This trial is active, not recruiting.

Condition uveal melanoma
Treatment cp-675,206
Phase phase 2
Sponsor AHS Cancer Control Alberta
Start date January 2010
End date January 2013
Trial size 32 participants
Trial identifier NCT01034787, TBCC 905001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.l

Primary Outcomes

Progression-free survival at 6 months after initiation of CP-675,206
time frame: 6 months

Secondary Outcomes

Objective tumor response
time frame: overall
Durable response, defined as an objective tumor response that last 6 or more months
time frame: 6 or more months
Median survival and overall survival
time frame: overall
Adverse events and tolerability
time frame: overall

Eligibility Criteria

Male or female participants at least 18 years old.

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) /= 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

Additional Information

Official title Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.