Metastatic MelanomaPhase 4PROCLIVITY02NCT01856023
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
A Phase 4 study testing High Dose Interleukin-2 and Ipilimumab in people with Metastatic Melanoma, run by Clinigen, Inc. at 12 sites in United States.
Trial summary
Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. 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?
- High Dose Interleukin-2 and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2013to Jul 2015
- Phase
- Phase 4
- 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 or older
- Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
- Meets the requirements for HD IL-2 therapy per Institutional guidelines
- Meets the requirements for ipilimumab therapy per Institutional guidelines
- Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
- At least 4 weeks since last adjuvant therapy or other cancer treatment
- Willing and able to give informed consent and participate in study procedures as described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will also be asked to participate in the 10PLK13 PROCLAIM registry study.
Who cannot join
- Patients with known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) or other infectious hepatitis
- Pregnant, nursing or planning to become pregnant
- Untreated brain metastases. (Brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by MRI at least 6 weeks after definitive therapy are acceptable.)
- Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
- Received prior HD IL-2 therapy.
- Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study.
- Concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Health System
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Moores UCSD Cancer Center
La Jolla, California, 92093
Johns Hopkins Medicine
Lutherville, Maryland, 21093
MSMC Research Program
Miami Beach, Florida, 33140
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
Omaha, Nebraska, 68130
Oncology Specialists, SC
Park Ridge, Illinois, 60068
The University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma
Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy.
Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
Read the detailed description
All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intravenous bolus (IVB) every 8 hours for up to 14 planned doses with an additional cycle 14 days after the first.
Ipilimumab 3mg/kg IV infusion Q3 weeks up to 4 doses4 doses A 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities.
If corticosteroids were required during Ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of HD IL-2.
- Conditions
- Metastatic Melanoma
- Being tested
- High Dose Interleukin-2, Ipilimumab
- Keywords
- melanoma, metastatic, skin cancer, Stage IV, interleukin-2
- Medical subject headings
- Melanoma, Neoplasm Metastasis, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Interleukin-2Drug
Also called Aldesleukin, Proleukin, interleukin
IpilimumabDrug
Also called Yervoy, anti-CTLA4
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Active comparator | Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. Receives: Drug: High Dose Interleukin-2; Drug: Ipilimumab |
| Treatment Arm 2 | Active comparator | Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2. Receives: Drug: High Dose Interleukin-2; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately
evaluable patients who received at least 50% of both research drugs and had their disease re-evaluated after baseline; defined in days for the start of the first treatment to death.
percent of patients alive at 1 year; estimates were assessed using Kaplan-Meier method for the entire subject population for each treatment arm separately.
Measured: start of first treatment to date of death from any cause and patients alive at their last evaluation date were censored up to 1 year.
Secondary outcomes (1)
Progression-free Survival
duration of time (in Days) from start of the first treatment to the time of objective disease progression or death at one year. The immune-related response criteria (irRC) determined based on tumor burden calculated on the WHO method of multiplying the perpendicular dimensions of all lesions are summed to obtain the tumor burden. The total tumor burden + SPD (index lesions) + SPD (new measurable lesions) Based on CT scans and Physical exam at designated timepoints. CR- Disappearance of all known disease; PR>/equal to decrease; SD Neither CR or PD; PD 25%increase; new lesion.
Measured: 5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: slow accrual \& early closure
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- assess the sequenced use of HD IL2 and IPI in metastatic melanoma patients
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinigen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Sapna Patel, MD, Principal investigator, MD AndersonWilliam Sharfman, MD, Principal investigator, Johns Hopkins UniversityJames Lowder, MD, Principal investigator, Prometheus Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856023
- Sponsor's protocol ID
- 12PLK02
- Acronym
- PROCLIVITY02
- Status last verified
- Mar 2023
- First submitted
- 10 May 2013
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01856023
- Acronym / sponsor ID
- PROCLIVITY02 / 12PLK02
- Conditions
- Metastatic Melanoma
- Keywords
- melanoma, metastatic, skin cancer, Stage IV, interleukin-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual \& early closure
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinigen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center, Johns Hopkins University
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy.
Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
Detailed description
All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intravenous bolus (IVB) every 8 hours for up to 14 planned doses with an additional cycle 14 days after the first.
Ipilimumab 3mg/kg IV infusion Q3 weeks up to 4 doses4 doses A 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities.
If corticosteroids were required during Ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of HD IL-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- assess the sequenced use of HD IL2 and IPI in metastatic melanoma patients
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Active comparator | Drug: High Dose Interleukin-2, Drug: IpilimumabPatients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. |
| Treatment Arm 2 | Active comparator | Drug: High Dose Interleukin-2, Drug: IpilimumabPatients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients 18 years or older
- Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
- Meets the requirements for HD IL-2 therapy per Institutional guidelines
- Meets the requirements for ipilimumab therapy per Institutional guidelines
- Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
Key exclusion criteria (7 listed)
- Patients with known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) or other infectious hepatitis
- Pregnant, nursing or planning to become pregnant
- Untreated brain metastases. (Brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by MRI at least 6 weeks after definitive therapy are acceptable.)
- Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
- Received prior HD IL-2 therapy.
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 |
|---|---|---|
| High Dose Interleukin-2Also: Aldesleukin, Proleukin, interleukin | Drug | Treatment Arm 1, Treatment Arm 2 |
| IpilimumabAlso: Yervoy, anti-CTLA4 | Drug | Treatment Arm 1, Treatment Arm 2 |
Primary outcome
Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately
Time frame: start of first treatment to date of death from any cause and patients alive at their last evaluation date were censored up to 1 year.
evaluable patients who received at least 50% of both research drugs and had their disease re-evaluated after baseline; defined in days for the start of the first treatment to death. percent of patients alive at 1 year; estimates were assessed using Kaplan-Meier method for the entire subject population for each treatment arm separately.
1 secondary outcome
Progression-free Survival
Time frame: 5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- 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.
Sapna Patel, MD principal investigator
MD Anderson
William Sharfman, MD principal investigator
Johns Hopkins University
James Lowder, MD principal investigator
Prometheus Labs
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High Dose Interleukin-2 and Ipilimumab in people with Metastatic Melanoma, run by Clinigen, Inc. at 12 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 7 inclusion and 7 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 5 Dec 2023). 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?
Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately (time frame: start of first treatment to date of death from any cause and patients alive at their last evaluation date were censored up to 1 year.). 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 5 Dec 2023.