterior Uveal Melanom | Återkommande Uveal melanom | Okulärt melanom med extraokulär förlängning | Liten storlek bakre uveal melanomFörenta staterna, Kanada
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaAvslutadSteg IV Hudmelanom | Återkommande melanom | Stadium IIIB Hudmelanom | Stadium IIIC Hudmelanom | Slemhinnemelanom | Steg IV Uveal melanom | Stadium IIIA Hudmelanom | Steg IIIA Uveal melanom | Steg IIIB Uveal melanom | Steg IIIC Uveal melanom | Återkommande Uveal melanomFörenta staterna
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Udai KammulaRekryteringUveal neoplasmer | Melanom, UvealFörenta staterna
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Vastra Gotaland RegionMerck Sharp & Dohme LLC; Syndax PharmaceuticalsAvslutadEffektstudie av Pembrolizumab med Entinostat för att behandla metastaserande melanom i ögat (PEMDAC)Metastaserande Uveal melanomSverige
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National Cancer Institute (NCI)AvslutadSteg IV kutant melanom AJCC v6 och v7 | Återkommande melanom | Steg IIIC kutant melanom AJCC v7 | Slemhinnemelanom | Iris melanom | Steg IIIA kutant melanom AJCC v7 | Steg IIIB kutant melanom AJCC v7 | Steg IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Återkommande Uveal melanom | Steg... och andra villkorFörenta staterna
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Jose Lutzky, MDBristol-Myers Squibb; United States Department of DefenseAktiv, inte rekryterandeMetastaserande Uveal melanomFörenta staterna
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Thomas Jefferson UniversityVerastem, Inc.Aktiv, inte rekryterandeMetastaserande Uveal melanomFörenta staterna
Kliniska prövningar på CP-675,206
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Azienda Ospedaliera Universitaria SeneseMedImmune LLCOkändMalignt mesoteliomItalien
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Jonsson Comprehensive Cancer CenterPfizerAvslutadMelanom (hud)Förenta staterna
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Azienda Ospedaliera Universitaria SeneseOkänd
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Clinica Universidad de Navarra, Universidad de...PfizerAvslutadHepatocellulärt karcinom | Hepatit C-virus kronisk infektionSpanien
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PfizerIndragenHumant immunbristvirus
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AstraZenecaAvslutadRefraktärt melanomFörenta staterna, Spanien, Kanada, Frankrike, Italien, Storbritannien, Argentina, Australien, Tyskland
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AstraZenecaAvslutad
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PfizerInte längre tillgängligAvancerat ooperbart melanom
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University Health Network, TorontoAvslutadMetastaserad bröstcancerKanada
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AstraZenecaAvslutadKarcinom, icke-småcellig lungaFörenta staterna, Kanada, Korea, Republiken av, Storbritannien, Tjeckien