Research study anti-pd-1 and KIR vs M3475 Expanded Access

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  • Post
    • May 19, 2014 at 3:24 am
    FayFighter
    Participant

      Short review:

      husband 

      July 2010 dysplastic nevi left calf

      derm exams every 6 months

      July 2013 bump lower left calf and enlarged left groin lymph node

      August 2013 diagnosed stage 3c, groin lymphadenectomy 

      October 2013 – December 2013 ipi Tx 4 cycles total (colitis treated with prednisone and 2 doses remicade)

      Ringing in ears. brain MRI clear. February 2014

      CT clear jan 2014

      April 2014 PET show high SUVs calf , groin and stomach 

      April 2014 Endoscopy with biopsy reveals 3.5 cm lesion in stomach that is melanoma

      Meet with teams at mskcc and penn. Decide on BMS anti-pd1 and KIR trial.  To be begin this weds may 21st

      My Question?

      if husband fails trial, would he be eligible for expanded access MK3475? If you were ever on a Merck 3475 trial that would exclude you but would a BMS trial exclude you?

      Lastly, when do you think the FDA will approved Anti pd 1?

       

      thanks in advance. Anxious to get treatment moving but don't want to make the wrong move. 

       

       

    Viewing 2 reply threads
    • Replies
        • May 19, 2014 at 3:11 pm
        arthurjedi007
        Participant

          BMS pd1 would not exclude you from Merck's EAP.  I read EAP got pushed to October of this year at the earliest. I start the EAP this Wednesday so I'm hoping for the best with it. If I could have made the 28 day washout of being off the taf/mek combo and the doctor would have accepted me with my back damage I would have gone for the BMS pd1/anti-kir or pd1/anti-lag-3. Then like you are thinking have the EAP as a backup plan.

          • May 19, 2014 at 3:11 pm
          arthurjedi007
          Participant

            BMS pd1 would not exclude you from Merck's EAP.  I read EAP got pushed to October of this year at the earliest. I start the EAP this Wednesday so I'm hoping for the best with it. If I could have made the 28 day washout of being off the taf/mek combo and the doctor would have accepted me with my back damage I would have gone for the BMS pd1/anti-kir or pd1/anti-lag-3. Then like you are thinking have the EAP as a backup plan.

              • May 19, 2014 at 4:09 pm
              kylez
              Participant

                It keeps surprising me that there are slots on the PD1/KIR trial, since the number of slots is 16 total for melanoma in the current cohorts. I have wondered if the news of the EAP would draw participants who might otherwise participate in lots of other trials. Maybe accrual now is much slower than I thought it would be.

                ​If I had the choice now of EAP vs. PD1/KIR I'm not sure which I would choose. I chose the first one that could get an IV in my arm.

                • May 19, 2014 at 4:09 pm
                kylez
                Participant

                  It keeps surprising me that there are slots on the PD1/KIR trial, since the number of slots is 16 total for melanoma in the current cohorts. I have wondered if the news of the EAP would draw participants who might otherwise participate in lots of other trials. Maybe accrual now is much slower than I thought it would be.

                  ​If I had the choice now of EAP vs. PD1/KIR I'm not sure which I would choose. I chose the first one that could get an IV in my arm.

                  • May 19, 2014 at 4:54 pm
                  FayFighter
                  Participant

                    Thanks to you both for feedback.  I think they may have added more spots or something to the Anti-PD1/KIR.  The PD1/KIR gets the IV in his arm this Weds.  So we are going for it.

                    Any ideas how they will follow the tumor in his stomach?  It makes me nervous and it seemed ulcerated so I just worry about perforation or something.  He is not losing weight so no issues there.  I forgot to put in original post.  BRAF neg/NRAS pos.  So Mek Inhibitors are backpocket. 

                    Again, Thanks…you all keep me off the ledge.

                    • May 19, 2014 at 4:54 pm
                    FayFighter
                    Participant

                      Thanks to you both for feedback.  I think they may have added more spots or something to the Anti-PD1/KIR.  The PD1/KIR gets the IV in his arm this Weds.  So we are going for it.

                      Any ideas how they will follow the tumor in his stomach?  It makes me nervous and it seemed ulcerated so I just worry about perforation or something.  He is not losing weight so no issues there.  I forgot to put in original post.  BRAF neg/NRAS pos.  So Mek Inhibitors are backpocket. 

                      Again, Thanks…you all keep me off the ledge.

                      • May 20, 2014 at 1:55 am
                      JerryfromFauq
                      Participant

                        HD IL-2 should also be in your backpocket.

                        http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241890/

                        "In the subset of patients for which mutational analysis was available, there was a significant difference in the response rate based on the mutation status: NRAS 47%, BRAF 23%, and WT/WT 12% (p=0.05). Patients with NRAS mutations had non-statistically longer overall survival (5.3 versus 2.4 years, p=0.30) and progression free survival (214 versus 70 days, p=0.13)."

                        • May 20, 2014 at 1:55 am
                        JerryfromFauq
                        Participant

                          HD IL-2 should also be in your backpocket.

                          http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241890/

                          "In the subset of patients for which mutational analysis was available, there was a significant difference in the response rate based on the mutation status: NRAS 47%, BRAF 23%, and WT/WT 12% (p=0.05). Patients with NRAS mutations had non-statistically longer overall survival (5.3 versus 2.4 years, p=0.30) and progression free survival (214 versus 70 days, p=0.13)."

                          • May 20, 2014 at 1:55 am
                          JerryfromFauq
                          Participant

                            HD IL-2 should also be in your backpocket.

                            http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241890/

                            "In the subset of patients for which mutational analysis was available, there was a significant difference in the response rate based on the mutation status: NRAS 47%, BRAF 23%, and WT/WT 12% (p=0.05). Patients with NRAS mutations had non-statistically longer overall survival (5.3 versus 2.4 years, p=0.30) and progression free survival (214 versus 70 days, p=0.13)."

                            • May 19, 2014 at 4:54 pm
                            FayFighter
                            Participant

                              Thanks to you both for feedback.  I think they may have added more spots or something to the Anti-PD1/KIR.  The PD1/KIR gets the IV in his arm this Weds.  So we are going for it.

                              Any ideas how they will follow the tumor in his stomach?  It makes me nervous and it seemed ulcerated so I just worry about perforation or something.  He is not losing weight so no issues there.  I forgot to put in original post.  BRAF neg/NRAS pos.  So Mek Inhibitors are backpocket. 

                              Again, Thanks…you all keep me off the ledge.

                              • May 19, 2014 at 4:09 pm
                              kylez
                              Participant

                                It keeps surprising me that there are slots on the PD1/KIR trial, since the number of slots is 16 total for melanoma in the current cohorts. I have wondered if the news of the EAP would draw participants who might otherwise participate in lots of other trials. Maybe accrual now is much slower than I thought it would be.

                                ​If I had the choice now of EAP vs. PD1/KIR I'm not sure which I would choose. I chose the first one that could get an IV in my arm.

                              • May 19, 2014 at 3:11 pm
                              arthurjedi007
                              Participant

                                BMS pd1 would not exclude you from Merck's EAP.  I read EAP got pushed to October of this year at the earliest. I start the EAP this Wednesday so I'm hoping for the best with it. If I could have made the 28 day washout of being off the taf/mek combo and the doctor would have accepted me with my back damage I would have gone for the BMS pd1/anti-kir or pd1/anti-lag-3. Then like you are thinking have the EAP as a backup plan.

                            Viewing 2 reply threads
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