Phase 1 Open Label, Non-Randomized, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Immune Function Effects, And Efficacy Of Multiple Doses Of CP-675,206 In Patients With Advanced Melanoma, And Phase 2, Open Label, Randomized Study To Evaluate the Efficacy, Safety, Tolerability And Pharmacokinetics Of 2 Regimens Of CP-675,206 In Patients With Advanced Melanoma.

AstraZeneca1 site in 1 country118 target enrollmentAugust 2003

ConditionsMalignant Melanoma

InterventionsCP-675,206

DrugsCP-675,206

Overview

Phase: Phase 2
Intervention: CP-675,206
Conditions: Malignant Melanoma
Sponsor: AstraZeneca
Enrollment: 118
Locations: 1
Primary Endpoint: Safety
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma

Registry

clinicaltrials.gov

Start Date

August 2003

End Date

May 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed: Stage III (AJCC 6th edition)xxl unresectable melanoma, with measurable disease (either locally relapsed unresectable, in-transit lesions or unresectable draining nodes) or Stage IV melanoma, including:
•Metastasis to skin, subcutaneous tissues or distant lymph nodes, or
•Metastasis to lungs, or
•Metastasis to all other visceral sites with either LDH \<= ULN (upper limit of normal) or a single site of metastasis
•Note: Patients with melanoma of ocular origin will be considered ineligible
•Documented progressive disease following adjuvant therapy, localized therapy or other therapy for metastatic disease
•Measurable disease defined by at least one target lesion that can be accurately measured and whose size is at least 1.0 cm (by spiral CT) or 2.0 cm (by conventional techniques) in its longest diameter
•ECOG performance status of 0 or 1 Life expectancy of \> 3 months
•Either gender, aged 18 years and above
•Adequate bone marrow, hepatic, and renal functions determined within 2 weeks prior to starting therapy, defined as:

Exclusion Criteria

•Received immunotherapy for cancer within one month prior to the start of screening
•Patients previously treated on this protocol
•History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (e.g. Addison's disease, asthma, celiac disease, multiple sclerosis, Graves Disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc.)
•Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history.
•History of autoimmune colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
•Pregnant or lactating women.
•Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
•Diagnosed or suspected brain metastases. Patients with past history of brain metastases but with no radiologic evidence within 12 weeks prior to enter into the protocol will be eligible.
•Any serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment.
•Coexisting malignancies except for basal or squamous cell carcinoma of the skin.

Arms & Interventions

10 mg/kg

pts treated at 10 mg/kg dose level on a monthly regimen

Intervention: CP-675,206

15 mg/kg

pts treated at 15 mg/kg dose level on a quarterly regimen

Intervention: CP-675,206

Outcomes

Primary Outcomes

Safety

Time Frame: At every scheduled visit for a maximum of 2 years from first dose of study drug

Tumor response

Time Frame: Assessed every 2-3 months up to 2 years from first dose of study drug

Secondary Outcomes

Monitor for human anti-human antibodies at the end of the study(Pre-dose (Cycle 1 only) and end of study)
Explore genetic influences on safety and or immune response(Pre-dose, Cycle 1)
Assess PK during treatment(All cycles as pre-specified in protocol)