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A Phase I Trial of a Vaccine Combining Multiple Class I Peptides and Montanide ISA 51 VG With Escalating Doses of Anti-PD-1 Antibody BMS-936558 for Patients With Resected Stage IIIC/IV Melanoma


Phase 1
16 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

A Phase I Trial of a Vaccine Combining Multiple Class I Peptides and Montanide ISA 51 VG With Escalating Doses of Anti-PD-1 Antibody BMS-936558 for Patients With Resected Stage IIIC/IV Melanoma


This phase I trial is studying the side effects and best dose of anti-PD-1 human monoclonal
antibody MDX-1106 when given together with and vaccine therapy in treating patients with
stage IIIC or stage IV melanoma that has been removed by surgery.

Blood and serum samples are collected periodically for immunology and pharmacokinetic
studies.

After completion of study treatment, patients are followed up for up to 2 years.


Inclusion Criteria:



- Histologic diagnosis of resected Stages IIIC/ IV melanoma, with no evidence of
disease clinically and radiologically. All melanomas regardless of primary site of
disease will be allowed.

- HLA-A*0201 positive as determined by deoxyribonucleic (DNA) allele-specific
polymerase chain reaction (PCR) assay

- Positive staining of most recently resected tumor tissue with antibodies to 1 or more
of the following: human melanoma black 45 (HMB 45) for gp100, NY-ESO-1, and/or MART-1

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given
to control the cancer) must have been completed at least 4 weeks before study drug
administration, and all adverse events have either returned to baseline or
stabilized.

- Prior treated brain or meningeal metastases must be without magnetic resonance
imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive
doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2
weeks before study drug administration.

- Prior systemic radiation therapy must have been completed at least 4 weeks before
study drug administration. Prior focal radiotherapy completed at least 2 weeks before
study drug administration. No radiopharmaceuticals (strontium, samarium) within 8
weeks before study drug administration.

- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical
steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2
weeks before study drug administration.

- Completed nitrosourea treatment at least 6 weeks before administration of any study
drug.

- Prior surgery that required general anesthesia must be completed at least 4 weeks
before study drug administration. Surgery requiring local/epidural anesthesia must be
completed at least 72 hours before study drug administration and participants should
be recovered.

- Screening laboratory values must meet the following criteria: white blood cells
(WBCs) ≥ 2000 cells/μL, neutrophils ≥ 1500 cells/μL, platelets ≥ 100 x 10^3/μL,
hemoglobin ≥ 9.0 g/dL, serum creatinine ≤ 2 mg/dL, aspartic transaminase (AST) ≤ 2.5
x upper limit of normal (ULN) without, and ≤ 5 x ULN with hepatic metastasis, alanine
transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis,
bilirubin ≤ 2 x ULN (except participants with Gilbert's syndrome, who must have total
bilirubin < 3.0 mg/dL).

- Females of childbearing potential (FOCBP) must: Agree to use using a reliable form of
contraception (eg, oral contraceptives, intrauterine device, double barrier method of
condom and spermicidal) for at least 28 days prior to the first dose of any study
drug, during the Treatment Period (and Treatment/Follow-up if receiving study drug),
and for at least 70 days after the last dose of any study drug; have a negative serum
β-human chorionic gonadotropin (β-HCG) at Screening.

- For female participants to be considered as not having childbearing potential, they
must meet 1 or more of the following criteria: postmenopausal for at least 24
consecutive months; surgically sterile (ie, have had a hysterectomy or bilateral
oophorectomy); females with irregular menstrual periods and/or on hormone replacement
therapy must have a documented serum follicle stimulating hormone level > 35 mIU/mL.

- Male participants must agree to the use of male contraception during the Treatment
Period and for at least 180 days after the last dose of any study drug.

- Must have read, understood, and provided written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) authorization after the nature
of the study has been fully explained.

- Willing to adhere to the study visit schedule and the prohibitions and restrictions
specified in this protocol.

Exclusion Criteria:

- History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).

- Systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component.

- Prior non-melanoma malignancy active within the previous 2 years except for locally
curable cancers that have been apparently cured, such as basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or
breast.

- Any active autoimmune disease or documented history of autoimmune disease, or history
of syndrome that required systemic steroids or immunosuppressive medications, except
for participants with vitiligo or resolved childhood asthma/atopy.

- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS).

- Positive tests for hepatitis B virus surface antigen (HBV SAg) or hepatitis C virus
ribonucleic acid (HCV RNA) indicating active or chronic infection.

- Prior therapy with an anti-Programmed Death-1(anti-PD-1), anti-Programmed
Death-Ligand 1 (anti-PD-L1), anti-programmed death-ligand-2 (anti-PDL-2), or
anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody(or any other
antibody targeting T cell co-stimulation pathways).

- Concurrent medical condition requiring the use of immunosuppressive medications, or
immunosuppressive doses of systemic or absorbable topical corticosteroids.

- Underlying medical condition (eg, a condition associated with diarrhea) that, in the
Investigator's opinion, would make the administration of either study drug or both
study drugs hazardous to the participant or obscure the interpretation of toxicity
determination or adverse events.

- Pregnant or nursing.

- Current participation in another clinical study involving treatment with medications,
radiation or surgery, or prior participation in this study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Relapse

Outcome Description:

The primary efficacy analysis is time to relapse, to determine relapse at the end of each cycle (Weeks 12 and 24). Time to relapse will be summarized using descriptive statistics.

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Jeffrey S. Weber, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-15651

NCT ID:

NCT01176474

Start Date:

July 2010

Completion Date:

December 2013

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • stage IIIC melanoma
  • Melanoma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612