C. Slingluff from UVA – PD-1 Slsides

You've got that right!  Dr Slingluff is the best and so is his amazing staff.  He is truly dedicated to his profession and his patients.  Beth 3/B

You've got that right!  Dr Slingluff is the best and so is his amazing staff.  He is truly dedicated to his profession and his patients.  Beth 3/B

You've got that right!  Dr Slingluff is the best and so is his amazing staff.  He is truly dedicated to his profession and his patients.  Beth 3/B

PS  as part of the trial I have to do the booster of MDX 1106 for 2 years…and Dr Weber says if I remain NED I may want to consider staying on it indefinately.

I am going to e-mail Dr W tonight and ask him about the antibodies for anti pd 1.

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

I am not sure if it was  for the anti-pd-1 or for the peptides, but I had to have one of the following  antibodies : HMB 45 for gp 100, NY-ESO-1, and /or MART-1 and I had to have  the  A0201.

My highs are A 0101, A0201, B 0801, B 04492, Cw 0501, Cw 0701,

I have Mart-1(Melan A)  and HMB 45 ( gp 100) I was negative for NY ESO-1.

They are aslo running a sister trial with same components for unresected   however exclusion criteria is different. My trial  said : No prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways).

This  sister trial allows prior use of IPI in 4th and 5th cohort  and acccepts  Stage III and Stage 4

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed melanoma
  • Unresectable stage III or IV disease
  • HLA-A*0201 positive by DNA allele-specific PCR assay

   

• 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 and 5)

   

• 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
  • 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 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
  • 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 allowedNo 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

I am going to e-mail Dr W tonight and ask him about the antibodies for anti pd 1.

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

I am not sure if it was  for the anti-pd-1 or for the peptides, but I had to have one of the following  antibodies : HMB 45 for gp 100, NY-ESO-1, and /or MART-1 and I had to have  the  A0201.

My highs are A 0101, A0201, B 0801, B 04492, Cw 0501, Cw 0701,

I have Mart-1(Melan A)  and HMB 45 ( gp 100) I was negative for NY ESO-1.

They are aslo running a sister trial with same components for unresected   however exclusion criteria is different. My trial  said : No prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways).

This  sister trial allows prior use of IPI in 4th and 5th cohort  and acccepts  Stage III and Stage 4

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed melanoma
  • Unresectable stage III or IV disease
  • HLA-A*0201 positive by DNA allele-specific PCR assay

   

• 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 and 5)

   

• 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
  • 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 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
  • 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 allowedNo 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

I am going to e-mail Dr W tonight and ask him about the antibodies for anti pd 1.

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

I am not sure if it was  for the anti-pd-1 or for the peptides, but I had to have one of the following  antibodies : HMB 45 for gp 100, NY-ESO-1, and /or MART-1 and I had to have  the  A0201.

My highs are A 0101, A0201, B 0801, B 04492, Cw 0501, Cw 0701,

I have Mart-1(Melan A)  and HMB 45 ( gp 100) I was negative for NY ESO-1.

They are aslo running a sister trial with same components for unresected   however exclusion criteria is different. My trial  said : No prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways).

This  sister trial allows prior use of IPI in 4th and 5th cohort  and acccepts  Stage III and Stage 4

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed melanoma
  • Unresectable stage III or IV disease
  • HLA-A*0201 positive by DNA allele-specific PCR assay

   

• 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 and 5)

   

• 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
  • 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 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
  • 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 allowedNo 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

PS  as part of the trial I have to do the booster of MDX 1106 for 2 years…and Dr Weber says if I remain NED I may want to consider staying on it indefinately.

PS  as part of the trial I have to do the booster of MDX 1106 for 2 years…and Dr Weber says if I remain NED I may want to consider staying on it indefinately.