Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
|ClinicalTrials.gov Identifier: NCT01034787|
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Drug: CP-675,206||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma|
|Actual Study Start Date :||August 17, 2009|
|Primary Completion Date :||August 8, 2017|
|Study Completion Date :||August 8, 2017|
Experimental: 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.
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.
- Progression-free survival at 6 months after initiation of CP-675,206 [ Time Frame: 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.
- Objective tumor response [ Time Frame: 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.
- Durable response [ Time Frame: 6 or more months ]Durable response is defined as an objective tumor response that last 6 or more months
- Median survival and overall survival [ Time Frame: 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.
- Adverse events and tolerability [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034787
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|