Extensive stage small cell lung cancer
Conditions
Interventions
Product Name: BMS-734016/MDX-010/Ipilimumab
Pharmaceutical Form:
INN or Proposed INN: Ipilimumab
CAS Number: 477202-00-9
Concentration u
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Willing and able to give written informed consent. • Histologic or cytological diagnosis of small cell lung cancer. • No active or chronic infection with HIV, Hepatitis B, or Hepatitis C. • Performance status ECOG 0 or 1, • Men and women, of or over 18 years of age. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Limited stage small cell lung cancer, appropriate for radical treatment with chemoradiation • Symptomatic CNS metastases (patients with asymptomatic CNS metastases – treated or untreated – may be included in the trial) • Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix. • Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis, Lambert Eaton Myasthenic syndrome). • Any underlying medical, neurological or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea. • Any live vaccine used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab). • Previous chemotherapy for small cell lung cancer, except for patients who have received up to two cycles of Carboplatin and Etoposide at comparible doses to those recommended in the protocol. These patients will be allowed to join the trial at cycle 2 or 3. • A history of prior treatment with ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist. • Concomitant therapy with any of the following: Interleukin 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids. • Women of childbearing potential (WOCBP), as defined as below and who: • Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of their participation in the study and for at least 8 weeks after cessation of study drug, or • Have a positive pregnancy test at baseline, or • Are pregnant or breastfeeding. • Sexually active WOCBP must use an effective method of birth control during the course of the study and for up to 26 weeks after last dose of ipilimumab, in a manner such that risk of failure is minimized. Before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy. All WOCBP must have a negative pregnancy test before first receiving ipilimumab. If the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as: Amenorrhea ? 12 consecutive months without another cause, or for women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level ? 35 mIU/mL. Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial aims to answer whether the addition of Ipilumimab to carboplatin and etoposide chemotherapy for patients with extensive stage small cell lung cancer is able to improve outcome for these patients as assessed by the proportion of patients alive and without progression at 1 year.;Secondary Objective: Secondary objectives include assessment of the toxicity of the combination of ipilimumab together with carboplatin and etoposide chemotherapy and the tumour response to treatment. Disease free survival and overall survival of the trial population will also be assessed as well as quality of life. This will be measured using both standard written quality of life questionnaires and a novel electronic method of data collection using a mobile device carried by the patient for the duration of the trial. Immunological objectives of the trial will be to make a detailed assessment of the patients immune response to ipilimumab and to correlate this with clinical outcome data.;Primary end point(s): 1-year progression free survival. The proportion of patients alive and free from progression one year from consent. Tumour assessments will be by RECIST. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival by RECIST; 1 year overall survival; overall survival; best overall response; duration of response; immune related progression free survival; immune related best overall response; immune related duration of response; toxicity assessment as defined by NCI CTCAE v4.0; quality of life;Timepoint(s) of evaluation of this end point: Progression free survival by RECIST; 1 year overall survival; overall survival; best overall response; duration of response; immune related progression free survival; immune related best overall response; immune related duration of response; toxicity assessment as defined by NCI CTCAE v4.0; quality of life | — |
Countries
United Kingdom
Outcome results
None listed