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CP-675,206 In Patients With Advanced Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

CP-675,206 In Patients With Advanced Melanoma

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.

NCT00086489•AstraZeneca

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+9 more criteria

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.
+1 more criteria

Locations (9)

Research Site

Los Angeles, California, United States

Research Site

Tampa, Florida, United States

Research Site

Chicago, Illinois, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

Houston, Texas, United States

Key Dates

Start Date

August 1, 2003

Primary Completion Date

May 1, 2007

Completion Date

May 1, 2009

Last Updated

June 6, 2012

Enrollment

118

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

CP-675,206

DRUG

CP-675,206

DRUG

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CP-675,206 In Patients With Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

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