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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02662725
Other study ID # 2011_48
Secondary ID 2012-000852-32
Status Completed
Phase Phase 2
First received January 20, 2016
Last updated January 22, 2016
Start date September 2012
Est. completion date December 2015

Study information

Verified date January 2016
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Willing and able to give written informed consent.

2. Men and women = 18 years of age.

3. Patient eligible to single dose Stereotactic Radiotherapy (Radiosurgery) as per the pluridisciplinary committee.

4. Neurologically asymptomatic or pauci-symptomatic patients. Patients with moderated neurological symptoms without systemic corticosteroids treatment can be included.

5. Less than 4 brain metastasis at the MRI. Brain metastasis should measure less than 3 cm in diameter. At least one brain metastasis > 5mm.

6. Maximum one prior systemic therapy for metastatic disease is allowed.

7. Prior treatment with INTERFERON in the adjuvant setting is authorized. Prior treatment with anti-CTLA-4 is NOT authorized.

8. ECOG Performance Status 0 or 1

9. Within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified:

Exclusion Criteria:

1. The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion.

2. Neurological symptoms treated with systemic corticosteroids (whatever the dose of corticoids).

3. 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.

4. Any symptom of concomitant tumour meningitis

5. History of immediate or delayed gadolinium hypersensitivity, or any contraindication to undergo MRI examination (Pacemaker, brain aneurysms clips)

6. 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)

7. 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.

8. 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]).

9. Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain Barré Syndrome) are excluded from this study

10. Previous treatment with a CTLA-4 antagonist agent, including treatment in adjuvant setting.

11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.

12. Lack of availability for clinical follow-up assessments.

13. For female patients: the patient is pregnant or lactating.

14. Women of childbearing potential: refusal or inability to use effective means of contraception

15. Participation in another clinical trial protocol within 30 days prior to enrolment

16. Persons protected by a legal regime (guardianship, trusteeship)

17. Patients in emergency situations

18. Patients kept in detention

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
IPILIMUMAB

Radiation:
Stereotactic radiosurgery


Locations

Country Name City State
France CHU de Bordeaux Bordeaux
France CHU de Caen Caen
France Hôpital Trousseau - CHRU de Tours Chambray-lès-Tours
France CHU - Hôpital d'Estaing Clermont - Ferrand
France Hôpital A. Michallon La Tronche
France CHRU, Hôpital Claude Huriez Lille
France AP-HM Hôpital de la Timone Marseille
France Hôpital Saint Eloi Montpellier
France CHU Nantes - Place Alexis Ricordeau Nantes
France Hôpital Archet 2 Nice
France AP-HP, Hôpital Ambroise Paré Paris
France AP-HP, Hôpital Saint-Louis Paris
France CHU de Bordeaux Pessac
France Centre hospitalier Lyon Sud Pierre-benite
France Centre Régional de Lutte Contre le Cancer Eugène Marquis Rennes
France CHU de Toulouse - Larrey Toulouse
France Hôpitaux de Brabois Vandoeuvre Les Nancy
France Institut Gustave Roussy Villejuif

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival rate until week 96 or death No
Secondary All adverse events = Grade 3 according to CTCAE, Version 4.0 criteria, through study completion, until week 96 Yes
Secondary Overall response rate in brain according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesion until week 96 or death No
Secondary Global overall response rate according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesions until week 96 or death No
Secondary Disease control rate in brain according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesions until week 96 or death No
Secondary Global disease control rate according to immune-related response criteria (ir-RC) and the mWHO criteria of target lesions until week 96 or death No
Secondary Progression free survival until week 96 or death No
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