Good Times

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    • July 28, 2016 at 3:35 pm
    _Paul_
    Participant

      Hi All,

      I took a break from the board for a few months to enjoy my NEDness. It was great. But now I am back because one of my the presumed dead tumors decided otherwise. My onc at the SCCA is talking to me about this trial: https://clinicaltrials.gov/show/NCT02410512. It combines ANTI-PD-L1 with MOXR0916, a humanized agonist anti-OX40 monoclonal antibody. I am trying to find out about the trial, like dosing schedule, toxicities, and the like. Is there anyone here on the trial that can share your experience?

      Thanks – Paul

    Viewing 11 reply threads
    • Replies
        • July 28, 2016 at 6:35 pm
        Mat
        Participant

          Paul, glad to hear that you're doing well.  When I met with Weber last fall, OX-40 seemed to be the big new thing.  Combining with PDL1 sounds even better.  I assume that your keeping ipi-nivo in your back pocket?

            • July 28, 2016 at 7:25 pm
            _Paul_
            Participant

              Hey Mat, yep, still kickin'. I have a bunch of plan B's at the moment: resection (although its not in a great spot, SRS, TIL (my T-cells are on ice) and the combo. I have had a good number of side effects from both IPI and Pembro, so the combo is lower on the list, but I am glad I have it as an option.

              How have you been?

              • July 28, 2016 at 7:25 pm
              _Paul_
              Participant

                Hey Mat, yep, still kickin'. I have a bunch of plan B's at the moment: resection (although its not in a great spot, SRS, TIL (my T-cells are on ice) and the combo. I have had a good number of side effects from both IPI and Pembro, so the combo is lower on the list, but I am glad I have it as an option.

                How have you been?

                • July 28, 2016 at 7:25 pm
                _Paul_
                Participant

                  Hey Mat, yep, still kickin'. I have a bunch of plan B's at the moment: resection (although its not in a great spot, SRS, TIL (my T-cells are on ice) and the combo. I have had a good number of side effects from both IPI and Pembro, so the combo is lower on the list, but I am glad I have it as an option.

                  How have you been?

                • July 28, 2016 at 6:35 pm
                Mat
                Participant

                  Paul, glad to hear that you're doing well.  When I met with Weber last fall, OX-40 seemed to be the big new thing.  Combining with PDL1 sounds even better.  I assume that your keeping ipi-nivo in your back pocket?

                  • July 28, 2016 at 6:35 pm
                  Mat
                  Participant

                    Paul, glad to hear that you're doing well.  When I met with Weber last fall, OX-40 seemed to be the big new thing.  Combining with PDL1 sounds even better.  I assume that your keeping ipi-nivo in your back pocket?

                    • July 28, 2016 at 8:42 pm
                    ed williams
                    Participant

                      Hi Paul, what have the early trials with moxro916 showed as far as side effects? These new go signal (activating) agents seems really interesting, I would be curious about side effect profile. Is the trial set up to get it as monotherapy as an option or is it only going to be offered as a combination with the  pd-L1 inhibitor(Atezolizumab). Best wishes!!!Ed

                        • July 29, 2016 at 1:49 pm
                        _Paul_
                        Participant

                          Hi Ed,

                          The trial offers both of them as a combo, with or without Avastin. The side effect profile of OX-40 appears to be less than PD-1 or PD-L1. This is from the consent form:

                          MOXR0916 is in an early phase of clinical development. As of 12 November 2015, safety data is available for 102 patients treated with MOXR0916 alone (the GO29313 study). Dose levels for these patients ranged from 0.2 mg to 1200 mg. Eighty-seven patients have had at least one side effect while taking MOXR0916.
                          Most of these side effects were mild or moderate and included the following:
                           Feeling tired (fatigue)
                           Rash, hives or itchy skin
                           Diarrhea
                           Infusion-related reactions (allergic reaction)
                           Nausea
                          Severe side effects included:
                           Inflammation of the liver (autoimmune hepatitis)
                           Shortness of breath (dyspnea)
                           Feeling tired (fatigue)
                           Increased blood pressure (hypertension)
                           Decrease in specific white blood cells (lymphopenia)
                          Each of these side effects happened in one patient. There have been no deaths related to MOXR0916.
                           
                          – Paul
                          • July 29, 2016 at 1:49 pm
                          _Paul_
                          Participant

                            Hi Ed,

                            The trial offers both of them as a combo, with or without Avastin. The side effect profile of OX-40 appears to be less than PD-1 or PD-L1. This is from the consent form:

                            MOXR0916 is in an early phase of clinical development. As of 12 November 2015, safety data is available for 102 patients treated with MOXR0916 alone (the GO29313 study). Dose levels for these patients ranged from 0.2 mg to 1200 mg. Eighty-seven patients have had at least one side effect while taking MOXR0916.
                            Most of these side effects were mild or moderate and included the following:
                             Feeling tired (fatigue)
                             Rash, hives or itchy skin
                             Diarrhea
                             Infusion-related reactions (allergic reaction)
                             Nausea
                            Severe side effects included:
                             Inflammation of the liver (autoimmune hepatitis)
                             Shortness of breath (dyspnea)
                             Feeling tired (fatigue)
                             Increased blood pressure (hypertension)
                             Decrease in specific white blood cells (lymphopenia)
                            Each of these side effects happened in one patient. There have been no deaths related to MOXR0916.
                             
