Refractory MelanomaPhase 2NCT00254579
Study of CP-675,206 in Refractory Melanoma
A Phase 2 study testing CP-675,206 in people with Refractory Melanoma, run by AstraZeneca at 65 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Melanoma
- What is being tested?
- CP-675,206
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 65 sitesin 9 countries
- Study dates
- Dec 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
65 sites in 9 countries.
65 sites in 9 countries
United States36 sites
Research Site
Ann Arbor, Michigan, 48109-0946
Research Site
Aurora, Colorado, 80045
Research Site
Baltimore, Maryland, 21237-3998
Research Site
Bentonville, Arkansas, 72712
Research Site
Bethlehem, Pennsylvania, 18015
Research Site
Boston, Massachusetts, 02215
Research Site
Buffalo, New York, 14263
Research Site
Chapel Hill, North Carolina, 27599-7600
Research Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Columbus, Ohio, 43210
Research Site
Columbus, Ohio, 43210
Research Site
Durham, North Carolina, 27710
Research Site
Fayetteville, Arkansas, 72703
Research Site
Federal Way, Washington, 98003
Research Site
Indianapolis, Indiana, 46202
Research Site
Indianapolis, Indiana, 46237
Research Site
Indianapolis, Indiana, 46260
Research Site
Lakewood, Washington, 98499
Research Site
Little Rock, Arkansas, 72205
Research Site
Los Angeles, California, 90095-6970
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
Madison, Wisconsin, 53792
Research Site
Nashville, Tennessee, 37232-6307
Research Site
Nashville, Tennessee, 37232
Research Site
New York, New York, 10016
Research Site
Ocoee, Florida, 34761
Research Site
Orlando, Florida, 32803
Research Site
Orlando, Florida, 32804
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Salt Lake City, Utah, 84112
Research Site
Scottsdale, Arizona, 85260
Research Site
Seattle, Washington, 98104
Research Site
Seattle, Washington, 98122
Research Site
Stamford, Connecticut, 06902-3628
Research Site
Tacoma, Washington, 98405
United Kingdom7 sites
Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Newcastle upon Tyne, Tyne and Wear, NE4 6BE
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Northwood, Middlesex, HA6 2RN
Research Site
Sutton, Surrey, SM2 5PT
Research Site
Truro, Cornwall, TR1 3LJ
Australia5 sites
Research Site
East Melbourne, Victoria, 3002
Research Site
Nedlands, Western Australia, 6009
Research Site
Waratah, New South Wales, 2298
Research Site
Westmead, New South Wales, 2145
Research Site
Woolloongabba, Queensland, 4102
Germany4 sites
Research Site
Berlin, 10117
Research Site
Frankfurt, 60488
Research Site
Kiel, 24105
Research Site
Tübingen, 72076
Italy4 sites
Research Site
Meldola, FC, 47014
Research Site
Milan, 20132
Research Site
Milan, 20133
Research Site
Milan, 20141
Spain4 sites
Research Site
Barcelona, Barcelona, 08036
Research Site
Madrid, Madrid, 28046
Research Site
Pamplona, Navarre, 31008
Research Site
Zaragoza, Zaragoza, 50009
France3 sites
Research Site
Lille, Cedex, 59037
Research Site
Paris, 75651
Research Site
Villejuif, 94805
Argentina1 site
Research Site
Ciudad de Buenos Aires, Buenos Aires, C1280AEA
About this study
Official 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
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.
- Conditions
- Refractory Melanoma
- Being tested
- CP-675,206
- Keywords
- refractory melanoma, malignant melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-675,206Drug
15 mg/kg Q12W dosing regimen
| Study group | Role | What they receive |
|---|---|---|
| 15 mg/kg CP-675,206 | Experimental | Not described Receives: Drug: CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Tumor response is assessed every 2-3 months until disease progression
Secondary outcomes (4)
Safety
Measured: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Pharmaco Kinetic
Measured: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Survival
Measured: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Health-related QoL
Measured: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory MelanomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254579
- Sponsor's protocol ID
- A3671008
- Status last verified
- Jun 2012
- First submitted
- 14 Nov 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00254579
- Acronym / sponsor ID
- A3671008
- Conditions
- Refractory Melanoma
- Keywords
- refractory melanoma, malignant melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 15 mg/kg CP-675,206 | Experimental | Drug: CP-675,206 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-675,20615 mg/kg Q12W dosing regimen | Drug | 15 mg/kg CP-675,206 |
Primary outcome
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
Time frame: Tumor response is assessed every 2-3 months until disease progression
4 secondary outcomes
Safety
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Pharmaco Kinetic
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Survival
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Health-related QoL
Time frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-675,206 in people with Refractory Melanoma, run by AstraZeneca at 65 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, United Kingdom, Australia, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Tumor response is assessed every 2-3 months until disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.