In-transit Metastases Melanoma Stage IIIB and IIICPhase 2ILP+/-IPINCT02094391

Trial of Ipilimumab After Isolated Limb Perfusion, in Patients With Metastases Melanoma

A Phase 2 study testing Ipilimumab in people with In-transit Metastases Melanoma Stage IIIB and IIIC, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: In-transit Metastases Melanoma Stage IIIB and IIIC
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: 4 participants
Where: 1 siteFrance
Study dates: Mar 2014to Feb 2016
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

Patients with melanoma IT-metastases localized on limb not accessible to a surgical treatment associated or not with regional node metastases (stage IIIB or IIIC: TxN2c or N3) ;
Age above 18 years, no upper limit ;
Evaluable disease according to the RECIST 1.1 criteria ;
ECOG performance status 0-1 ;
Previous specific treatments (chemotherapy, immunotherapy) for the melanoma must be stopped before the inclusion with a wash out period of 3 weeks at least ;
Adequate hematologic, renal and liver function as defined by laboratory values below performed within 4-6 weeks from enrolment :

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White blood count (WBC) greater than or equal to 2.5x109/L
Absolute neutrophil count (ANC) greater than or equal to 1x109/L
Platelet count greater than or equal to 75x109/L
Hemoglobin greater than or equal to 9 g/dL (5.6 mmol/L)
Serum creatinine less or equal to 2.5 times upper limit of laboratory normal (ULN)
ASAT and ALAT < 2 ULN
Calcaemia < 12 mg/dl (2.99 mmol/l)
Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate contraception during the treatment phase of the study and for 1 months afterwards ;
Information of the patient and signature of the informed consent.

Who cannot join

Surgical resectable tumor and metastatic patients (stage IV) ;
Significant cardiovascular disease, e.g congestive heart failure (NYHA Class II, III or IV), severe angina pectoris, cardiac arrhythmias not controlled, myocardial infarction within a 3 months period prior to inclusion, venous thrombosis, occlusive peripheral arterial disease, recent pulmonary embolism ;
Severe lymphoedema of the limb ;
Patients with contraindications to limb hyperthermia ;
Contraindication for the use of vasopressin, anticoagulants, radioactive tracer monitoring ;
Prior hypersensibility to melphalan and/or tasonermin ;

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Prior treatment by Ipilimumab or anti PD1 and PDL1 therapies ;
Severe pulmonary dysfunction ;
Recent history or active peptic ulcer, severe ascites ;
Simultaneous treatment with cardiotoxic substances (e.g anthracyclines) ;
Uncontrolled deep sepsis ;
Pregnancy or breast-feeding ;
Person deprived of his rights or under guardianship ;
Impossibility to submit to the medical follow-up of the trial for geographical, social or psychic reasons ;
History of autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids or patients with history of significant and symptomatic autoimmune disease ;
Chronic steroids > 10 mg/day or chronic immunosuppressive treatment ;
Uncontrolled infectious disease including positive testing for HIV, HBV, HCV ;
No second malignancies in the past 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
Patients in whom the blood supply to the extremity distal to the tumour is suspected to be highly dependent on tumour associated blood vessels. This should be clarified by a Doppler ultrasound.

Trial locations and contacts

1 site in 1 country.

France1 site

Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: A Randomized, Open Label, Multicenter, Comparative Phase II Trial of Ipilimumab After Isolated Limb Perfusion (ILP), in Patients With In-transit Metastases Melanoma Stage IIIB and IIIC

Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result.

Conditions: In-transit Metastases Melanoma Stage IIIB and IIIC
Being tested: Ipilimumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IpilimumabDrug
Ipilimumab is to be administered as an IV infusion with a 1.2μm in-line filter (see current version of Investigator's Brochure), using a volumetric pump, at the 3 mg/kg dose, at the ratio and rate specified in the pharmacy manual, to complete the infusion in 90 minutes with a 100 cc normal saline flush at the end. The total dose needed should be diluted to a total volume of 250 mL in 0.9% sodium chloride injection, USP or 5% Dextrose Injection, USP.. The total dose must be calculated using the most recent subject weight (obtained on the same day of, and prior to, the infusion). If the patient weighs more than 125,0 kg, the Coordinating Investigator needs to be contacted to discuss the total infusion volume, infusion rate and duration. Ipilimumab 3 mg/kg will be administered as a single dose intravenously over 90 minutes every 3 weeks for 4 cycles (Weeks W1, W4, W7, W10). A time interval of +/- 3 days is allowed for Ipilimumab administration.

