Brief Title
Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Official Title
Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
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.
Detailed Description
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival at 6 months after initiation of CP-675,206
Secondary Outcome
Objective tumor response
Condition
Uveal Melanoma
Intervention
CP-675,206
Study Arms / Comparison Groups
Open Label CP-675,206
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
11
Start Date
August 17, 2009
Completion Date
August 8, 2017
Primary Completion Date
August 8, 2017
Eligibility 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) /= 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01034787
Organization ID
TBCC 905001
Responsible Party
Principal Investigator
Study Sponsor
AHS Cancer Control Alberta
Study Sponsor
, ,
Verification Date
October 2017