Nivo trial slots ARE still OPEN at Moffitt, in Tampa!

› Forums › General Melanoma Community › Nivo trial slots ARE still OPEN at Moffitt, in Tampa!

  • Post
    • March 8, 2014 at 7:00 pm
    Bubbles
    Participant

      Yes, Virginia…despite the nay-sayers….there really ARE STILL some openings for a Nivolumab trial in Tampa.  Was there Friday and heard it from the horse's mouth and had to sign the amended protocol myself!!!!

      Here's the deal:  An additional arm has been added to my clinical trial…technically named:  A phase 1 trial of a vaccine combining multiple class 1 peptides and montanide ISA 51 VG with escalating doses of anti-PD1 antibody BMS-936558 (now known as Nivolumab) for patients with resected stages IIIC/IV melanoma, NCI protocol P-8316.

      The new arm = Nivolumab and Ipilimumab Administration
      "You will receive your first dose of nivolumab with ipi within 28 days after your screening blood draws.  The dosage of nivo will be 1mg/kg with ipi at 3mg/kg for all patients in this group. Both drugs will be given.  Nivo with ipi will be given as an IV infusion as an outpatient… The next doses of nivo with ipi will be given 3, 6, and 9 weeks after the first. If at week 12 you have not had a return of your tumor, you may also receive additional doses of nivo, this time at 3mg/kg every 2 weeks for up to 2 years….."

      __________________________________________________________________________________

      More info on my blog if interested.  They also seemed to indicate that there were still some slots for the nonresected arm….though I am not positive.  But…don't take my word for it!!!  If you are interested…. CALL!!!  Yours, Celeste

      H. Lee Moffitt Cancer Center & Research Institute
      12902 Magnolia Drive
      Tampa, FL 33612
      Phone: 1-888-MOFFITT (1-888-663-3488)
      Moffitt Cancer Center Switchboard:
      813-745-4673 or 800-456-3434
      Moffitt Cancer Center at International Plaza:
      813-745-1600

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    • Replies
        • March 9, 2014 at 12:46 pm
        Cooper
        Participant

          But be sure to look at inclusion/exclusion before you get your hopes up.  You have to be HLA2 (maybe 1/2 of us are) and have a met they can access among others: 

          • Histologic diagnosis of unresectable Stage III or IV melanoma. All melanomas regardless of primary site of disease will be allowed
          • Measurable unresectable melanoma at least 1 measurable lesion based on Immune-related Response Criteria (irRC)
          • Have failed at least 1 chemotherapy regimen for metastatic disease, and have been treated with up to 2 prior chemotherapy regimens
          • HLA-A*0201 positive as determined by deoxyribonucleic (DNA) allele-specific polymerase chain reaction (PCR) assay; for cohort 5 after amendment 9 and cohort 6, there is no HLA restriction
          • Positive staining of tumor tissue with antibodies to 1 or more of the following: human melanoma black 45 (HMB 45) for gp100, NY-ESO-1, and/or MART-1
          • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
          • Prior chemotherapy or immunotherapy must have been completed at least 4 weeks before study drug administration, and all adverse events have either returned to baseline or stabilized
          • March 9, 2014 at 12:46 pm
          Cooper
          Participant

            But be sure to look at inclusion/exclusion before you get your hopes up.  You have to be HLA2 (maybe 1/2 of us are) and have a met they can access among others: 

            • Histologic diagnosis of unresectable Stage III or IV melanoma. All melanomas regardless of primary site of disease will be allowed
            • Measurable unresectable melanoma at least 1 measurable lesion based on Immune-related Response Criteria (irRC)
            • Have failed at least 1 chemotherapy regimen for metastatic disease, and have been treated with up to 2 prior chemotherapy regimens
            • HLA-A*0201 positive as determined by deoxyribonucleic (DNA) allele-specific polymerase chain reaction (PCR) assay; for cohort 5 after amendment 9 and cohort 6, there is no HLA restriction
            • Positive staining of tumor tissue with antibodies to 1 or more of the following: human melanoma black 45 (HMB 45) for gp100, NY-ESO-1, and/or MART-1
            • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
            • Prior chemotherapy or immunotherapy must have been completed at least 4 weeks before study drug administration, and all adverse events have either returned to baseline or stabilized
            • March 9, 2014 at 12:46 pm
            Cooper
            Participant

              But be sure to look at inclusion/exclusion before you get your hopes up.  You have to be HLA2 (maybe 1/2 of us are) and have a met they can access among others: 

              • Histologic diagnosis of unresectable Stage III or IV melanoma. All melanomas regardless of primary site of disease will be allowed
              • Measurable unresectable melanoma at least 1 measurable lesion based on Immune-related Response Criteria (irRC)
              • Have failed at least 1 chemotherapy regimen for metastatic disease, and have been treated with up to 2 prior chemotherapy regimens
              • HLA-A*0201 positive as determined by deoxyribonucleic (DNA) allele-specific polymerase chain reaction (PCR) assay; for cohort 5 after amendment 9 and cohort 6, there is no HLA restriction
              • Positive staining of tumor tissue with antibodies to 1 or more of the following: human melanoma black 45 (HMB 45) for gp100, NY-ESO-1, and/or MART-1
              • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
              • Prior chemotherapy or immunotherapy must have been completed at least 4 weeks before study drug administration, and all adverse events have either returned to baseline or stabilized
                • March 9, 2014 at 2:30 pm
                Bubbles
                Participant

                  It remains unclear if this arm requires HLA typing as it is newly added and the arm will not be getting vaccines…call and ask if interested!!  Measurable disease is NOT required!! Rather…you must be NED (as is noted in the description) just like the arm I already completed!!!!! Additionally, my arm did NOT have to have failed prior treatment! I had had only surgery and SRS prior to entering trial. Got the newly signed protocol on my desk! If you are interested in the NONresected arm…yes, you must have measureable disease…though I don't think "accessible disease" is absolute.  However, I am not absolutely certain about the exact requirements regarding the tumor, nor am I certain that arm is still recruiting…though it seemed it was when I was there on Friday. If interested…CALL!

                  wishing you all my best -c

                  • March 9, 2014 at 2:30 pm
                  Bubbles
                  Participant

                    It remains unclear if this arm requires HLA typing as it is newly added and the arm will not be getting vaccines…call and ask if interested!!  Measurable disease is NOT required!! Rather…you must be NED (as is noted in the description) just like the arm I already completed!!!!! Additionally, my arm did NOT have to have failed prior treatment! I had had only surgery and SRS prior to entering trial. Got the newly signed protocol on my desk! If you are interested in the NONresected arm…yes, you must have measureable disease…though I don't think "accessible disease" is absolute.  However, I am not absolutely certain about the exact requirements regarding the tumor, nor am I certain that arm is still recruiting…though it seemed it was when I was there on Friday. If interested…CALL!

                    wishing you all my best -c

                    • March 9, 2014 at 2:30 pm
                    Bubbles
                    Participant

                      It remains unclear if this arm requires HLA typing as it is newly added and the arm will not be getting vaccines…call and ask if interested!!  Measurable disease is NOT required!! Rather…you must be NED (as is noted in the description) just like the arm I already completed!!!!! Additionally, my arm did NOT have to have failed prior treatment! I had had only surgery and SRS prior to entering trial. Got the newly signed protocol on my desk! If you are interested in the NONresected arm…yes, you must have measureable disease…though I don't think "accessible disease" is absolute.  However, I am not absolutely certain about the exact requirements regarding the tumor, nor am I certain that arm is still recruiting…though it seemed it was when I was there on Friday. If interested…CALL!

                      wishing you all my best -c

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