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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post first vaccination
Awards & highlights
Study Summary
This trial is testing a personalized cancer vaccine to see if it is safe and can help patients with metastatic melanoma or breast cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Best overall response
Evaluation of target lesion
Number of formulated and administered personalized neo-antigen vaccines
+3 moreSide effects data
From 2018 Phase 2 trial • 60 Patients • NCT02129075100%
General disorders and administration site conditions
67%
Musculoskeletal and connective tissue disorders
57%
Nervous system disorders
50%
Metabolism and nutrition disorders
50%
Gastrointestinal disorders
50%
Skin and subcutaneous tissue 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%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10%
Ear and labyrinth disorders
7%
Renal and urinary disorders
7%
Surgical and medical procedures
3%
Reproductive system and breast disorders
3%
Cardiac disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (CDX-301, CDX-1401, and Poly-ICLC)
Arm II (CDX-1401 and Poly-ICLC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (poly ICLC, PNV21 vaccine, nivolumab)Experimental Treatment3 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 continuous for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Poly ICLC
2014
Completed Phase 2
~270
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.
Targeted therapy in renal cell carcinoma: moving from molecular agents to specific immunotherapy.
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,306 Total Patients Enrolled
14 Trials studying Melanoma
819 Patients Enrolled for Melanoma
Fred Hutchinson Cancer CenterLead Sponsor
558 Previous Clinical Trials
1,345,562 Total Patients Enrolled
14 Trials studying Melanoma
819 Patients Enrolled for Melanoma
Amazon.com Services LLCUNKNOWN
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is 9 mg/dL or higher.I am currently breastfeeding or plan to during the study.I haven't taken any immune-weakening drugs in the last 2 weeks.We don't know how a neoantigen vaccination might affect a growing baby inside a pregnant woman.I currently have a fever due to an infection.I am 18 years old or older.My autoimmune disease has been uncontrolled for the last year despite treatment.You have had a bone marrow or solid organ transplant in the past.I have recovered from previous cancer treatment side effects to a mild level.I can take care of myself and am up and about more than half of my waking hours.My blood clotting tests are normal or I'm on blood thinners.I do not have, nor have I had, lung conditions needing steroid treatment.I know my melanoma's BRAF mutation status.I currently have an infection that isn't under control.I have breast cancer with symptoms due to lung, bone marrow, or liver spread.You must have at least 50,000 platelets per microliter of blood.I have had a severe immune reaction to cancer immunotherapy, except for manageable hormone issues or silent enzyme increases.I have not received a live vaccine in the last 30 days.Your absolute neutrophil count is greater than 1000 cells per cubic millimeter.My liver function tests are within the required range.You have a positive test for HIV.My melanoma is specifically in the eye (uveal or choroidal).I have a known immune system deficiency.I am 60 or older and had a heart function test in the last 2 months.If you could have a baby, you need to have a negative pregnancy test before joining the study.I have pain from my cancer that isn't relieved by treatment.My kidney function is normal, with creatine below 1.5 mg/dL or eGFR above 60 mL/min.I have mild or no shortness of breath and my oxygen levels are above 92% without extra oxygen.I have breast cancer that came back or didn't go away after treatment.I have a tumor or tumors that can be biopsied or removed.Your disease can be measured using specific guidelines called RECIST 1.1.I have melanoma and it came back after I received the standard treatment.I agree to use two effective birth control methods during and 5 months after the study.I have brain metastases that cause symptoms.I need frequent drainage for fluid buildup in my chest or abdomen more than once a month.I have ongoing side effects from previous immune therapy, except for stable hormone issues or vitiligo.My cancer is spreading quickly and causing symptoms.I stopped a PD-1 inhibitor treatment due to a severe immune-related side effect.My melanoma diagnosis was confirmed with a tissue test.I have not had serious heart issues or uncontrolled infections recently.My breast cancer is hormone receptor positive and HER2 negative.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (poly ICLC, PNV21 vaccine, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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