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Scan results and possible options…

Forums General Melanoma Community Scan results and possible options…

  • Post
    himynameiskevin
    Participant

      Well the most recent CT scan show the tumors in my lungs are still progressing since my last scan on Jan 9th. Some at faster, more alarming rates, and some not so much. Not the news I was hoping for, but, it is what it is, just another little speed bump. I’m in a tricky spot right now. On one hand, as unlikely as it seems, I guess the Yervoy could essentially still kick in any minute, it's been 2 months since my final dose. On the other hand, things are getting worse, and waiting for something that’s unlikely and may not happen may not be in my best interest.

      Well the most recent CT scan show the tumors in my lungs are still progressing since my last scan on Jan 9th. Some at faster, more alarming rates, and some not so much. Not the news I was hoping for, but, it is what it is, just another little speed bump. I’m in a tricky spot right now. On one hand, as unlikely as it seems, I guess the Yervoy could essentially still kick in any minute, it's been 2 months since my final dose. On the other hand, things are getting worse, and waiting for something that’s unlikely and may not happen may not be in my best interest. Some would say wait it out, some would say move on, and they are.

      As suggested by both of my oncologists, before finalizing a decision to wait it out or go with zelboraf, I spent the last 3 days getting every bit of attainable information (disks, written reports, lab notes) of all recent treatments and medical history together and contacted my most recent doctor and team at the National Institute of Health with a brief update of what has been going on, in hopes that maybe they’ll have a trial or an idea we could both benefit from. Maybe they could hit me with the ACT again, as intense as it was, I would love another shot. Or maybe they've got something new to try, something I'd seem like a good candidate for. She agreed to look them over, discuss any options with the team and get back to me. Personally the thought of going back there, just makes my heart warm. At this exact time last year, I was on the mend because of their help, I remember the feeling, and the thought of possibly feeling like that again is… well it makes me smile, a true smile of unabashed happiness and hope. I know the chances of them accepting me for something aren't that great, but with all my history there, and a bit of much needed luck, maybe they will. We'll see. I fed-exed everything yesterday at the fastest rate possible, and hope to hear from them early this week. As always, this waiting in uncertainty is the hardest part, but I’ll be ok.

      On a lighter note, I still feel fine, no pain, trouble breathing, nothing too abnormal from what I can tell. Of course there's some anxiety and nervousness, but during times like these I'm sure it's a pretty normal human reaction and will pass as soon as a plan is in course. 

      Hopefully I'll have a plan and something beneficial to look forward to in the coming days. Until then, thank you all for the ongoing support and help though these stressful times. It means so much.

      I'll talk to you soon.
      -Kevin

    Viewing 23 reply threads
    • Replies
        runnergirl
        Participant

          Kevin—God bless you.  I am amazed at the stories I read here.  I took my last relaxed breath the minute before my husband's derm said Melanoma.

          runnergirl
          Participant

            Kevin—God bless you.  I am amazed at the stories I read here.  I took my last relaxed breath the minute before my husband's derm said Melanoma.

            runnergirl
            Participant

              Kevin—God bless you.  I am amazed at the stories I read here.  I took my last relaxed breath the minute before my husband's derm said Melanoma.

              FormerCaregiver
              Participant

                Kevin, thanks for the latest update. There is always the possibility that you might respond to Yervoy. I don't know if you would be eligible for an anti PD-1 clinical trial, but that could be considered as another option.

                Take care

                Frank from Australia

                  LynnLuc
                  Participant

                    Kevin,

                    Consider this trial perhaps…

                    This is the sister trial of mine…the 4,5,and 6 arm allows for previous use of Anti PD 1

                     

                    Phase I Pilot Study of Peptide Vaccine Comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 Emulsified in Montanide ISA 51 VG and Anti-PD-1 Human Monoclonal Antibody MDX-1106 in Patients With Unresectable Stage III or IV Melanoma

                    Alternate Title
                    Basic Trial Information
                    Objectives
                    Entry Criteria
                    Expected Enrollment
                    Outcomes
                    Outline
                    Trial Contact Information
                    Registry Information

                     

                    Alternate Title

                    Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

                     

                    Basic Trial Information

                     

                     

                    Phase Type Status Age Sponsor Protocol IDs
                    Phase I Biomarker/Laboratory analysis, Treatment Active 16 and over NCI MCC-15400
                    MCC-15400, 7997, NCT01176461

                     

                    Objectives

                     

                    Primary

                    1. To assess the safety and tolerability of multiple class I peptide vaccine comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 emulsified in Montanide ISA 51 VG and anti-PD-1 human monoclonal antibody MDX-1106 (BMS-936558) in HLA-A*0201-positive patients with unresectable stage III or IV malignant melanoma (patients in cohort 6 will not be HLA restricted).

