None listed
Conditions
Interventions
SUBJECTS WILL BE RANDOMIZED TO RECEIVE ETOPOSIDE AND EITHER CISPLATIN OR CARBOPLATIN (INVESTIGATOR´S CHOICE) PLUS IPILIMUMAB IN A PHASED INDUCTION SCHEDULE, FOLLOWED BY IPILIMUMAB MAINTENANCE, OR ETOP
ULN VS > ULN), CHOICE OF PLATINUM PLANNED TO BE USED DURING INDUCTION (CARBOPLATIN VS CISPLATIN), AND REGION (NORTH AMERICA/WESTERN EUROPE VS OTHER). THESE STRATIFICATION FACTORS WERE CHOSEN BECAUSE O
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT A) WILLING AND ABLE TO PROVIDE INFORMED CONSENT. 2) TARGET POPULATION A) SUBJECTS WITH SCLC DOCUMENTED BY HISTOLOGY OR CYTOLOGY FROM BRUSHING, WASHING OR NEEDLE ASPIRATION OF A DEFINED LESION BUT NOT FROM SPUTUM CYTOLOGY ALONE. B) SUBJECTS MUST PRESENT WITH EXTENSIVE STAGE DISEASE (VALG CLASSIFICATION). C) EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS ≤ 1. D) ACCESSIBLE FOR TREATMENT AND FOLLOW-UP. SUBJECTS ENROLLED IN THIS TRIAL MUST BE TREATED AT THE PARTICIPATING CENTERS. 3) AGE AND REPRODUCTIVE STATUS A) MEN AND WOMEN ≥ 18 YEARS OF AGE. B) WOMEN OFCHILDBEARING POTENTIAL (WOCBP) AND MEN MUST BE USING AN ACCEPTABLE METHOD OF CONTRACEPTION TO AVOID PREGNANCY THROUGHOUT THE STUDY AND FOR UP TO 12 WEEKS AFTER THE LAST DOSE OF STUDY DRUG IN SUCH A MANNER THAT THE RISK OF PREGNANCY IS MINIMIZED. SEE SECTION 3.3.3 FOR THE DEFINITION OF WOCBP. C) 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 INVESTIGATIONAL PRODUCT. D) WOMEN MUST NOT BE BREASTFEEDING.
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE EXCEPTIONS A) CNS METASTASES, UNLESS NON-SYMPTOMATIC (IE, NO NEUROLOGICAL DEFICIT, EPILEPSY OR OTHER SIGNS AND SYMPTOMS TYPICAL OF CNS METASTASES), AND NOT REQUIRING TREATMENT WITH STEROIDS OR ANTICONVULSANT MEDICATIONS. IN ADDITION, IF TREATED WITH RADIATION THERAPY, CNS METASTASES MUST BE STABLE WITH NO EVIDENCE OF PROGRESSION ON SCANS FOR AT LEAST 30 DAYS FROM INITIAL RADIOLOGIC DIAGNOSIS OF CNS METASTASES. B) MALIGNANT PLEURAL EFFUSION THAT IS RECURRENT DESPITE APPROPRIATE SUPPORTIVE CARE. 2) MEDICAL HISTORY AND CONCURRENT DISEASES A) DOCUMENTED HISTORY OF SEVERE AUTOIMMUNE OR IMMUNE MEDIATED SYMPTOMATIC DISEASE THAT REQUIRED PROLONGED (MORE THAN 2 MONTHS) SYSTEMIC IMMUNOSUPPRESSIVE (IE, STEROIDS) TREATMENT SUCH AS: I) ULCERATIVE COLITIS AND CROHN´S DISEASE. II)RHEUMATOID ARTHRITIS, SYSTEMIC PROGRESSIVE SCLEROSIS (SCLERODERMA). III) SYSTEMIC LUPUS ERYTHEMATOSUS. IV) AUTOIMMUNE VASCULITIS (EG, WEGENER´S GRANULOMATOSIS). B) SUBJECTS WITH HISTORY OF MOTOR NEUROPATHY CONSIDERED OF AUTOIMMUNE ORIGIN (EG, GUILLAIN-BARRE SYNDROME). C) SUBJECTS WITH A HISTORY OF TOXIC EPIDERMAL NECROLYSIS (TEN). D) INTERSTITIAL PNEUMONIA OR PULMONARY FIBROSIS. E) PARANEOPLASTIC AUTOIMMUNE SYNDROME•
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Korea North, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kindgdom, United States
Contacts
Public ContactNancy Chacon
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed