Estudio Multicéntrico, abierto y en fase II con Ipilimumab ( MDX-010) como extensión de tratamiento en monoterapia o seguimiento para pacientes previamente incluidos en Protocolos/Estudios con Ipilimumab ( MDX-010).Protocolo revisado 08, que incorpora las Cartas Administrativas 01 y 02 y las enmiendas 01,04,05,06,07,08,09, y 10 ( v.10.0 del 10 de septiembre de 2009)A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010) Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) ProtocolsRevised Protocol 08, incorporating Administrative Letter 01, 02, Amendments 01, 04, 05, 06, 07, 08, 09 and 10 (version 10.0, dated 10-Sep-09)
- Conditions
- Stage III, IV metastatic advanced melanomaMelanoma metastásico avanzado estadío III, IV.
- Registration Number
- EUCTR2005-006083-57-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Patients eligible for this study must represent one of the three patient populations described in Section 3.2 of the Protocol and meet the inclusion/exclusion criteria detailed below.
Group C (except Group C Survival Follow-Up Only) patients must meet Inclusion Criteria 1, 2, and 3 and Exclusion Criteria 1 and 2.
Group C Survival Follow-Up Only patients must meet Inclusion Criteria 1, 2, 3 and Exclusion Criterion 2.
1. Willing and able to give written informed consent;
Target population
2. Diagnosis of advanced melanoma;
3. Prior treatment in one of the following studies: CA184008, CA184-022, CA184007, CA184004, MDX010-08 or MDX010-15; and meets criteria for Group A, B or C (see
Section 3.2.)
4. Accessible for treatment and Follow-Up;
5. All patients entering the study as Group A to receive Re-Induction must have their case discussed with a BMS Medical Monitor prior to enrollment in the companion study;
6. Patients who have not experienced IBE related to ipilimumab, or patients who have
experienced a select IBE related to ipilimumab that has completely resolved with
immunosuppressive therapy or controlled with hormone therapy (* see below for
IBEs eligible for consideration, also refer to Section 3.2.2 for definition of select
reversible IBEs):
* List of IBEs eligible for consideration:
a) Reversible autoimmune hepatitis
b) Medically manageable endocrinopathy
c) Reversible dermatological toxicity
7. Have the complete set of baseline (i.e., Screening) images of lesions and radiographic images, including, but not limited to: brain, chest, abdomen pelvis and bone scans (bone scan only as applicable). All images must be of adequate quality;
8. Life expectancy =16 weeks;
9. ECOG performance status of 0 or 1 (Group A patients only, refer to Appendix 3);
10. Required values for initial laboratory tests (Group A patients only):
• WBC = 2000/uL
• ANC = 1000/uL
• Platelets = 50 x 10³/uL
• Hemoglobin = 8 g/dL
• Creatinine = 3.0 x ULN
• AST/ALT = 2.5 x ULN for patients without liver metastasis ; = 5 x ULN for patients with liver metastasis
• Bilirubin = 3.0 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL);
11. No active or chronic infection with HIV, Hepatitis B or Hepatitis C;
Age and Sex
12. Men and women =18 years of age (or, = 16, if allowable per local regulatory authority);
Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last
date of study treatment in such a manner that the risk of pregnancy is minimized.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
For Group A, B, and C patients:
1) Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for ipilimumab;
2) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study.
For Group A and Group B patients:
Sex and Reproductive Status
3) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
4) Women who are pregnant or breastfeeding;
5) Women with a positive pregnancy test on enrollment or prior to study drug administration;
6) Sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control;
Target Disease Exceptions
7) Primary ocular melanoma;
Medical History and Concurrent Diseases
8) Any underlying medical or psychiatric condition or acute infection, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs (such as a condition associated with frequent diarrhea) or efficacy data (such as active lung infection that interferes with response assessments);
8a) 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 (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barré Syndrome) are excluded from this study.
Prohibited Therapies and/or Medications
9) Concomitant therapy with any anti-cancer agent (for up to 30 days prior to 1st dose of ipilimumab in this study and except as defined in Section 6.2.8.5), immunosuppressive agents (for up to 30 days prior to 1st dose of ipilimumab in this study), surgery or radiotherapy (except as defined in Sections 6.2.8.3 and 6.2.8.4) (for up to 30 days prior to 1st dose of ipilimumab in this study); and chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses and for up to 30 days prior to 1st dose of ipilimumab in this study).
10) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 4 weeks prior to or after any dose of ipilimumab);
11) Treatment with other investigational products within the last 4 weeks prior to or during this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method