                     

                    Secondary

                    1. To evaluate the immune response at week 12 in patients treated with these regimens compared to the immune response to peptide vaccine alone that was determined in previous studies.
                    2. To assess the host immune response (immunogenicity) to BMS-936558.
                    3. To assess, preliminarily, the efficacy of these regimens in these patients.

                     

                    Entry Criteria

                    Disease Characteristics:

                     

                    • Histologically confirmed melanoma
                      • Unresectable stage III or IV disease
                      • HLA-A*0201 positive by DNA allele-specific PCR assay (not a requirement for cohort 6)

                       

                    • Positive staining of tumor tissue for ≥ 1 of the following: antibody HMB-45 for gp100, NY-ESO-1, and/or MART-1

                       

                    • At least 1 measurable lesion

                       

                    • Must have failed ≥ 1 chemotherapy regimen for metastatic disease

                       

                    • Must have failed prior ipilimumab (cohorts 4, 5, and 6)

                       

                    • Prior treated brain and meningeal metastases allowed provided the following criteria are met:
                      • No evidence of progression by MRI within the past 8 weeks
                      • Off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for ≥ 2 weeks

                       

                    Prior/Concurrent Therapy:

                     

                    • See Disease Characteristics
                    • May have received ≤ 2 prior chemotherapy regimens
                    • At least 4 weeks since prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) and recovered
                    • At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (> 10 mg/day prednisone or equivalent)
                    • At least 4 weeks since prior systemic radiotherapy
                      • At least 2 weeks since prior focal radiotherapy
                      • More than 8 weeks since prior radiopharmaceuticals (strontium, samarium)
                    • At least 6 weeks since prior nitrosourea
                    • At least 2 weeks since prior surgery that required general anesthesia
                      • At least 72 hours since prior surgery requiring local and/or epidural anesthesia
                    • No prior anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways)
                    • No concurrent participation in another clinical study involving treatment with medications, radiotherapy, or surgery or prior participation in this study
                    • No concurrent use of any of the following:
                      • Other anticancer agents
                      • Immunosuppressive agents
                      • Immunosuppressive doses of systemic or topical steroids whose absorption is expected to result in systemically immunosuppressive steroid levels
                      • Non-oncologic vaccines (during and ≥ 4 weeks after study treatment)
                    • Patients in the fourth cohort must meet the following criteria:
                      • Ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of anti-PD-1 human monoclonal antibody MDX-1106 (MDX-1106)
                      • Ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of MDX-1106
                      • All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
                      • Patients must be off steroids for at least 3 weeks
                      • No patients who required infliximab or other immune suppressants including mycophenolic acid
                    • Patients in the fifth and sixth cohort must meet the following criteria:
                      • Ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of MDX-1106
                      • All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
                      • Patients must be off steroids for at least 3 weeks
                      • No patients who required infliximab or other immune suppressants including mycophenolic acid

                     

                     

                    Patient Characteristics:

                     

                    • ECOG performance status 0-1
                    • Life expectancy ≥ 3 months
                    • WBC ≥ 2,000/μL
                    • ANC ≥ 1,500/μL
                    • Platelet count ≥ 100,000/μL
                    • Hemoglobin ≥ 9.0 g/dL
                    • Serum creatinine ≤ 2 mg/dL
                    • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for hepatic metastasis)
                    • Bilirubin ≤ 2 times ULN (< 3 times ULN for patients with Gilbert syndrome)
                    • Fertile patients must agree to use effective contraception for ≥ 28 days before, during, and for ≥ 70 days (180 days for males) after completion of treatment period
                    • Negative pregnancy test
                    • Not pregnant or nursing
                    • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
                    • No history of severe hypersensitivity reactions to other monoclonal antibodies
                    • No systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component
                    • No active malignancy within the past 2 years except for curatively treated local cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
                    • No prior or active autoimmune disease, or history of syndrome requiring systemic steroids or immunosuppressive medications
                      • Patients with vitiligo or resolved childhood asthma and/or atopy allowed
                    • No known HIV positivity or AIDS
                    • Not positive for hepatitis B virus surface antigen or hepatitis C virus RNA indicating active or chronic infection
                    • No underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of any of the study drugs hazardous to the patient, or obscure the interpretation of toxicity determination or adverse events
                    • No concurrent medical condition requiring the use of immunosuppressive doses of systemic or absorbable topical corticosteroids

                     

                    Expected Enrollment

                    85

                    Outcomes

                    Primary Outcome(s)

                    Best overall response (complete or partial response, stable disease, or progressive disease)
                    Adverse events

                    Secondary Outcome(s)

                    Time to response
                    Duration of response

                     

                    Outline

                     

                    This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.

