Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

NCT01034787 | Completed Phase 2 DMC

• 1 other identifier: TBCC 905001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Uveal Melanoma

Keywords

CP-675,206; Immunotherapy; AntiCTLA4; Clinical Trial; Unresectable or Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 6 months after initiation of CP-675,206

  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.

  6 months

Secondary Outcomes (4)

• Objective tumor response

  overall

• Durable response

  6 or more months

• Median survival and overall survival

  overall

• Adverse events and tolerability

  overall

Study Arms (1)

Open Label CP-675,206

EXPERIMENTAL

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.

Drug: CP-675,206

Interventions

CP-675,206 DRUG

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.

Open Label CP-675,206

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (3)

Tom Baker Cancer Centre

Calgary, Alberta, T2N4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• 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.

  PMID: 16258106 BACKGROUND

• 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.

  PMID: 8635073 BACKGROUND

MeSH Terms

Conditions

Uveal Melanoma; Neoplasm Metastasis

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tina Cheng

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 17, 2009
• Study Start: August 17, 2009
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (3)