Malignant MelanomaPhase 2NCT00086489
CP-675,206 In Patients With Advanced Melanoma
A Phase 2 study testing CP-675,206 in people with Malignant Melanoma, run by AstraZeneca at 9 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- CP-675,206
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2003to May 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
- 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
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- 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:
- Absolute neutrophil count >= 1.5 x 10(9)cells/L
- Platelets >= 100 x 10(9)/L
- Hemoglobin >= 10 g/dL
- Aspartate and alanine aminotransferases (AST, ALT) <= 2.5 x ULN (<= 5 x ULN, if documented liver metastases are present)
- Total bilirubin <= 1.5 x ULN
- Creatinine <= 1.5 x ULN
- Patients must have recovered from all prior treatment related toxicities, to baseline status, or a CTC grade of 0 or 1. Post-surgical pain shall not be considered a basis for exclusion.
- Females must either be not of childbearing potential [surgically sterilized, which includes tubal ligation, or at least 2 years postmenopausal; not breastfeeding], or practicing 1 form of approved contraception for at least three months prior to entry into the study with 1 of the following methods: (a) oral contraceptives, (b) intrauterine device, (c) implanted contraceptive (such as Norplant®), (d) injected contraceptives (such as Depo-Provera®), (e) diaphragm, (f) sexual partner must use condom or be surgically sterilized, or (g) sexually inactive. Females of childbearing potential must be instructed to avoid pregnancy during study participation. Negative serum or urine pregnancy test must be documented during screening evaluation.
- Must be willing and able to provide written informed consent.
Who cannot join
- 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.
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- 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.
- Received any prior CTLA4 inhibiting agent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Research Site
Ann Arbor, Michigan, 48109-0008
Research Site
Ann Arbor, Michigan, 48109-0843
Research Site
Chicago, Illinois, 60637-1460
Research Site
Houston, Texas, 77030
Research Site
Los Angeles, California, 90095
Research Site
Nashville, Tennessee, 37232
Research Site
Pittsburgh, Pennsylvania, 15232-1305
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Tampa, Florida, 33612
About this study
Official title: 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.
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
- Conditions
- Malignant Melanoma
- Being tested
- CP-675,206
- Keywords
- metastatic melanoma, multiple dose
- 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
pts treated at 10 mg/kg dose level on a monthly regimen
CP-675,206Drug
pts treated at 15 mg/kg dose level on a quarterly regimen
| Study group | Role | What they receive |
|---|---|---|
| 10 mg/kg | Experimental | pts treated at 10 mg/kg dose level on a monthly regimen Receives: Drug: CP-675,206 |
| 15 mg/kg | Experimental | pts treated at 15 mg/kg dose level on a quarterly regimen Receives: Drug: CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: At every scheduled visit for a maximum of 2 years from first dose of study drug
Tumor response
Measured: Assessed every 2-3 months up to 2 years from first dose of study drug
Secondary outcomes (3)
Monitor for human anti-human antibodies at the end of the study
Measured: Pre-dose (Cycle 1 only) and end of study
Explore genetic influences on safety and or immune response
Measured: Pre-dose, Cycle 1
Assess PK during treatment
Measured: All cycles as pre-specified in protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2004 (estimated)
- Study startAug 2003
- Primary completionMay 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086489
- Sponsor's protocol ID
- A3671002
- Status last verified
- Jun 2012
- First submitted
- 1 Jul 2004
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Comin-Anduix B, Lee Y, Jalil J, Algazi A, de la Rocha P, Camacho LH, Bozon VA, Bulanhagui CA, Seja E, Villanueva A, Straatsma BR, Gualberto A, Economou JS, Glaspy JA, Gomez-Navarro J, Ribas A. Detailed analysis of immunologic effects of the cytotoxic T lymphocyte-associated antigen 4-blocking monoclonal antibody tremelimumab in peripheral blood of patients with melanoma. J Transl Med. 2008 May 1;6:22. doi: 10.1186/1479-5876-6-22.
PubMed 18452610
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00086489
- Acronym / sponsor ID
- A3671002
- Conditions
- Malignant Melanoma
- Keywords
- metastatic melanoma, multiple dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Jul 2004 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg/kg | Experimental | Drug: CP-675,206pts treated at 10 mg/kg dose level on a monthly regimen |
| 15 mg/kg | Experimental | Drug: CP-675,206pts treated at 15 mg/kg dose level on a quarterly regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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-675,206pts treated at 10 mg/kg dose level on a monthly regimen | Drug | 10 mg/kg |
| CP-675,206pts treated at 15 mg/kg dose level on a quarterly regimen | Drug | 15 mg/kg |
Primary outcome
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
3 secondary outcomes
Monitor for human anti-human antibodies at the end of the study
Time frame: Pre-dose (Cycle 1 only) and end of study
Explore genetic influences on safety and or immune response
Time frame: Pre-dose, Cycle 1
Assess PK during treatment
Time frame: All cycles as pre-specified in protocol
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 6 Jun 2012.
- Derived from this study: PubMed 18452610Comin-Anduix B, Lee Y, Jalil J, Algazi A, de la Rocha P, Camacho LH, Bozon VA, Bulanhagui CA, Seja E, Villanueva A, Straatsma BR, Gualberto A, Economou JS, Glaspy JA, Gomez-Navarro J, Ribas A. Detailed analysis of immunologic effects of the cytotoxic T lymphocyte-associated antigen 4-blocking monoclonal antibody tremelimumab in peripheral blood of patients with melanoma. J Transl Med. 2008 May 1;6:22. doi: 10.1186/1479-5876-6-22.
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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.
9 sites in 1 country: 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 Malignant Melanoma, run by AstraZeneca at 9 sites in United States.
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 19 inclusion and 11 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 6 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 9 sites in United States. 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?
Safety (time frame: At every scheduled visit for a maximum of 2 years from first dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00086489, which also lists 1 linked publication.
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 6 Jun 2012.