                     

                    Patients receive peptide vaccines* comprising gp 100 (210M), MART-1 (27L), gp100 (288V), and NY-ESO-1(165V) emulsified by Montanide ISA 51 VG subcutaneously and anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes once a week on weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for 2 courses. Patients with responsive or stable disease continue to receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

                     

                    [Note: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.]

                    Blood samples are collected for pharmacokinetic and immunologic analysis.

                    After completion of study therapy, patients are followed up periodically for 2 years.

                    Trial Contact Information

                    Trial Lead Organizations

                    H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

                     

                     

                    Jeffrey Weber, MD, PhD, Principal investigator
                    Ph: 813-747-2691; 888-663-3488

                     

                    Trial Sites

                     

                     

                    U.S.A.
                    Florida
                      Tampa
                           
                     
                     
                     
                      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
                     
                      Clinical Trials Office – H. Lee Moffitt Cancer Center and Reseach Institute
                    Ph: 800-456-7121
                       
                      Email: [email protected]
                     

                    See All Trial Sites

                     

                     

                     

                    Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

                    LynnLuc
                    Participant

                      Kevin,

                      Consider this trial perhaps…

                      This is the sister trial of mine…the 4,5,and 6 arm allows for previous use of Anti PD 1

                       

                      Phase I Pilot Study of Peptide Vaccine Comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 Emulsified in Montanide ISA 51 VG and Anti-PD-1 Human Monoclonal Antibody MDX-1106 in Patients With Unresectable Stage III or IV Melanoma

                      Alternate Title
                      Basic Trial Information
                      Objectives
                      Entry Criteria
                      Expected Enrollment
                      Outcomes
                      Outline
                      Trial Contact Information
                      Registry Information

                       

                      Alternate Title

                      Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

                       

                      Basic Trial Information

                       

                       

                      Phase Type Status Age Sponsor Protocol IDs
                      Phase I Biomarker/Laboratory analysis, Treatment Active 16 and over NCI MCC-15400
                      MCC-15400, 7997, NCT01176461

                       

                      Objectives

                       

                      Primary

                      1. To assess the safety and tolerability of multiple class I peptide vaccine comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 emulsified in Montanide ISA 51 VG and anti-PD-1 human monoclonal antibody MDX-1106 (BMS-936558) in HLA-A*0201-positive patients with unresectable stage III or IV malignant melanoma (patients in cohort 6 will not be HLA restricted).

                       

                      Secondary

                      1. To evaluate the immune response at week 12 in patients treated with these regimens compared to the immune response to peptide vaccine alone that was determined in previous studies.
                      2. To assess the host immune response (immunogenicity) to BMS-936558.
                      3. To assess, preliminarily, the efficacy of these regimens in these patients.

                       

                      Entry Criteria

                      Disease Characteristics:

                       

                      • Histologically confirmed melanoma
                        • Unresectable stage III or IV disease
                        • HLA-A*0201 positive by DNA allele-specific PCR assay (not a requirement for cohort 6)

                         

                      • Positive staining of tumor tissue for ≥ 1 of the following: antibody HMB-45 for gp100, NY-ESO-1, and/or MART-1

                         

                      • At least 1 measurable lesion

                         

                      • Must have failed ≥ 1 chemotherapy regimen for metastatic disease

                         

                      • Must have failed prior ipilimumab (cohorts 4, 5, and 6)

                         

                      • Prior treated brain and meningeal metastases allowed provided the following criteria are met:
                        • No evidence of progression by MRI within the past 8 weeks
                        • Off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for ≥ 2 weeks

                         

                      Prior/Concurrent Therapy:

                       

