#MAGIC TRAIL CROSS TRIAL COLON CANCER PLUS#

ECOG performance status 0-1, or Karnofsky score в‰Ґ 70% (see Appendix A).The following web site may also be used: The PSADT will be computed from the formula: PSADT = (loge2)/k, with k being the estimated slope of the logarithm of PSA over time. To calculate PSADT, there must be at least THREE PSA values, with at least 4 weeks between each measurement. PSADT will be determined from all non-zero PSA values collected preferably, however not limited to, from the 12 months prior to randomization. For the biopsy sub-groups, patients must be willing to undergo pre and on- treatment biopsies.

#MAGIC TRAIL CROSS TRIAL COLON CANCER PLUS#

XRT, cryosurgery, brachytherapy), rising PSA is defined per the Phoenix definition, i.e., 2 consecutive rising values above the PSA nadir plus 2.0 ng/mL. If the subject received other primary therapies (e.g.If the subject's primary therapy was RP (with or without adjuvant or salvage XRT), rising PSA is defined as 2 consecutive rising values above 0.2 ng/mL, each taken в‰Ґ 3 weeks apart, and the last value в‰Ґ 2.0 ng/mL.Salvage XRT or cryotherapy following primary therapy в‰Ґ 6 months prior to randomization is allowed. Previously undergone primary therapy for prostate cancer.Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.Prostate Cancer Adenocarcinoma of the ProstateДrug: Nivolumab Drug: Degarelix Drug: BMS-986253 The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone. The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back. MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-sepcific antigen (PSA). Why Should I Register and Submit Results?.

Magic trail cross trial colon cancer