MelanomaPhase 2NCT01435369
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
A Phase 2 study testing CT-011 in people with Melanoma and Malignant Melanoma, run by Medivation, Inc. at 18 sites in 2 countries.
Trial summary
The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Malignant Melanoma
- What is being tested?
- CT-011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Nov 2011to Aug 2013
- 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
- Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
- Participants age is 18 years or older.
- Stage IV disease that is clearly progressive since last therapy
- ECOG performance status of 0 or 1.
Who cannot join
- Patients with uveal melanoma.
- Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
- Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
- More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
- Women of child bearing potential who are pregnant
- Note: This is only a partial list of eligibility criteria.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States16 sites
Mass General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia Health System / Human Immune Therapy Center
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Chicago
Chicago, Illinois, 60637
Baylor Univesity Medical Center
Dallas, Texas, 75246
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine, Section of Med Onc.
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Ruttenberg Cancer Clinic - The Mount Sinai Hospital
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219-2739
Providence Cancer Center
Portland, Oregon, 97213
Moffitt Cancer Center Cutaneous Oncology Department
Tampa, Florida, 33612
Israel2 sites
Hadassah Medical Center
Jerusalem
Chaim Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.
All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:
Read more
Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).
Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).
Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.
- Conditions
- Melanoma, Malignant Melanoma
- Being tested
- CT-011
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-011Drug
The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months.
| Study group | Role | What they receive |
|---|---|---|
| CT-011 at dose level 1 (1.5 mg/kg). | Active comparator | Not described Receives: Drug: CT-011 |
| CT-011 at dose level 2 (6 mg/kg). | Active comparator | Not described Receives: Drug: CT-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011
Measured: Approximately 28 months
Secondary outcomes (3)
Safety of CT-011
Safety will be assessed for incidence of Adverse Events
Measured: Approximately 28 months
Progression Free Survival by Immune Related Response Criteria
Measured: Approximately 28 months
Overall Survival
Measured: Approximately 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B. Atkins, M.D., Principal investigator, Beth Israel Deaconess Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435369
- Sponsor's protocol ID
- CT-2011-01
- Other IDs
- 2011-004501-24
- Status last verified
- Dec 2015
- First submitted
- 8 Sep 2011
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01435369
- Acronym / sponsor ID
- CT-2011-01
- Conditions
- Melanoma, Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Sep 2011 (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 research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.
All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:
Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).
Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).
Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-011 at dose level 1 (1.5 mg/kg). | Active comparator | Drug: CT-011 |
| CT-011 at dose level 2 (6 mg/kg). | Active comparator | Drug: CT-011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
- Participants age is 18 years or older.
- Stage IV disease that is clearly progressive since last therapy
- ECOG performance status of 0 or 1.
Key exclusion criteria (6 listed)
- Patients with uveal melanoma.
- Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
- Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
- More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
- Women of child bearing potential who are pregnant
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 |
|---|---|---|
| CT-011The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months. | Drug | CT-011 at dose level 1 (1.5 mg/kg)., CT-011 at dose level 2 (6 mg/kg). |
Primary outcome
The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011
Time frame: Approximately 28 months
3 secondary outcomes
Safety of CT-011
Time frame: Approximately 28 months
Progression Free Survival by Immune Related Response Criteria
Time frame: Approximately 28 months
Overall Survival
Time frame: Approximately 28 months
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 21 Jan 2016.
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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.
Michael B. Atkins, M.D. principal investigator
Beth Israel Deaconess Cancer Center
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-011 in people with Melanoma and Malignant Melanoma, run by Medivation, Inc. at 18 sites in 2 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 6 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Israel. 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?
The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011 (time frame: Approximately 28 months). 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 21 Jan 2016.