                      • See Disease Characteristics
                      • May have received ≤ 2 prior chemotherapy regimens
                      • At least 4 weeks since prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) and recovered
                      • At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (> 10 mg/day prednisone or equivalent)
                      • At least 4 weeks since prior systemic radiotherapy
                        • At least 2 weeks since prior focal radiotherapy
                        • More than 8 weeks since prior radiopharmaceuticals (strontium, samarium)
                      • At least 6 weeks since prior nitrosourea
                      • At least 2 weeks since prior surgery that required general anesthesia
                        • At least 72 hours since prior surgery requiring local and/or epidural anesthesia
                      • No prior anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways)
                      • No concurrent participation in another clinical study involving treatment with medications, radiotherapy, or surgery or prior participation in this study
                      • No concurrent use of any of the following:
                        • Other anticancer agents
                        • Immunosuppressive agents
                        • Immunosuppressive doses of systemic or topical steroids whose absorption is expected to result in systemically immunosuppressive steroid levels
                        • Non-oncologic vaccines (during and ≥ 4 weeks after study treatment)
                      • Patients in the fourth cohort must meet the following criteria:
                        • Ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of anti-PD-1 human monoclonal antibody MDX-1106 (MDX-1106)
                        • Ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of MDX-1106
                        • All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
                        • Patients must be off steroids for at least 3 weeks
                        • No patients who required infliximab or other immune suppressants including mycophenolic acid
                      • Patients in the fifth and sixth cohort must meet the following criteria:
                        • Ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of MDX-1106
                        • All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
                        • Patients must be off steroids for at least 3 weeks
                        • No patients who required infliximab or other immune suppressants including mycophenolic acid

                       

                       

                      Patient Characteristics:

                       

                      • ECOG performance status 0-1
                      • Life expectancy ≥ 3 months
                      • WBC ≥ 2,000/μL
                      • ANC ≥ 1,500/μL
                      • Platelet count ≥ 100,000/μL
                      • Hemoglobin ≥ 9.0 g/dL
                      • Serum creatinine ≤ 2 mg/dL
                      • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for hepatic metastasis)
                      • Bilirubin ≤ 2 times ULN (< 3 times ULN for patients with Gilbert syndrome)
                      • Fertile patients must agree to use effective contraception for ≥ 28 days before, during, and for ≥ 70 days (180 days for males) after completion of treatment period
                      • Negative pregnancy test
                      • Not pregnant or nursing
                      • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
                      • No history of severe hypersensitivity reactions to other monoclonal antibodies
                      • No systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component
                      • No active malignancy within the past 2 years except for curatively treated local cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
                      • No prior or active autoimmune disease, or history of syndrome requiring systemic steroids or immunosuppressive medications
                        • Patients with vitiligo or resolved childhood asthma and/or atopy allowed
                      • No known HIV positivity or AIDS
                      • Not positive for hepatitis B virus surface antigen or hepatitis C virus RNA indicating active or chronic infection
                      • No underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of any of the study drugs hazardous to the patient, or obscure the interpretation of toxicity determination or adverse events
                      • No concurrent medical condition requiring the use of immunosuppressive doses of systemic or absorbable topical corticosteroids

                       

                      Expected Enrollment

                      85

                      Outcomes

                      Primary Outcome(s)

                      Best overall response (complete or partial response, stable disease, or progressive disease)
                      Adverse events

                      Secondary Outcome(s)

                      Time to response
                      Duration of response

                       

                      Outline

                       

                      This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.

                       

                      Patients receive peptide vaccines* comprising gp 100 (210M), MART-1 (27L), gp100 (288V), and NY-ESO-1(165V) emulsified by Montanide ISA 51 VG subcutaneously and anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes once a week on weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for 2 courses. Patients with responsive or stable disease continue to receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

                       

                      [Note: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.]

                      Blood samples are collected for pharmacokinetic and immunologic analysis.

                      After completion of study therapy, patients are followed up periodically for 2 years.

                      Trial Contact Information

                      Trial Lead Organizations

                      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

                       

                       

                      Jeffrey Weber, MD, PhD, Principal investigator
                      Ph: 813-747-2691; 888-663-3488

                       

                      Trial Sites

                       

                       

                      U.S.A.
                      Florida
                        Tampa
                             
                       
                       
                       
                        H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
                       
                        Clinical Trials Office – H. Lee Moffitt Cancer Center and Reseach Institute
                      Ph: 800-456-7121
                         
                        Email: [email protected]
                       

                      See All Trial Sites

                       

                       

                       

                      Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

                      LynnLuc
                      Participant

                        Kevin,

                        Consider this trial perhaps…

                        This is the sister trial of mine…the 4,5,and 6 arm allows for previous use of Anti PD 1

                         

                        Phase I Pilot Study of Peptide Vaccine Comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 Emulsified in Montanide ISA 51 VG and Anti-PD-1 Human Monoclonal Antibody MDX-1106 in Patients With Unresectable Stage III or IV Melanoma

                        Alternate Title
                        Basic Trial Information
                        Objectives
                        Entry Criteria
                        Expected Enrollment
                        Outcomes
                        Outline
                        Trial Contact Information
                        Registry Information

                         

                        Alternate Title

                        Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

                         

                        Basic Trial Information

                         

                         

                        Phase Type Status Age Sponsor Protocol IDs
                        Phase I Biomarker/Laboratory analysis, Treatment Active 16 and over NCI MCC-15400
                        MCC-15400, 7997, NCT01176461

                         

                        Objectives

                         

                        Primary

                        1. To assess the safety and tolerability of multiple class I peptide vaccine comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 emulsified in Montanide ISA 51 VG and anti-PD-1 human monoclonal antibody MDX-1106 (BMS-936558) in HLA-A*0201-positive patients with unresectable stage III or IV malignant melanoma (patients in cohort 6 will not be HLA restricted).

