Bristol-Myers Squibb: U.S. Commitment Studies
U.S. Commitment Studies
Description of
Date Commitment Given FDA Projected Completion Date Study Status Notes
ABATACEPT Continue the open label extensions of 5 studies (IM101-100, IM101-101, IM101-102, IM101-029, IM101-031) to obtain data and perform appropriate safety analyses for 5-years' exposure to Abatacept for 1000-1500 patients. 23-Dec-05 30-Jun-10 Submitted
ABATACEPT Protocol IM101045A, a pharmacoepidemiology study to assess the short term (2 years) and potential long term (4 years) risk of hospitalization due to infection (all hospitalized infections, hospitalized pneumonia, and all opportunistic infections) among patients with RA treated with Abatacept in comparison to other DMARDs within a large cohort of individuals with commercial health insurance. This study will also characterize patients receiving Abatacept and monitor any off-label use. 23-Dec-05 31-Dec-16 Ongoing
ABATACEPT Protocol IM101045B, proposed as an observational prospective pharmacoepidemiology cohort study to assess the short and long-term risk of malignancies and infection in patients with RA treated with Abatacept in comparison to other DMARDs within an existing registry containing patients with rheumatoid arthritis. Follow-up will be for at least 5 years after the last patient is enrolled. 23-Dec-05 31-Dec-16 Ongoing
ABATACEPT Submission of the protocol, interim reports, and final study report for a JIA patient safety registry comprised of at least 500 patients. This protocol should include a plan for more intensive scrutiny for the first 3 years, with annual follow ups (which could be telephonic) assessing for occurrence of malignancies, other autoimmune diseases, and serious infections, for a total of 10 years. Patients turning 18 years of age or older should continue to be followed until they have completed the 10 year follow-up period. Information on these patients may be obtained via annual questionnaire/ telephonic follow-up with attention to key adverse events rather than full clinic visit with examination. Protocol Submission: December 31, 2008; Study Start: June 30, 2009; Interim Report Submissions: June 30, 2014/2019/2024; Final Report Submission: June 30, 2029 7-Apr-08 30-Jun-29 Ongoing
ABATACEPT Conduct a PK/safety study of SC abatacept in polyaricular JIA patients ages 6 to 17 years of age. 29-Jul-11 31-Jan-18 Ongoing
ATAZANAVIR SULPHATE Deferred pediatric study or studies under PREA for the treatment of HIV-1 infection in pediatric patients ages ≥3 months to 18 years to obtain a minimum of 100 patients followed for safety for a minimum of 24 weeks at the recommended dose or any higher doses studied during pediatric development. Final Report Submission: December 15, 2010. 25-Mar-08 31-Mar-15 Ongoing
ATAZANAVIR SULPHATE PMR1: Deferred pediatric study under PREA to evaluate atazanavir oral powder pharmacokinetics, safety, and treatment response to HIV-1 infected pediatric patients 3 months and older who weigh 5 kg to less than 10 kg. 2-Jun-14 2-Jun-15 Ongoing
BELATACEPT PMR 1: Conduct a prospective, observational study utilizing data from the United Network for Organ Sharing (UNOS) on the pattern of belatacept use in US adult kidney-only transplant recipients at transplant and one year post-transplant. Specifically, the study will assess the prevalence of belatacept use and the characteristics of belatacept users, as related to the risk of PTLD, including Epstein-Barr Virus (EBV) and cytomegalovirus (CMV) serostatus. In addition, the study will collect information on adult kidney-only transplant recipients who switch to or from belatacept within one year post-transplant. (Protocol Number IM103074). 15-Jun-11 30-Apr-20 Ongoing
BELATACEPT PMR 2: Conduct a prospective observational study utilizing data from the United Network for Organ Sharing (UNOS) on the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in US adult kidney-only transplant recipients who are treated with belatacept compared to recipients treated with calcineurin inhibitor (CNI)-based regimens. Recipient characteristics will be collected, including EBV and CMV serostatus, location of the PTLD, and outcome (survival or mortality). Incidence rates of PTLD in belatacept-exposed patients will be quantified beginning when 500 belatacept-exposed patients have at least 1 year of follow-up. Relative risks of PTLD for belatacept compared to CNI-based regimens will be estimated after 1,000 person years have been accumulated in transplant recipients initiated on belatacept at transplantation. (Protocol Number IM103075). 15-Jun-11 30-Apr-20 Ongoing
BELATACEPT PMR 3: Conduct a prospective registry of belatacept use in US adult kidney-only transplant recipients to determine the incidence rates of post-transplant lymphoproliferative disorder PTLD, PTLD in the central nervous system (CNS PTLD), and progressive multifocal leukoencephalopathy (PML) in US adult EBV seropositve kidney transplant recipients treated with belatacept in clinical practice. All US adult kidney transplant centers dispensing belatacept will be asked to participate in the study (i.e., if a center does not respond or declines to participate, the reason(s) for nonparticipation will be identified and documented). Recipient characteristics will be collected, including EBV and CMV serostatus, timing of initiation of belatacept in relation to the transplant, location of the PTLD, and outcome (survival or mortality). (Protocol Number IM13076). 15-Jun-11 30-Apr-20 Ongoing
