Overview

This trial is active, not recruiting.

Condition melanoma
Treatments mage-a3 asci injections without poly ic:lc, mage-a3 asci injections with poly ic:lc
Phase phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator GlaxoSmithKline
Start date October 2011
End date March 2017
Trial size 14 participants
Trial identifier NCT01437605, MCC-16545

Summary

The overall purpose of this research study is to find a better way to treat melanoma.

The goals of this study are:

1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC

2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with or without the Poly IC:LC

3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC

4. To measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
ASCI injections without Poly IC:LC
mage-a3 asci injections without poly ic:lc Recombinant MAGE-A3 protein
MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
(Active Comparator)
ASCI injections with Poly IC:LC
mage-a3 asci injections with poly ic:lc Recombinant MAGE-A3 protein
MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description

Primary Outcomes

Measure
Number of Participants With Adverse Events Related to Study Treatment
time frame: Up to 30 Months

Secondary Outcomes

Measure
Immunogenicity Per Treatment Arm
time frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant
Median Relapse-Free Survival (RFS)
time frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant
Median Overall Survival (OS)
time frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Nikhil Khushalani, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.