                         

                        Secondary

                        1. To evaluate the immune response at week 12 in patients treated with these regimens compared to the immune response to peptide vaccine alone that was determined in previous studies.
                        2. To assess the host immune response (immunogenicity) to BMS-936558.
                        3. To assess, preliminarily, the efficacy of these regimens in these patients.

                         

                        Entry Criteria

                        Disease Characteristics:

                         

                        • Histologically confirmed melanoma
                          • Unresectable stage III or IV disease
                          • HLA-A*0201 positive by DNA allele-specific PCR assay (not a requirement for cohort 6)

                           

                        • Positive staining of tumor tissue for ≥ 1 of the following: antibody HMB-45 for gp100, NY-ESO-1, and/or MART-1

                           

                        • At least 1 measurable lesion

                           

                        • Must have failed ≥ 1 chemotherapy regimen for metastatic disease

                           

                        • Must have failed prior ipilimumab (cohorts 4, 5, and 6)

                           

                        • Prior treated brain and meningeal metastases allowed provided the following criteria are met:
                          • No evidence of progression by MRI within the past 8 weeks
                          • Off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for ≥ 2 weeks

                           

                        Prior/Concurrent Therapy:

                         

                        • See Disease Characteristics
                        • May have received ≤ 2 prior chemotherapy regimens
                        • At least 4 weeks since prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) and recovered
                        • At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (> 10 mg/day prednisone or equivalent)
                        • At least 4 weeks since prior systemic radiotherapy
                          • At least 2 weeks since prior focal radiotherapy
                          • More than 8 weeks since prior radiopharmaceuticals (strontium, samarium)
                        • At least 6 weeks since prior nitrosourea
                        • At least 2 weeks since prior surgery that required general anesthesia
                          • At least 72 hours since prior surgery requiring local and/or epidural anesthesia
                        • No prior anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways)
                        • No concurrent participation in another clinical study involving treatment with medications, radiotherapy, or surgery or prior participation in this study
                        • No concurrent use of any of the following:
                          • Other anticancer agents
                          • Immunosuppressive agents
                          • Immunosuppressive doses of systemic or topical steroids whose absorption is expected to result in systemically immunosuppressive steroid levels
                          • Non-oncologic vaccines (during and ≥ 4 weeks after study treatment)
                        • Patients in the fourth cohort must meet the following criteria:
                          • Ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of anti-PD-1 human monoclonal antibody MDX-1106 (MDX-1106)
                          • Ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of MDX-1106
                          • All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
                          • Patients must be off steroids for at least 3 weeks
                          • No patients who required infliximab or other immune suppressants including mycophenolic acid
                        • Patients in the fifth and sixth cohort must meet the following criteria:
                          • Ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of MDX-1106
                          • All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
                          • Patients must be off steroids for at least 3 weeks
                          • No patients who required infliximab or other immune suppressants including mycophenolic acid

                         

                         

                        Patient Characteristics:

                         

                        • ECOG performance status 0-1
                        • Life expectancy ≥ 3 months
                        • WBC ≥ 2,000/μL
                        • ANC ≥ 1,500/μL
                        • Platelet count ≥ 100,000/μL
                        • Hemoglobin ≥ 9.0 g/dL
                        • Serum creatinine ≤ 2 mg/dL
                        • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for hepatic metastasis)
                        • Bilirubin ≤ 2 times ULN (< 3 times ULN for patients with Gilbert syndrome)
                        • Fertile patients must agree to use effective contraception for ≥ 28 days before, during, and for ≥ 70 days (180 days for males) after completion of treatment period
                        • Negative pregnancy test
                        • Not pregnant or nursing
                        • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
                        • No history of severe hypersensitivity reactions to other monoclonal antibodies
                        • No systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component
                        • No active malignancy within the past 2 years except for curatively treated local cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
                        • No prior or active autoimmune disease, or history of syndrome requiring systemic steroids or immunosuppressive medications
                          • Patients with vitiligo or resolved childhood asthma and/or atopy allowed
                        • No known HIV positivity or AIDS
                        • Not positive for hepatitis B virus surface antigen or hepatitis C virus RNA indicating active or chronic infection
                        • No underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of any of the study drugs hazardous to the patient, or obscure the interpretation of toxicity determination or adverse events
                        • No concurrent medical condition requiring the use of immunosuppressive doses of systemic or absorbable topical corticosteroids

                         

                        Expected Enrollment

                        85

                        Outcomes

                        Primary Outcome(s)

                        Best overall response (complete or partial response, stable disease, or progressive disease)
                        Adverse events

                        Secondary Outcome(s)

                        Time to response
                        Duration of response

                         

                        Outline

                         

                        This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.

