MelanomaPhase 2IPI+RTSNCT02662725
Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases
A Phase 2 study testing IPILIMUMAB and Stereotactic radiosurgery in people with Melanoma and Brain Metastasis, run by University Hospital, Lille at 18 sites in France.
Trial summary
This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Brain Metastasis
- What is being tested?
- IPILIMUMAB and Stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 18 sitesFrance
- Study dates
- Sep 2012to Dec 2015
- 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
- Willing and able to give written informed consent.
- Men and women ≥ 18 years of age.
- Patient eligible to single dose Stereotactic Radiotherapy (Radiosurgery) as per the pluridisciplinary committee.
- Neurologically asymptomatic or pauci-symptomatic patients. Patients with moderated neurological symptoms without systemic corticosteroids treatment can be included.
- Less than 4 brain metastasis at the MRI. Brain metastasis should measure less than 3 cm in diameter. At least one brain metastasis > 5mm.
- Maximum one prior systemic therapy for metastatic disease is allowed.
Show all 9Show fewer
- Prior treatment with INTERFERON in the adjuvant setting is authorized. Prior treatment with anti-CTLA-4 is NOT authorized.
- ECOG Performance Status 0 or 1
- Within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified:
Who cannot join
- The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion.
- Neurological symptoms treated with systemic corticosteroids (whatever the dose of corticoids).
- The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk such as but not limited to: Cardiac insufficiency (III or IV as per NYHA classification), Renal insufficiency, ongoing infection.
- Any symptom of concomitant tumour meningitis
- History of immediate or delayed gadolinium hypersensitivity, or any contraindication to undergo MRI examination (Pacemaker, brain aneurysms clips)
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (Subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the study)
Show all 18Show fewer
- Uncontrolled infectious diseases - requires negative tests for clinically suspected HIV, HBV and HCV. If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the Investigator and the Medical Monitor.
- Active autoimmune disease. Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]).
- Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain Barré Syndrome) are excluded from this study
- Previous treatment with a CTLA-4 antagonist agent, including treatment in adjuvant setting.
- The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
- Lack of availability for clinical follow-up assessments.
- For female patients: the patient is pregnant or lactating.
- Women of childbearing potential: refusal or inability to use effective means of contraception
- Participation in another clinical trial protocol within 30 days prior to enrolment
- Persons protected by a legal regime (guardianship, trusteeship)
- Patients in emergency situations
- Patients kept in detention
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU de Bordeaux
Bordeaux
CHU de Caen
Caen
Hôpital Trousseau - CHRU de Tours
Chambray-lès-Tours
CHU - Hôpital d'Estaing
Clermont-Ferrand
Hôpital A. Michallon
La Tronche
CHRU, Hôpital Claude Huriez
Lille
AP-HM Hôpital de la Timone
Marseille
Hôpital Saint Eloi
Montpellier
CHU Nantes - Place Alexis Ricordeau
Nantes
Hôpital Archet 2
Nice
AP-HP, Hôpital Ambroise Paré
Paris
AP-HP, Hôpital Saint-Louis
Paris
CHU de Bordeaux
Pessac
Centre hospitalier Lyon Sud
Pierre-Bénite
Centre Régional de Lutte Contre le Cancer Eugène Marquis
Rennes
CHU de Toulouse - Larrey
Toulouse
Hôpitaux de Brabois
Vandœuvre-lès-Nancy
Institut Gustave Roussy
Villejuif
About this study
Official title: A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases
This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.
- Conditions
- Melanoma, Brain Metastasis
- Being tested
- IPILIMUMAB, Stereotactic radiosurgery
- Keywords
- melanoma, brain metastasis, stereotactic radiosurgery, Ipilimumab, survival, safety, efficacy
- Medical subject headings
- Melanoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPILIMUMABDrug
Stereotactic radiosurgeryRadiation
| Study group | Role | What they receive |
|---|---|---|
| ipilimumab + Stereotactic Radiosurgery | Experimental | ipilimumab combined with a Stereotactic Radiosurgery in Melanoma Patients with Brain Metastases Receives: Drug: IPILIMUMAB; Radiation: Stereotactic radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: until week 96 or death
Secondary outcomes (6)
All adverse events ≥ Grade 3 according to CTCAE, Version 4.0 criteria,
Measured: through study completion, until week 96
Overall response rate in brain
according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesion
Measured: until week 96 or death
Global overall response rate
according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesions
Measured: until week 96 or death
Disease control rate in brain
according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesions
Measured: until week 96 or death
Global disease control rate
according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesions
Measured: until week 96 or death
Progression free survival
Measured: until week 96 or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by University Hospital, LilleThe 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Laurent Mortier, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662725
- Sponsor's protocol ID
- 2011_48
- Other IDs
- 2012-000852-32
- Acronym
- IPI+RTS
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT02662725
- Acronym / sponsor ID
- IPI+RTS / 2011_48
- Conditions
- Melanoma, Brain Metastasis
- Keywords
- melanoma, brain metastasis, stereotactic radiosurgery, Ipilimumab, survival, safety, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jan 2016 (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.
This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ipilimumab + Stereotactic Radiosurgery | Experimental | Drug: IPILIMUMAB, Radiation: Stereotactic radiosurgeryipilimumab combined with a Stereotactic Radiosurgery in Melanoma Patients with Brain Metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to give written informed consent.
- Men and women ≥ 18 years of age.
- Patient eligible to single dose Stereotactic Radiotherapy (Radiosurgery) as per the pluridisciplinary committee.
- Neurologically asymptomatic or pauci-symptomatic patients. Patients with moderated neurological symptoms without systemic corticosteroids treatment can be included.
- Less than 4 brain metastasis at the MRI. Brain metastasis should measure less than 3 cm in diameter. At least one brain metastasis > 5mm.
Key exclusion criteria (18 listed)
- The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion.
- Neurological symptoms treated with systemic corticosteroids (whatever the dose of corticoids).
- The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk such as but not limited to: Cardiac insufficiency (III or IV as per NYHA classification), Renal insufficiency, ongoing infection.
- Any symptom of concomitant tumour meningitis
- History of immediate or delayed gadolinium hypersensitivity, or any contraindication to undergo MRI examination (Pacemaker, brain aneurysms clips)
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 + Stereotactic Radiosurgery |
| Stereotactic radiosurgery | Radiation | ipilimumab + Stereotactic Radiosurgery |
Primary outcome
Overall survival rate
Time frame: until week 96 or death
6 secondary outcomes
All adverse events ≥ Grade 3 according to CTCAE, Version 4.0 criteria,
Time frame: through study completion, until week 96
Overall response rate in brain
Time frame: until week 96 or death
Global overall response rate
Time frame: until week 96 or death
Disease control rate in brain
Time frame: until week 96 or death
Global disease control rate
Time frame: until week 96 or death
Progression free survival
Time frame: until week 96 or death
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 25 Jan 2016.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Laurent Mortier, MD, PhD principal investigator
University Hospital, Lille
18 sites 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 and Stereotactic radiosurgery in people with Melanoma and Brain Metastasis, run by University Hospital, Lille at 18 sites 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 9 inclusion and 18 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 25 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 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?
Overall survival rate (time frame: until week 96 or death). 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 Jan 2016.