Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

• Status: Completed
• Trial end date: 2017-08-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta; Alberta Health Services
• Treatments: Antibodies, Monoclonal; Tremelimumab

Criteria

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)
• Alkaline phosphatase (ALP)
• 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