Study groups in NCT02094391
Study group	Role	What they receive
Ipilimumab	Experimental	Not described Receives: Drug: Ipilimumab
No Ipilimumab	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to progression, local progression or distant progression
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 9 months

Secondary outcomes (1)

Overall Survival
patients who are alive at the time of an analysis will be censored for survival at the time of their last contact
Measured: from randomization to documentation of death due to any cause or the last known alive date up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Feb 2016

First posted21 Mar 2014 (estimated)
Study startMar 2014
Primary completionFeb 2016
Study completionFeb 2016

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 In-transit Metastases Melanoma Stage IIIB and IIICStudies of the same condition, open and under way.
More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02094391
Sponsor's protocol ID: 2013-001610-15
Other IDs: 2013/1974
Acronym: ILP+/-IPI
Status last verified: Jun 2016
First submitted: 13 Mar 2014
Last updated: 9 Jun 2016
Results posted: No
Data monitoring committee: No

Publications

Tulokas SKA, Kohtamaki LM, Makela SP, Juteau S, Alback A, Vikatmaa PJ, Mattila KE, Skytta TK, Koivunen JP, Tyynela-Korhonen K, Hernberg MM. Isolated limb perfusion with melphalan as treatment for regionally advanced melanoma of the limbs: results of 60 patients treated in Finland during 2007-2018. Melanoma Res. 2021 Oct 1;31(5):456-463. doi: 10.1097/CMR.0000000000000755.
PubMed 34132224

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Multicenter, Comparative Phase II Trial of Ipilimumab After Isolated Limb Perfusion (ILP), in Patients With In-transit Metastases Melanoma Stage IIIB and IIIC
ClinicalTrials.gov ID: NCT02094391
Acronym / sponsor ID: ILP+/-IPI / 2013-001610-15
Conditions: In-transit Metastases Melanoma Stage IIIB and IIIC
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
Study start: Mar 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 21 Mar 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ipilimumab	Experimental	Drug: Ipilimumab
No Ipilimumab	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Patients with melanoma IT-metastases localized on limb not accessible to a surgical treatment associated or not with regional node metastases (stage IIIB or IIIC: TxN2c or N3) ;
Age above 18 years, no upper limit ;
Evaluable disease according to the RECIST 1.1 criteria ;
ECOG performance status 0-1 ;
Previous specific treatments (chemotherapy, immunotherapy) for the melanoma must be stopped before the inclusion with a wash out period of 3 weeks at least ;

Key exclusion criteria (19 listed)

Surgical resectable tumor and metastatic patients (stage IV) ;
Significant cardiovascular disease, e.g congestive heart failure (NYHA Class II, III or IV), severe angina pectoris, cardiac arrhythmias not controlled, myocardial infarction within a 3 months period prior to inclusion, venous thrombosis, occlusive peripheral arterial disease, recent pulmonary embolism ;
Severe lymphoedema of the limb ;
Patients with contraindications to limb hyperthermia ;
Contraindication for the use of vasopressin, anticoagulants, radioactive tracer monitoring ;

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
IpilimumabIpilimumab is to be administered as an IV infusion with a 1.2μm in-line filter (see current version of Investigator's Brochure), using a volumetric pump, at the 3 mg/kg dose, at the ratio and rate specified in the pharmacy manual, to complete the infusion in 90 minutes with a 100 cc normal saline flush at the end. The total dose needed should be diluted to a total volume of 250 mL in 0.9% sodium chloride injection, USP or 5% Dextrose Injection, USP.. The total dose must be calculated using the most recent subject weight (obtained on the same day of, and prior to, the infusion). If the patient weighs more than 125,0 kg, the Coordinating Investigator needs to be contacted to discuss the total infusion volume, infusion rate and duration. Ipilimumab 3 mg/kg will be administered as a single dose intravenously over 90 minutes every 3 weeks for 4 cycles (Weeks W1, W4, W7, W10). A time interval of +/- 3 days is allowed for Ipilimumab administration.	Drug	Ipilimumab

Primary outcome

Time to progression, local progression or distant progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 9 months

1 secondary outcome

Overall Survival
Time frame: from randomization to documentation of death due to any cause or the last known alive date up to 24 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 9 Jun 2016.
Derived from this study: PubMed 34132224Tulokas SKA, Kohtamaki LM, Makela SP, Juteau S, Alback A, Vikatmaa PJ, Mattila KE, Skytta TK, Koivunen JP, Tyynela-Korhonen K, Hernberg MM. Isolated limb perfusion with melphalan as treatment for regionally advanced melanoma of the limbs: results of 60 patients treated in Finland during 2007-2018. Melanoma Res. 2021 Oct 1;31(5):456-463. doi: 10.1097/CMR.0000000000000755.

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.

Andrea Cavalcanti, MD study chair

Gustave Roussy, Cancer Campus, Grand Paris

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 In-transit Metastases Melanoma Stage IIIB and IIIC, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 15 inclusion and 19 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 9 Jun 2016. 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 France. 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?

Time to progression, local progression or distant progression (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 9 months). 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 NCT02094391, 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 9 Jun 2016.