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Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Rachel Syme, Alberta Health Services.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: December 17, 2009
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services
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.

Condition Intervention Phase
Uveal Melanoma Drug: CP-675,206 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

Resource links provided by NLM:

Further study details as provided by Rachel Syme, Alberta Health Services:

Primary Outcome Measures:
  • Progression-free survival at 6 months after initiation of CP-675,206 [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: January 2010
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label CP-675,206 Drug: 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.l


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034787

Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Alberta Health Services
  More Information

Responsible Party: Rachel Syme, Dr. Tina Cheng, Alberta Health Services
ClinicalTrials.gov Identifier: NCT01034787     History of Changes
Other Study ID Numbers: TBCC 905001
First Submitted: December 15, 2009
First Posted: December 17, 2009
Last Update Posted: January 19, 2012
Last Verified: September 2011

Keywords provided by Rachel Syme, Alberta Health Services:
Clinical Trial
Unresectable or Metastatic

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs