Table 3

CTLA-4 blockade: Ongoing and recruiting phase II trials (98). *Denotes phase I/II trial.

ClinicalTrials.gov IdentifierTreatment Arm(s)Patient PopulationPrimary Outcome MeasureStatusSponsor
NCT00162123Ipilimumab (3 or 10 mg/kg) vs. Ipilimumab (0.3, 3, or 10 kg/mg) vs. No InterventionExtended-treatment monotherapy or follow-up for melanoma patients previously enrolled in MDX-010SafetyOngoingBristol-Myers Squibb
NCT00378482CP-675,206 (Tremelimumab)Colorectal neoplasms, melanoma, prostatic neoplasms, renal cell carcinoma, neoplasms, patients who have/have had melanoma and other tumorsTo allow access to CP-675,206 for subjects who received CP-675,206 in other trials, Measure safety and efficacyOngoingAstraZeneca
NCT00471887Ticlimumab (CP-675,206)Stage IIIC or Stage IV melanomaChange in percent tumor infiltration by CD8 positive CTLOngoingJonsson Comprehensive Cancer Center
NGT00610857High-dose Interferon Alfa-2b/Anti-CTLA-4 mAbRecurrent inoperable Stage III or Stage IV melanomaImproved response rate with combinationOngoingUniversity of Pittsburgh
NCT00623766Ipilimumab vs. Ipilimumab/CorticosteroidsMelanoma with brain metastasesTumor assessmentOngoingBristol-Myers Squibb
NCT00871481Ipilimumab/Cyclophosphamide/Biopsy/Aldesleukin/IHC/PCR/Immunoenzyme technique/Therapeutic allogeneic CTLMetastatic melanomaNumeric frequency and functional persistence of transferred CTL, Toxicity assessment of study treatment by CTCAE v3.0RecruitingFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
NCT01034787CP-675,206Unresectable or metastatic uveal melanoma6-month PFSOngoingAlberta Health Services
NCT01119508Ipilimumab/TemozolomideMetastatic melanoma6-month PFSOngoingMD Anderson Cancer Center
NCT01134614Ipilimumab vs. Ipilimumab/SargramostimStage III or Stage IV melanoma that cannot be removed by surgeryOSOngoingEastern Cooperative Oncology Group
NCT01216696IpilimumabAdvanced melanoma and spontaneous preexisting immune response to NY-ESO-1Disease control rate (irRC)RecruitingNational Center for Tumor Diseases, Heidelberg
NCT01302496Ipilimumab/TriMix-DCPreviously treated, unresectable Stage III or Stage IV melanomaDisease control rate (irRC)OngoingBart Neyns
NCT01323517Ipilimumab/Melphalan/DactinomycinAdvanced unresectable melanoma of the extremity1-year PFSRecruitingMemorial Sloan-Kettering Cancer Center
NCT01355120IpilimumabOcular melanomaOSRecruitingProf. Dr. med. Dirk Schadendorf
NCT01363206Ipilimumab/GM-CSFUnresectable, metastatic malignant melanomaDisease control rate at 24 weeks (irRC)RecruitingLynn E. Spitler, M.D.
NCT01400451*Ipilimumab/VemurafenibMetastatic melanoma and expression an activated mutant form of the BRAF oncogene (V600E)OSRecruitingBristol-Myers Squibb
NCT01497808*Ipilimumab/Stereotactic body radiation therapyMetastatic melanomaDose-limiting toxicityRecruitingAbramson Cancer Center of the University of Pennsylvania
NCT01565837Ipilimumab/Stereotactic ablative radiosurgeryOligometastatic but unresectable malignant melanomaSafety and tolerabilityRecruitingWolfram Samlowski
NCT01604889*lpilimumab/INCB024360 vs. Ipilimumab/PlaceboUnresectable or metastatic melanomaOSRecruitingIncyte Corporation
NCT01654692Ipilimumab/FotemustineUnresectable locally advanced or metastatic malignant melanomairDCROngoingItalian Network for Tumor Biotherapy
NCT00323882*MDX-010Metastatic hormone-refractory PCSafetyOngoingBristol-Myers Squibb
NCT01194271Ipilimumab/Leuprolide acetate/Radical prostatectomyPCLongitudinal peripheral blood valuesRecruitingMD Anderson Cancer Center
NCT01377389Ipilimumab/Androgen deprivation therapyCastrate-sensitive PCAchieving a PSA ≤ 0.2 ng/ml at7 monthsOngoingMD Anderson Cancer Center
NCT01498978Ipilimumab/Androgen suppression therapyMetastatic hormone-resistant PCFraction of patients who achieve an undetectable PSARecruitingOHSU Knight Cancer Institute
NCT01471197Ipilimumab vs. PermetrexedNon-squamous NSCLCOSRecruitingBristol-Myers Squibb
NCT01331525Ipilimumab/Carboplatin/EtoposideExtensive-stage SCLC1 - year PFSRecruitingUniversity Hospital Southampton NHS Foundation Trust
NCT01524991Ipilimumab/Gemcitabine/CisplatinMetastatic urothelial carcinoma1-year OSRecruitingHoosier Oncology Group
NCT01585987Ipilimumab vs. BSCUnresectable locally advanced/metastatic gastric or gastroesophageal junction cancerirPFSRecruitingBristol-Myers Squibb
NCT01611558IpilimumabRecurrent, platinum-sensitive ovarian cancerAdverse events of grade ≥ 3 during inductionRecruitingBristol-Myers Squibb
NCT01649024TremelimumabMalignant mesotheliomaObjective tumor response by modified RECISTOngoingAzienda Ospedaliera Universitaria Senese
NCT01655888TremelimumabMalignant mesotheliomaObjective responseRecruitingAzienda Ospedaliera Universitaria Senese