                         

                        Patients receive peptide vaccines* comprising gp 100 (210M), MART-1 (27L), gp100 (288V), and NY-ESO-1(165V) emulsified by Montanide ISA 51 VG subcutaneously and anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes once a week on weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for 2 courses. Patients with responsive or stable disease continue to receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

                         

                        [Note: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.]

                        Blood samples are collected for pharmacokinetic and immunologic analysis.

                        After completion of study therapy, patients are followed up periodically for 2 years.

                        Trial Contact Information

                        Trial Lead Organizations

                        H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

                         

                         

                        Jeffrey Weber, MD, PhD, Principal investigator
                        Ph: 813-747-2691; 888-663-3488

                         

                        Trial Sites

                         

                         

                        U.S.A.
                        Florida
                          Tampa
                               
                         
                         
                         
                          H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
                         
                          Clinical Trials Office – H. Lee Moffitt Cancer Center and Reseach Institute
                        Ph: 800-456-7121
                           
                          Email: [email protected]
                         

                        See All Trial Sites

                         

                         

                         

                        Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

                        LynnLuc
                        Participant

                          Correction  Previous USE of IPI!! I need SLEEP!! Long Day at Disney World today!

                          LynnLuc
                          Participant

                            Correction  Previous USE of IPI!! I need SLEEP!! Long Day at Disney World today!

                            LynnLuc
                            Participant

                              Correction  Previous USE of IPI!! I need SLEEP!! Long Day at Disney World today!

                            FormerCaregiver
                            Participant

                              Kevin, thanks for the latest update. There is always the possibility that you might respond to Yervoy. I don't know if you would be eligible for an anti PD-1 clinical trial, but that could be considered as another option.

                              Take care

                              Frank from Australia

                              FormerCaregiver
                              Participant

                                Kevin, thanks for the latest update. There is always the possibility that you might respond to Yervoy. I don't know if you would be eligible for an anti PD-1 clinical trial, but that could be considered as another option.

                                Take care

                                Frank from Australia

                                davidfromsingapore
                                Participant

                                  Hi Kevin

                                  I feel your pain.  I had a melanoma recurrence – 3 mets to the brain – in Oct. 2011.  My doc, a very well respected melanoma doc at Mayo, put me on Zelboraf.  So far so good,  The only problems is that it is not a cure.  Usually only lasts 6 months or so, so you need to have a plan b going in to it.  

                                   

                                  good luck, david

                                  davidfromsingapore
                                  Participant

                                    Hi Kevin

                                    I feel your pain.  I had a melanoma recurrence – 3 mets to the brain – in Oct. 2011.  My doc, a very well respected melanoma doc at Mayo, put me on Zelboraf.  So far so good,  The only problems is that it is not a cure.  Usually only lasts 6 months or so, so you need to have a plan b going in to it.  

                                     

                                    good luck, david

                                    davidfromsingapore
                                    Participant

                                      Hi Kevin

                                      I feel your pain.  I had a melanoma recurrence – 3 mets to the brain – in Oct. 2011.  My doc, a very well respected melanoma doc at Mayo, put me on Zelboraf.  So far so good,  The only problems is that it is not a cure.  Usually only lasts 6 months or so, so you need to have a plan b going in to it.  

                                       

                                      good luck, david

                                      Dave G
                                      Participant

                                        Kevin,

                                        I also tried the Yervoy route with no luck. Then IL2 – again no luck. I'm still hoping that maybe one or both of these treatments kick in late and do some good but I can't wait on that. Going to try another trial in a week and I understand there are others but I need get off this steroid first. The way I see it why not keep getting up to bat and give it a go – what else is there to do anyway?

                                        Keep at it and good luck,

                                        Dave G

                                        Dave G
                                        Participant

                                          Kevin,

                                          I also tried the Yervoy route with no luck. Then IL2 – again no luck. I'm still hoping that maybe one or both of these treatments kick in late and do some good but I can't wait on that. Going to try another trial in a week and I understand there are others but I need get off this steroid first. The way I see it why not keep getting up to bat and give it a go – what else is there to do anyway?

