Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00254579




Registration number
NCT00254579
Ethics application status
Date submitted
14/11/2005
Date registered
16/11/2005
Date last updated
7/06/2012

Titles & IDs
Public title
Study of CP-675,206 in Refractory Melanoma
Scientific title
A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma
Secondary ID [1] 0 0
A3671008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-675,206

Experimental: 15 mg/kg CP-675,206 -


Treatment: Drugs: CP-675,206
15 mg/kg Q12W dosing regimen
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Timepoint [1] 0 0
Tumor response is assessed every 2-3 months until disease progression
Secondary outcome [1] 0 0
Safety
Timepoint [1] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Secondary outcome [2] 0 0
Pharmaco Kinetic
Timepoint [2] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Secondary outcome [3] 0 0
Survival
Timepoint [3] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Secondary outcome [4] 0 0
Health-related QoL
Timepoint [4] 0 0
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

Eligibility
Key inclusion criteria
- Surgically incurable Stage III or IV melanoma

- One prior systemic treatment for metastatic melanoma

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Melanoma of ocular origin

- Received prior vaccine

- Received prior CTLA4-inhibiting agent

- History of, or significant risk for, chronic inflammatory or autoimmune disease

- Potential requirement for systemic corticosteroids

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Waratah
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment hospital [4] 0 0
Research Site - East Melbourne
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
France
State/province [23] 0 0
Cedex
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 13
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Tuebingen
Country [30] 0 0
Italy
State/province [30] 0 0
Meldola, FC
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Spain
State/province [32] 0 0
Navarra
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Zaragoza
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Cornwall
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Middlesex
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Surrey
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Tyne and Wear
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Manchester
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which
is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate
patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct
effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients
with metastatic melanoma in Phase 1 and Phase 2 clinical studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00254579
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00254579