Metastatic MelanomaPhase 1/2NCT02009397
A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
A Phase 1/2 study testing Ipilimumab and GM-CSF in people with Metastatic Melanoma, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Ipilimumab and GM-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients may be entered in the study only if they meet all of the following criteria.
- Male or female patients ≥18 years of age;
- Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
- Life expectancy ≥3 months;
- At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
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- Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
- Absolute neutrophil count (ANC) ≥1.0 x 109/L;
- Platelet count ≥50 x 109/L;
- Hemoglobin ≥8 g/dL;
- Serum creatinine ≤3 x upper limit of normal (ULN)
- Total serum bilirubin ≤2 x ULN;
- Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
- Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
- Pre-menopausal females and females <2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;
- Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
Who cannot join
- Patients will not be entered in the study for any of the following:
- Treatment with Denileukin Diftitox within 42 days prior to the start of Ipilimumab;
- Prior treatment with Ipilimumab;
- Known hypersensitivity to Ipilimumab or any of its components
- Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤1, except for alopecia;
- Steroids within one week prior to initiation of Ipilimumab.
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- Pre-existing autoimmune colitis.
- Patients with an allograft requiring immunosuppression;
- Known positive human immunodeficiency virus (HIV)
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
- Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.
- Conditions
- Metastatic Melanoma
- Being tested
- Ipilimumab, GM-CSF
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
GM-CSFDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab and GM-CSF | Experimental | IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Receives: Drug: Ipilimumab; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immune-related Overall Response Rate (irORR)
Measured: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Jason Chesney, University of Louisville
- Investigators
- Jason Chesney, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009397
- Sponsor's protocol ID
- BCC-MEL-11-02 (Ipi2)
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2013
- Last updated
- 22 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
- ClinicalTrials.gov ID
- NCT02009397
- Acronym / sponsor ID
- BCC-MEL-11-02 (Ipi2)
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Feb 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 22 Nov 2021
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 test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab and GM-CSF | Experimental | Drug: Ipilimumab, Drug: GM-CSFIV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients may be entered in the study only if they meet all of the following criteria.
Key exclusion criteria (11 listed)
- Patients will not be entered in the study for any of the following:
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 |
|---|---|---|
| Ipilimumab | Drug | Ipilimumab and GM-CSF |
| GM-CSF | Drug | Ipilimumab and GM-CSF |
Primary outcome
Change in Immune-related Overall Response Rate (irORR)
Time frame: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jason Chesney, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ipilimumab and GM-CSF in people with Metastatic Melanoma, run by University of Louisville at 1 site 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 16 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 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Immune-related Overall Response Rate (irORR) (time frame: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab). 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 22 Nov 2021.