                                          Keep at it and good luck,

                                          Dave G

                                          Dave G
                                          Participant

                                            Kevin,

                                            I also tried the Yervoy route with no luck. Then IL2 – again no luck. I'm still hoping that maybe one or both of these treatments kick in late and do some good but I can't wait on that. Going to try another trial in a week and I understand there are others but I need get off this steroid first. The way I see it why not keep getting up to bat and give it a go – what else is there to do anyway?

                                            Keep at it and good luck,

                                            Dave G

                                            KevinM
                                            Participant

                                              Kevin,

                                              I don't have any advice  for you….just that you are in my thoughts and prayers. Keep fighting! I hope the next treatment plan is the one that gives you long term success!

                                              take good care!
                                              Kevin 

                                              KevinM
                                              Participant

                                                Kevin,

                                                I don't have any advice  for you….just that you are in my thoughts and prayers. Keep fighting! I hope the next treatment plan is the one that gives you long term success!

                                                take good care!
                                                Kevin 

                                                KevinM
                                                Participant

                                                  Kevin,

                                                  I don't have any advice  for you….just that you are in my thoughts and prayers. Keep fighting! I hope the next treatment plan is the one that gives you long term success!

                                                  take good care!
                                                  Kevin 

                                                  scots
                                                  Participant

                                                    Keep Fighting and you are in my prayers.

                                                     

                                                    scot

                                                    scots
                                                    Participant

                                                      Keep Fighting and you are in my prayers.

                                                       

                                                      scot

                                                        Laurie from maine
                                                        Participant

                                                          I have been thinking and praying for you.  Good for you for getting all your information off as soon as possible and I am hopeful they can find a plan for you and can take you.   

                                                          The positive news is there seems to be more and more trials coming out and one of them will be the winner for you, you are young and strong and such an amazing attitude!!.  I do hope the yervoy is just taking it time and will kick in for you.

                                                          take care, keep us posted, stay strong!

                                                          laurie from maine

                                                          Laurie from maine
                                                          Participant

                                                            I have been thinking and praying for you.  Good for you for getting all your information off as soon as possible and I am hopeful they can find a plan for you and can take you.   

                                                            The positive news is there seems to be more and more trials coming out and one of them will be the winner for you, you are young and strong and such an amazing attitude!!.  I do hope the yervoy is just taking it time and will kick in for you.

                                                            take care, keep us posted, stay strong!

                                                            laurie from maine

                                                            Laurie from maine
                                                            Participant

                                                              I have been thinking and praying for you.  Good for you for getting all your information off as soon as possible and I am hopeful they can find a plan for you and can take you.   

                                                              The positive news is there seems to be more and more trials coming out and one of them will be the winner for you, you are young and strong and such an amazing attitude!!.  I do hope the yervoy is just taking it time and will kick in for you.

                                                              take care, keep us posted, stay strong!

                                                              laurie from maine

                                                            scots
                                                            Participant

                                                              Keep Fighting and you are in my prayers.

                                                               

                                                              scot

                                                              jim Breitfeller
                                                              Participant

                                                                Kevin,

                                                                I been following a new Clinical trial at the NCI with Rosenberg. It uses modified T-cells to secrete IL-12 into the tumor's miroenviroment. This will shift the T-cell differentiation toward the Th1 phenotype (the good helper cells). This IL-12 also help activate the CD8 T-cell (CTLs)  Tumor Killing cells. You might want to see about this one.

                                                                I have been studing how to activate the "Danger signal" to help get the immune response started.. It can be done a number of ways but not all have been clinically tested. 

                                                                You can involke an immune response by the innate immune systems. This entails using the (TLRs) Toll Like receptors.

                                                                If you combine the TLR4 and TLR9 actiavtion you can induce an immune response that secretes IL-6,IL-1, TNF and mostly IL-12. If you add PI3K inhibitor in the mix, the outcome is the Th1 T-cells with very few new Tregs. Tregs are suppressive to the immune response.

                                                                 The bottom line is Rosenberg's Trial is the most cutting edge technology out there.

                                                                The second best is the combination of Yervoy and Anti-PD-1. This trial not only knocks out the Treg's function, but also fixes the T-cell exhuastion with Anti-PD-1. The problem here is you still need the "danger signal" to get the T-cells activated and homing to the point of danger, the tumor's microenvirnoment.

                                                                 

                                                                I wish you well in your path forward.

