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MelanomaPhase 2NCT01437605

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

A Phase 2 study testing MAGE-A3 ASCI injections without Poly IC:LC and MAGE-A3 ASCI injections with Poly IC:LC in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
MAGE-A3 ASCI injections without Poly IC:LC and MAGE-A3 ASCI injections with Poly IC:LC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
11 Oct 2011to 18 Jul 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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.
Read the detailed 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.
Conditions
Melanoma
Being tested
MAGE-A3 ASCI injections without Poly IC:LC, MAGE-A3 ASCI injections with Poly IC:LC
Keywords
Resected, Skin, Stage IV
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAGE-A3 ASCI injections without Poly IC:LCDrug

    Also called Recombinant MAGE-A3 protein, AS15 adjuvant

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

  • MAGE-A3 ASCI injections with Poly IC:LCDrug

    Also called Recombinant MAGE-A3 protein, AS15 adjuvant, Hiltonol, NSC 301463

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

Study groups in NCT01437605
Study groupRoleWhat they receive
A: recMAGE-A3 + AS15Active comparatorASCI injections without Poly IC:LC
Receives: Drug: MAGE-A3 ASCI injections without Poly IC:LC
B: recMAGE-A3 + AS15 + Poly IC:LCActive comparatorASCI injections with Poly IC:LC
Receives: Drug: MAGE-A3 ASCI injections with Poly IC:LC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (3)

  1. Immunogenicity Per Treatment Arm

    Laboratory Endpoint: Assessment of the immunogenicity of the two regimens. Serum antibodies (such as Anti-MAGE-A3) seropositivity status (a seropositive patient is a patient whose titre is greater than or equal to the cut-off value) will be the primary immune endpoints assessed. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2).

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

  2. Percentage of Participants With Relapse-Free Survival (RFS)

    RFS, defined as the time from randomization to the date of first relapse of melanoma or of death, whichever comes first. Percentage of participants with RFS, assessed up to 2 years is reported

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

  3. Median Overall Survival (OS)

    OS defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last assessment. The primary analysis will be based on the adjusted Cox regression model.

    Measured: At 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2011 (estimated)
  2. Study start11 Oct 2011
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 2018

Why it stopped: Treatment Ineffective

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01437605
Sponsor's protocol ID
MCC-16545
Status last verified
Dec 2019
First submitted
19 Sep 2011
Last updated
20 Dec 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MAGE-A3 ASCI injections without Poly IC:LC and MAGE-A3 ASCI injections with Poly IC:LC in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events Related to Study Treatment (time frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.

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