Metastatic MelanomaPhase 2NCT02009384
Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox
A Phase 2 study testing Ipilimumab in people with Metastatic Melanoma, run by University of Louisville at 1 site in United States.
Trial summary
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 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
- 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;
- Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
- 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 ≥100 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
- Prior treatment with Ipilimumab;
- Known hypersensitivity to Ipilimumab or any of its components;
- Steroids within one week prior to initiation of Ipilimumab.
- 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
Official title: A Phase II Open-Label Study of Ipilimumab Administered to Stage IIIC and Stage IV Melanoma Patients After Regulatory T Cell Depletion With Denileukin Diftitox
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
Read the detailed description
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
- Conditions
- Metastatic Melanoma
- Being tested
- Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
administration of IV ipilimumab for up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab | Experimental | IV ipilimumab Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Using Immune-related Response Criteria (irRC)
no outcomes available, Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed
Measured: baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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 startJan 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: low enrollment r/t requirement of prior treatment with denileukin diftitox
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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, Principal investigator, Brown Cancer Center, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009384
- Sponsor's protocol ID
- BCC-MEL-11-01
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2013
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Study of Ipilimumab Administered to Stage IIIC and Stage IV Melanoma Patients After Regulatory T Cell Depletion With Denileukin Diftitox
- ClinicalTrials.gov ID
- NCT02009384
- Acronym / sponsor ID
- BCC-MEL-11-01
- Conditions
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment r/t requirement of prior treatment with denileukin diftitox
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
Detailed description
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab | Experimental | Drug: IpilimumabIV ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
- Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
Key exclusion criteria (8 listed)
- Prior treatment with Ipilimumab;
- Known hypersensitivity to Ipilimumab or any of its components;
- Steroids within one week prior to initiation of Ipilimumab.
- Pre-existing autoimmune colitis.
- Patients with an allograft requiring immunosuppression;
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 |
|---|---|---|
| Ipilimumabadministration of IV ipilimumab for up to 4 cycles | Drug | Ipilimumab |
Primary outcome
Change From Baseline Using Immune-related Response Criteria (irRC)
Time frame: baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
no outcomes available, Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 principal investigator
Brown Cancer Center, 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 2 study testing Ipilimumab 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 8 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: stopped early, as of the sponsor's last update on 25 Oct 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 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?
Yes. Results are posted in the registry (first posted 25 Oct 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 From Baseline Using Immune-related Response Criteria (irRC) (time frame: baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks). 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 25 Oct 2021.