                                                                 

                                                                Jimmy B

                                                                jim Breitfeller
                                                                Participant

                                                                  Kevin,

                                                                  I been following a new Clinical trial at the NCI with Rosenberg. It uses modified T-cells to secrete IL-12 into the tumor's miroenviroment. This will shift the T-cell differentiation toward the Th1 phenotype (the good helper cells). This IL-12 also help activate the CD8 T-cell (CTLs)  Tumor Killing cells. You might want to see about this one.

                                                                  I have been studing how to activate the "Danger signal" to help get the immune response started.. It can be done a number of ways but not all have been clinically tested. 

                                                                  You can involke an immune response by the innate immune systems. This entails using the (TLRs) Toll Like receptors.

                                                                  If you combine the TLR4 and TLR9 actiavtion you can induce an immune response that secretes IL-6,IL-1, TNF and mostly IL-12. If you add PI3K inhibitor in the mix, the outcome is the Th1 T-cells with very few new Tregs. Tregs are suppressive to the immune response.

                                                                   The bottom line is Rosenberg's Trial is the most cutting edge technology out there.

                                                                  The second best is the combination of Yervoy and Anti-PD-1. This trial not only knocks out the Treg's function, but also fixes the T-cell exhuastion with Anti-PD-1. The problem here is you still need the "danger signal" to get the T-cells activated and homing to the point of danger, the tumor's microenvirnoment.

                                                                   

                                                                  I wish you well in your path forward.

                                                                   

                                                                  Jimmy B

                                                                    jim Breitfeller
                                                                    Participant

                                                                      Kevin,

                                                                      I forgot one thing. If you do BRAF, try to get it in combination with MEK inhibitor.  Melanoma seems to find its way around the Braf pathway. So blocking both pathways lowers the chances that Melanoma will circumvent the pathways.

                                                                       

                                                                      Best regards,

                                                                      Jimmy B

                                                                      jim Breitfeller
                                                                      Participant

                                                                        Kevin,

                                                                        I forgot one thing. If you do BRAF, try to get it in combination with MEK inhibitor.  Melanoma seems to find its way around the Braf pathway. So blocking both pathways lowers the chances that Melanoma will circumvent the pathways.

                                                                         

                                                                        Best regards,

                                                                        Jimmy B

                                                                        jim Breitfeller
                                                                        Participant

                                                                          Kevin,

                                                                          I forgot one thing. If you do BRAF, try to get it in combination with MEK inhibitor.  Melanoma seems to find its way around the Braf pathway. So blocking both pathways lowers the chances that Melanoma will circumvent the pathways.

                                                                           

                                                                          Best regards,

                                                                          Jimmy B

                                                                        jim Breitfeller
                                                                        Participant

                                                                          Kevin,

                                                                          I been following a new Clinical trial at the NCI with Rosenberg. It uses modified T-cells to secrete IL-12 into the tumor's miroenviroment. This will shift the T-cell differentiation toward the Th1 phenotype (the good helper cells). This IL-12 also help activate the CD8 T-cell (CTLs)  Tumor Killing cells. You might want to see about this one.

                                                                          I have been studing how to activate the "Danger signal" to help get the immune response started.. It can be done a number of ways but not all have been clinically tested. 

                                                                          You can involke an immune response by the innate immune systems. This entails using the (TLRs) Toll Like receptors.

                                                                          If you combine the TLR4 and TLR9 actiavtion you can induce an immune response that secretes IL-6,IL-1, TNF and mostly IL-12. If you add PI3K inhibitor in the mix, the outcome is the Th1 T-cells with very few new Tregs. Tregs are suppressive to the immune response.

                                                                           The bottom line is Rosenberg's Trial is the most cutting edge technology out there.

                                                                          The second best is the combination of Yervoy and Anti-PD-1. This trial not only knocks out the Treg's function, but also fixes the T-cell exhuastion with Anti-PD-1. The problem here is you still need the "danger signal" to get the T-cells activated and homing to the point of danger, the tumor's microenvirnoment.

                                                                           

                                                                          I wish you well in your path forward.

                                                                           

                                                                          Jimmy B

                                                                          Ali
                                                                          Participant

                                                                            I just want to wish you my best and hope you get a plan quick.  Glad you are feeling okay, hang in there!

                                                                            Ali

                                                                            Ali
                                                                            Participant

                                                                              I just want to wish you my best and hope you get a plan quick.  Glad you are feeling okay, hang in there!

                                                                              Ali

                                                                              Ali
                                                                              Participant

                                                                                I just want to wish you my best and hope you get a plan quick.  Glad you are feeling okay, hang in there!

                                                                                Ali

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