What is the mechanism of action of this treatment?

Common treatments for melanoma, particularly advanced stages, often involve immunotherapy approaches that harness the body's immune system to target and destroy cancer cells. Treatments like the Personalized Neo-Antigen Peptide Vaccine work by inducing a polyclonal, poly-epitope, cytolytic T cell immunity against the tumor. This means they stimulate the patient's immune system to recognize and attack multiple specific antigens present on the melanoma cells, leading to a more robust and targeted immune response. This is crucial for melanoma patients as it can potentially lead to more effective and durable responses compared to traditional therapies, which may not be as specific or long-lasting.

What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immunotherapies like immune checkpoint inhibitors (e.g., ipilimumab, nivolumab) and personalized vaccines, can cause immune-related adverse events. These side effects often include inflammation in various organs, leading to colitis, hepatitis, dermatitis, and endocrinopathies. Other common side effects are fatigue, fever, and injection site reactions. Severe, life-threatening immune-mediated reactions can also occur and require immediate medical attention.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of advanced melanoma, focusing on enhancing the body's immune response to target cancer cells. Notable approvals include checkpoint inhibitors like nivolumab and ipilimumab, which block proteins that prevent T cells from attacking cancer cells, thereby inducing a robust immune response. Additionally, pembrolizumab, another checkpoint inhibitor, has been approved for melanoma with high tumor mutational burden or mismatch repair deficiency. These treatments aim to stimulate a polyclonal, poly-epitope, cytolytic T cell immunity, similar to the approach being studied in the Personalized Neo-Antigen Peptide Vaccine trial.

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 T cell responses. 2) Combination therapies like nivolumab with ipilimumab, which target multiple immune checkpoints for a synergistic effect. 3) Talimogene laherparepvec (T-VEC) combined with pembrolizumab, an oncolytic virus therapy that enhances anti-tumor immunity. 4) Experimental approaches such as CAR-T cell therapies and other personalized immunotherapies being tested in clinical trials.

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Cancer Vaccine

Cancer Vaccine for Melanoma

Phase 1

Recruiting

Led By Joshua Veatch

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Toxicity from prior therapy must be recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5 grade 2 or less

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

Must not have

Female patients who are lactating or intend to breastfeed during the duration of the study

Patients with active infection causing fever or unexplained fever

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post first vaccination

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a custom-made vaccine for patients with advanced melanoma or breast cancer that has spread or is resistant to treatment. The vaccine helps the immune system recognize and attack cancer cells using specific markers from the patient's tumor, boosted by additional substances. Melanoma has been a model disease for testing novel vaccine designs due to its intrinsic immunogenicity.

Who is the study for?

Adults over 18 with advanced melanoma or hormone receptor positive, HER2 negative breast cancer that's spread or is treatment-resistant. They must be in good enough health to participate, have measurable disease, and agree to follow the study plan. People with heart issues, severe liver problems, certain blood conditions or active infections can't join. Women of childbearing age must use contraception.

What is being tested?

The trial tests a personalized neo-antigen peptide vaccine combined with an adjuvant called poly ICLC on patients with specific types of melanoma and breast cancer. The goal is to see if this vaccine can trigger the body's T cells to fight the patient’s tumor more effectively.

What are the potential side effects?

Potential side effects may include typical immune responses like fever and fatigue as well as site-specific reactions such as redness or pain where the vaccine was injected. There could also be more serious immune-related side effects due to activation of T cells.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from previous cancer treatment side effects to a mild level.

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I can take care of myself and am up and about more than half of my waking hours.

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I do not have, nor have I had, lung conditions needing steroid treatment.

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I know my melanoma's BRAF mutation status.

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My liver function tests are within the required range.

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My kidney function is normal, with creatine below 1.5 mg/dL or eGFR above 60 mL/min.

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I have mild or no shortness of breath and my oxygen levels are above 92% without extra oxygen.

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I have breast cancer that came back or didn't go away after treatment.

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I have a tumor or tumors that can be biopsied or removed.

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I have melanoma and it came back after I received the standard treatment.

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My melanoma diagnosis was confirmed with a tissue test.

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I have not had serious heart issues or uncontrolled infections recently.

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My breast cancer is hormone receptor positive and HER2 negative.

Exclusion Criteria

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

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I am currently breastfeeding or plan to during the study.

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I currently have a fever due to an infection.

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My autoimmune disease has been uncontrolled for the last year despite treatment.

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I currently have an infection that isn't under control.

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I have breast cancer with symptoms due to lung, bone marrow, or liver spread.

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I have not received a live vaccine in the last 30 days.

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My melanoma is specifically in the eye (uveal or choroidal).

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I have a known immune system deficiency.

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I have pain from my cancer that isn't relieved by treatment.

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I have brain metastases that cause symptoms.

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I need frequent drainage for fluid buildup in my chest or abdomen more than once a month.

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I stopped a PD-1 inhibitor treatment due to a severe immune-related side effect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post first vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post first vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post first vaccination for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Best overall response

Evaluation of target lesion

Progression-free survival

Side effects data

From 2018 Phase 2 trial • 60 Patients • NCT02129075

100%

General disorders and administration site conditions

67%

Musculoskeletal and connective tissue disorders

57%

Nervous system disorders

50%

Skin and subcutaneous tissue disorders

50%

Gastrointestinal disorders

50%

Metabolism and nutrition disorders

47%

Investigations

43%

Blood and lymphatic system disorders

43%

Respiratory, thoracic and mediastinal disorders

33%

Injury, poisoning and procedural complications

27%

Vascular disorders

23%

Infections and infestations

20%

Psychiatric disorders

13%

Eye disorders

10%

Ear and labyrinth disorders

10%

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Surgical and medical procedures

Renal and urinary disorders

Reproductive system and breast disorders

Cardiac disorders

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (CDX-301, CDX-1401, and Poly-ICLC)

Arm II (CDX-1401 and Poly-ICLC)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (poly ICLC, PNV21 vaccine, nivolumab)Experimental Treatment10 Interventions

Patients receive poly ICLC IM once weekly in weeks when no vaccine is given. Beginning 2 weeks after starting poly ICLC, patients receive personalized neo-antigen peptide vaccine IM once every 4 weeks and nivolumab every 2 or 4 weeks. Treatment continues for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients determined to have clinical benefit on a first course of treatment may repeat a 6 month course of treatment as described above. Patients then receive nivolumab every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA during screening as well as tumor biopsy, blood sample collection, and MRI, CT and/or PET throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Echocardiography

2013

Completed Phase 4

~11580

Biospecimen Collection

2004

Completed Phase 3

~2020

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2740

Multigated Acquisition Scan

2015

Completed Phase 3

~270

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Nivolumab

2015

Completed Phase 3

~4010

Poly ICLC

2014

Completed Phase 2

~270

0 / 25Eligibility 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, particularly advanced stages, often involve immunotherapy approaches that harness the body's immune system to target and destroy cancer cells. Treatments like the Personalized Neo-Antigen Peptide Vaccine work by inducing a polyclonal, poly-epitope, cytolytic T cell immunity against the tumor. This means they stimulate the patient's immune system to recognize and attack multiple specific antigens present on the melanoma cells, leading to a more robust and targeted immune response. This is crucial for melanoma patients as it can potentially lead to more effective and durable responses compared to traditional therapies, which may not be as specific or long-lasting.

Targeted therapy in renal cell carcinoma: moving from molecular agents to specific immunotherapy.