                            – Paul
                            • July 29, 2016 at 1:49 pm
                            _Paul_
                            Participant

                              Hi Ed,

                              The trial offers both of them as a combo, with or without Avastin. The side effect profile of OX-40 appears to be less than PD-1 or PD-L1. This is from the consent form:

                              MOXR0916 is in an early phase of clinical development. As of 12 November 2015, safety data is available for 102 patients treated with MOXR0916 alone (the GO29313 study). Dose levels for these patients ranged from 0.2 mg to 1200 mg. Eighty-seven patients have had at least one side effect while taking MOXR0916.
                              Most of these side effects were mild or moderate and included the following:
                               Feeling tired (fatigue)
                               Rash, hives or itchy skin
                               Diarrhea
                               Infusion-related reactions (allergic reaction)
                               Nausea
                              Severe side effects included:
                               Inflammation of the liver (autoimmune hepatitis)
                               Shortness of breath (dyspnea)
                               Feeling tired (fatigue)
                               Increased blood pressure (hypertension)
                               Decrease in specific white blood cells (lymphopenia)
                              Each of these side effects happened in one patient. There have been no deaths related to MOXR0916.
                               
                              – Paul
                            • July 28, 2016 at 8:42 pm
                            ed williams
                            Participant

                              Hi Paul, what have the early trials with moxro916 showed as far as side effects? These new go signal (activating) agents seems really interesting, I would be curious about side effect profile. Is the trial set up to get it as monotherapy as an option or is it only going to be offered as a combination with the  pd-L1 inhibitor(Atezolizumab). Best wishes!!!Ed

                              • July 28, 2016 at 8:42 pm
                              ed williams
                              Participant

                                Hi Paul, what have the early trials with moxro916 showed as far as side effects? These new go signal (activating) agents seems really interesting, I would be curious about side effect profile. Is the trial set up to get it as monotherapy as an option or is it only going to be offered as a combination with the  pd-L1 inhibitor(Atezolizumab). Best wishes!!!Ed

                                • July 29, 2016 at 1:04 am
                                Bubbles
                                Participant

                                  Sorry to hear that, Paul. Here's what I have on OX40: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-other-therapies-after-failing.html

                                  And there's this by Weber that may have some options you can talk with your doc about:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/03/immunology-updatewebinar-for-melanoma.html

                                  Hang in there! Celeste

                                    • July 29, 2016 at 2:31 pm
                                    _Paul_
                                    Participant

                                      Thanks Celeste! As always, you are a treasure trove of information.

                                      – Paul

                                      • July 29, 2016 at 2:31 pm
                                      _Paul_
                                      Participant

                                        Thanks Celeste! As always, you are a treasure trove of information.

                                        – Paul

                                        • July 29, 2016 at 2:31 pm
                                        _Paul_
                                        Participant

                                          Thanks Celeste! As always, you are a treasure trove of information.

                                          – Paul

                                        • July 29, 2016 at 1:04 am
                                        Bubbles
                                        Participant

                                          Sorry to hear that, Paul. Here's what I have on OX40: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-other-therapies-after-failing.html

                                          And there's this by Weber that may have some options you can talk with your doc about:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/03/immunology-updatewebinar-for-melanoma.html

                                          Hang in there! Celeste

                                          • July 29, 2016 at 1:04 am
                                          Bubbles
                                          Participant

                                            Sorry to hear that, Paul. Here's what I have on OX40: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-other-therapies-after-failing.html

                                            And there's this by Weber that may have some options you can talk with your doc about:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/03/immunology-updatewebinar-for-melanoma.html

                                            Hang in there! Celeste

                                            • August 1, 2016 at 6:14 am
                                            adriana cooper
                                            Participant

                                              Paul, Sorry to hear of the setback. Hope it's only minor and it gets it's a** kicked. Adriana still clear and off meds since last scans and when we last met at the conference although she has been having some unexplained back pain. Good luck and keep in touch. Rob and Adriana.

                                                • August 4, 2016 at 3:02 am
                                                _Paul_
                                                Participant

                                                  That's awesome new Rob! Nice to hear from you as well. When was the last she she had a scan?

                                                  • August 4, 2016 at 3:02 am
                                                  _Paul_
                                                  Participant

                                                    That's awesome new Rob! Nice to hear from you as well. When was the last she she had a scan?

                                                    • August 4, 2016 at 3:02 am
                                                    _Paul_
                                                    Participant

                                                      That's awesome new Rob! Nice to hear from you as well. When was the last she she had a scan?

                                                    • August 1, 2016 at 6:14 am
                                                    adriana cooper
                                                    Participant

                                                      Paul, Sorry to hear of the setback. Hope it's only minor and it gets it's a** kicked. Adriana still clear and off meds since last scans and when we last met at the conference although she has been having some unexplained back pain. Good luck and keep in touch. Rob and Adriana.

                                                      • August 1, 2016 at 6:14 am
                                                      adriana cooper
                                                      Participant

                                                        Paul, Sorry to hear of the setback. Hope it's only minor and it gets it's a** kicked. Adriana still clear and off meds since last scans and when we last met at the conference although she has been having some unexplained back pain. Good luck and keep in touch. Rob and Adriana.

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