Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

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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