Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC

NCT01437605 | Terminated Phase 2 Results DMC

• 1 other identifier: MCC-16545
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 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. 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.

Conditions

Melanoma

Keywords

Resected; Skin; Stage IV

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Related to Study Treatment

  Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC

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

Secondary Outcomes (3)

• Immunogenicity Per Treatment Arm

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

• Percentage of Participants With Relapse-Free Survival (RFS)

  Beginning of Treatment to End of Follow Up - up to 2 years per participant

• Median Overall Survival (OS)

  At 5 years

Other Outcomes (2)

• Immunogenicity as Measured by T Cell Responses

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

• Correlation Between Gene Expression Profile and Treatment Clinical Activity

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

Study Arms (2)

A: recMAGE-A3 + AS15

ACTIVE COMPARATOR

ASCI injections without Poly IC:LC

Drug: MAGE-A3 ASCI injections without Poly IC:LC

B: recMAGE-A3 + AS15 + Poly IC:LC

ACTIVE COMPARATOR

ASCI injections with Poly IC:LC

Drug: MAGE-A3 ASCI injections with Poly IC:LC

Interventions

MAGE-A3 ASCI injections without Poly IC:LC DRUG

MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description

Also known as: Recombinant MAGE-A3 protein, AS15 adjuvant

A: recMAGE-A3 + AS15

MAGE-A3 ASCI injections with Poly IC:LC DRUG

MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description

Also known as: Recombinant MAGE-A3 protein, AS15 adjuvant, Hiltonol, NSC 301463

B: recMAGE-A3 + AS15 + Poly IC:LC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient has an ocular melanoma.
• The patient has in-transit metastases.
• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• GlaxoSmithKline: collaborator
• Oncovir, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Nikhil Khushalani
• Organization: Moffitt Cancer Center

Nikhil.Khushalani@Moffitt.org

813-745-3437

Study Officials

• Nikhil Khushalani, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 21, 2011
• Study Start: October 11, 2011
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: December 20, 2019
• Results First Posted: December 20, 2019

Record last verified: 2019-12

Locations

US (1)