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A Randomized Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC in Patients With Resected MAGE-A3 Positive, Stage IV Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

A Randomized Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC in Patients With Resected MAGE-A3 Positive, Stage IV Melanoma


In the first year, participants may receive up to 8 injections given in the following order:

1. 5 ASCI injections with or without Poly IC:LC with a 3-week interval between each.

2. 3 ASCI injections with or without Poly IC:LC with a 3-month interval between each.

During years 2 through 3, participants may receive up to 5 ASCI injections with or
without Poly IC:LC given in the following order:

3. During year 2, ASCI injections with or without Poly IC:LC will be given every 3 months
for a total of up to 3 injections.

4. During year 3, ASCI injections with or without Poly IC:LC will continue to be given
every 3 months for a total of up to 2 more injections.


Inclusion Criteria:



- Written informed consent for the study will be obtained prior to the performance of
MAGE-A3 expression screening on resected tumor tissue or any other protocol-specific
procedure.

- Male or female patient with histologically proven and completely resected stage IV
cutaneous or mucosal melanoma. In terms of the American Joint Committee on Cancer
(AJCC) classification [AJCC, 2009], this means that patients with resected M1a-b-c
(stage IV) disease may be enrolled.

- The patient must have been surgically rendered free of disease no more than 12 weeks
before the randomization.

- Patient is equal to or greater than 18 years old at the time of signing the informed
consent form.

- The patient's tumor shows expression of the MAGE-A3 gene, as determined by Reverse
Transcriptase Polymerase Chain Reaction (RT-PCR) analysis on paraffin imbedded tumor
tissue (FFPE). In all patients in whom it can be obtained, a frozen portion of the
resected tumor will be analyzed for gene profiling.

- The patient has fully recovered from surgery.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of
randomization.

- The patient must have adequate bone-marrow reserve, adequate renal function and
adequate hepatic function as assessed by standard laboratory criteria: Absolute
neutrophil count (ANC) equal to or greater than 1.5 x 10^9/L, Platelet count equal
to or greater than 75 x 10^9/L, Serum creatinine equal to or less than 1.5 times the
Upper Limit of Normal (ULN), Total bilirubin equal to or less than 1.5 times the ULN,
Transaminase (ALT - AST) equal to or less than 2.5 times the ULN

- If the patient is female, she must be of non-childbearing potential, i.e. have a
current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is
of childbearing potential, she must practice adequate contraception for 30 days prior
to randomization, have a negative pregnancy test and continue such precautions during
the entire study treatment period and for 2 months after completion of the injection
series.

- Men must also agree to use an adequate method of contraception.

- In the opinion of the investigator, the patient can and will comply with all the
requirements of the protocol.

Exclusion Criteria:

- The patient has an ocular melanoma.

- The patient has in-transit metastases.

- The patient has been treated or is scheduled to be treated with an adjuvant
anticancer therapy after the metastasectomy that qualifies the patient for inclusion
in the present trial.

- One prior systemic treatment with an immunomodulator (i.e., interferon, vaccine
and/or anti-CTLA-4) after a previous surgery is permitted, provided that the last
dose has been administered at least 45 days before randomization in the present
trial.

- Previous radiotherapy is permitted, provided that the treatment has been completed
before the surgery that qualifies the patient for participation in the present trial.

- The patient requires concomitant chronic treatment (more than 7 consecutive days)
with systemic corticosteroids or any other immunosuppressive agents. The use of
prednisone, or equivalent, at a dose of < 0.125 mg/kg/day (absolute maximum 10
mg/day) or topical steroids is permitted.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study treatment within 30 days preceding the randomization or planned use during the
study period.

- The patient has a history of autoimmune disease such as, but not limited to, multiple
sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not
excluded.

- The patient has a family history of congenital or hereditary immunodeficiency.

- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has
another confirmed or suspected immunosuppressive or immunodeficient condition.

- History of allergic disease or reactions likely to be exacerbated by any component of
the treatments.

- The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent or to comply with the trial procedures.

- The patient has concurrent severe medical problems, unrelated to the malignancy, that
would significantly limit full compliance with the study or expose the patient to
unacceptable risk.

- The patient has previous or concomitant malignancies at other sites, except
effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or
effectively treated malignancy that has been in remission for over 5 years and is
highly likely to have been cured.

- The patient has an uncontrolled bleeding disorder.

- For female patients: the patient is pregnant or lactating.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events

Outcome Description:

Toxicity and tolerability in the two study arms (recMAGE-A3 + AS15 ASCI and recMAGE-A3 + AS15 ASCI in combination with Poly IC:LC) defined by the adverse events and serious adverse events. Adverse events (AEs), including abnormal laboratory values, will be graded according to the Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0 and coded to the preferred term (PT) level using the Medical Dictionary for Regulatory Activities (MedDRA) dictionary.

Outcome Time Frame:

Beginning of Treatment to End of Follow Up - up to 5 years per participant

Safety Issue:

Yes

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-16545

NCT ID:

NCT01437605

Start Date:

October 2011

Completion Date:

January 2019

Related Keywords:

  • Melanoma
  • Resected
  • Skin
  • Stage IV
  • Melanoma

Name

Location

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