DASATINIB 1699-1 To submit the final report (at least 60 months of follow-up) and data from CA180056 entitled "An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib versus Standard Dose Imatinib in the Treatment of Subjects with Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia." 28-Oct-10 30-Nov-14 Submitted
EFAVIRENZ Conduct a trial to quantify efavirenz QT prolongation in CYP2B6*6 homozygous and heterozygous subjects. 17-Apr-14 29-Feb-16 Ongoing
EFAVIRENZ Perform a label comparison study to determine whether patients and/or caregivers can understand and follow the instructions for use of Sustiva (efavirenz) capsule sprinkles. The protocol for this study should be provided to the Division of Antiviral Products for review and comment prior to study initiation. 2-May-13 31-May-14 Submitted
ENTECAVIR FDA PMC #3: Conduct and submit a final study report for a large simple safety study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients using entecavir compared to standard of care over a period of 5 to 10 years of follow-up. The study should be randomized, stratified according to prior treatment, and of sufficient size to detect a 30% difference in cancer outcomes between the two groups. Monitoring by an independent Data Safety Monitoring Board is recommended. Given the anticipated length of the study, it is recommended that the protocol include plans to assess the adequacy of enrollment and submit interim reports of results at yearly intervals. 29-Mar-05 31-Jul-16 Ongoing
ENTECAVIR PMR 1: Submit integrated analyses for genotypic and phenotypic resistance for studies AI463048, AI463050, AI463085, AI463901, AI463110, and AI463111, and integrated phenotypic resistance analyses for studies AI463028 and AI463189 in SAS format. The virology data should be submitted following the guidance format. 20-Mar-14 31-Dec-15 Ongoing
IPILIMUMAB PMR 3: To develop a validated, sensitive, and accurate assay for the detection of neutralizing antibodies to ipilimumab, including procedures for accurate detection of neutralizing antibodies to ipilimumab in the presence of ipilimumab levels that are expected to be present in the serum or plasma at the time of patient sampling. In the event such an assay can not be developed, evidence of due diligence in attempting to develop the assay will be provided. 25-Mar-11 30-Jun-14 Submitted
IPILIMUMAB PMR 4: To conduct an assessment of anti-drug antibody (ADA) response and neutralizing ADA responses to ipilimumab with a validated assay (required in PMR 2 and 3) capable of sensitively detecting ADA responses in the presence of ipilimumab levels that are expected to be present at the time of patient sampling. The ADA response will be evaluated in at least 300 ipilimumab-treated patients enrolled in the required postmarketing trial (PMR 6) comparing 3 mg/kg versus 10 mg/kg of ipilimumab monotherapy. The final report will include information on the level of ipilimumab in each patient's test sample at each sampling time point. 25-Mar-11 29-Dec-17 Ongoing
IPILIMUMAB PMR 5: During the conduct of the required postmarketing trial comparing 3mg/kg vs. 10mg/kg ipilimumab monotherapy (PMR 6), you will obtain comprehensive baseline DNA sample acquisition (≥ 95% of ITT) and conduct pharmacogenomic association analyses to assess the potential clinical utility of CD86 gene polymorphisms as genetic determinants of immune mediated adverse events. You will provide a protocol that addresses SNP selection, data analyses approaches, and other methodological issues. You will provide a Final Report including electronic datasets. 25-Mar-11 29-Dec-16 Ongoing
IPILIMUMAB PMR 6: Following the assessment of data from Trial CA184024, you will design and conduct a trial to compare the efficacy, with the primary endpoint of overall survival and the safety of ipilimumab at doses of 3mg/kg versus 10mg/kg given as monotherapy every three weeks for four doses in patients with unresectable Stage III or Stage IV melanoma. 25-Mar-11 31-Dec-17 Ongoing
IPILIMUMAB PMC 7: To identify further genetic determinants of immune-mediated adverse events caused by ipilimumab. DNA samples from the required postmarketing study comparing 3 mg/kg vs. 10 mg/kg ipilimumab monotherapy will be used to conduct genome-wide association analyses. The design of these analyses will be reviewed by FDA and a final report with electronic datasets will be provided. 25-Mar-11 31-Dec-18 Ongoing
NIVOLUMAB PMR 1: Conduct and submit the results of a multicenter, randomized trial or trials establishing the superiority of nivolumab over standard therapy in adult patients with unresectable or metastatic melonoma who are refractory to ipilimumab or who have not been previously treated with ipilimumab. 22-Dec-14 31-Dec-16 Pending

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