What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immunotherapies like peptide vaccines with adjuvants and monoclonal antibodies (e.g., CDX-1127), often have side effects such as immune-mediated adverse events. These can include skin reactions, colitis, hepatitis, endocrinopathies, and pneumonitis. Targeted therapies, especially those for BRAF V600-mutated tumors, can cause fever, fatigue, joint pain, and skin issues. It's important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of melanoma, focusing on enhancing the immune response. Notable approvals include immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target the PD-1 pathway, and ipilimumab, which targets CTLA-4. These treatments have shown efficacy in improving progression-free survival and overall survival in patients with advanced melanoma. Additionally, combination therapies like nivolumab plus ipilimumab have been approved for their synergistic effects. While the peptide vaccine 6MHP with adjuvants and CDX-1127 is investigational, it aligns with the broader strategy of using immunotherapy to boost the body's immune response against melanoma.

What other types of research exist?

Promising novel alternatives for melanoma treatment in 2024 include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance immune response against melanoma cells. 2) Combination therapies involving immune checkpoint inhibitors and targeted therapies like BRAF and MEK inhibitors (e.g., dabrafenib and trametinib) for patients with specific genetic mutations. 3) Adoptive cell transfer therapies, including TIL (tumor-infiltrating lymphocytes) therapy, which involves expanding and reinfusing a patient's own immune cells to target melanoma. 4) Novel vaccines and oncolytic virus therapies that stimulate the immune system to attack melanoma cells. These alternatives have shown promising results in clinical trials and may offer effective treatment options for melanoma patients.

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Cancer Vaccine

Cancer Vaccine +/− CDX-1127 for Melanoma (Mel-65 Trial)

Phase 1 & 2

Waitlist Available

Led By Craig L Slingluff, Jr., MD

Research Sponsored by Craig L Slingluff, Jr

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1

Age 18 years or older at registration

Must not have

Prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded

Participants who have received a live vaccine within 30 days of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a peptide vaccine combined with boosters and a special antibody is safe and can improve immune responses. The study will check blood and tissue samples to see how well the treatment works.

Who is the study for?

This trial is for adults over 18 with stage II-IV melanoma, who are currently free of disease post-treatment or surgery. They must have good performance status and organ function, not be pregnant or breastfeeding, and without a history of certain autoimmune disorders or recent treatments that could interfere with the study.

What is being tested?

The trial tests the safety and immune response to a peptide vaccine (6MHP) combined with adjuvants Montanide ISA-51 and polyICLC, plus CDX-1127 monoclonal antibody in some participants. It's evaluating if these substances can boost the body's defense against melanoma when given together.

What are the potential side effects?

Potential side effects may include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever or fatigue, allergic responses to vaccine components, and possible immune-related effects due to CDX-1127.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are in good enough physical condition to perform daily activities without help or with a little help.

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You may have had different types of melanoma, but it needs to be confirmed by a specific type of examination. If you have cutaneous melanoma, it will be staged using a specific system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have a history of serious autoimmune disorders that required strong medication to treat.

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You have received treatment with CDX-1127 or a similar type of medication before.

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You have received the 6MHP vaccine before.

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You have had lung inflammation caused by an autoimmune condition before.

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You have severe heart disease classified as Class III or IV by the New York Heart Association.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immunogenicity-Percent of patients with persistent CD4+ T cell responses to the 6MHP vaccine

Safety of CDX-1127 administered with a melanoma vaccine

Secondary study objectives

Immunogenicity - Frequency of circulating CD4+ Th1 responses

Immunogenicity-Frequency of CD4+ Th1 memory responses

Immunogenicity-Frequency of durable CD4+ Th1 memory responses

+2 more

Side effects data

From 2020 Phase 1 & 2 trial • 22 Patients • NCT02515227

100%

Injection site reaction

83%

Skin induration

67%

Fatigue

50%

Fever

50%

Pruritis

50%

Rash maculo-papular

33%

Myalgia

33%

Arthralgia

33%

Lymphocyte count decreased

33%

Bruising

17%

Dyspnea

17%

Anemia

17%

Chills

17%

Flu-like symptoms

17%

Aspartate aminotransferase increased

17%

Hyperuricemia

17%

Headache

17%

Allergic rhinitis

17%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

6MHP + Pembrolizumab (PD-1 Antibody-naive Cohort)

6MHP + Pembrolizumab (PD-1 Antibody-experienced Cohort)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: 6MHP/Montanide ISA-51 + polyICLCExperimental Treatment3 Interventions

200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176.

Group II: Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

polyICLC

2018

Completed Phase 2

~40

Montanide ISA-51

1999

Completed Phase 2

~340

6MHP

2020

Completed Phase 2

~120

CDX-1127

2011

Completed Phase 2

~130

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma, such as immune checkpoint inhibitors (e.g., nivolumab and ipilimumab) and peptide vaccines, work by enhancing the body's immune response against cancer cells. Immune checkpoint inhibitors block proteins that prevent T-cells from attacking cancer cells, thereby boosting the immune system's ability to target and destroy melanoma cells. Peptide vaccines, like the 6MHP with adjuvants, introduce specific antigens to the immune system, prompting it to recognize and attack melanoma cells more effectively. The addition of adjuvants and monoclonal antibodies like CDX-1127 further amplifies this immune response. These mechanisms are crucial for melanoma patients as they can lead to more effective and durable responses against the cancer, potentially improving survival rates and quality of life.

A Bayesian network meta-analysis of comparison of cancer therapeutic vaccines for melanoma.