Lost and Looking for guidance PLEASE

Maybe he can get into this trial…I am currently on this exact trial except I am NED . It is offered to those who are NED and is also offered in a separate trial for thos who are not. (.MDX-1106  is now called BMS-936558 because Bristol Myers Squibb bought it from Medarex)…

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

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.

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

   

• 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

   

• 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)

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

30

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.

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]

Maybe he can get into this trial…I am currently on this exact trial except I am NED . It is offered to those who are NED and is also offered in a separate trial for thos who are not. (.MDX-1106  is now called BMS-936558 because Bristol Myers Squibb bought it from Medarex)…

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

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.

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

   

• 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

   

• 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)

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

30

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.

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]