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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
Female and/or male patients age >= 18 years
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
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 below
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I am 18 years old or older.
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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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I am 60 or older and had a heart function test in the last 2 months.
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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 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

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 more

Side effects data

From 2018 Phase 2 trial • 60 Patients • NCT02129075
100%
General disorders and administration site conditions
63%
Nervous system disorders
60%
Musculoskeletal and connective tissue disorders
57%
Gastrointestinal disorders
47%
Skin and subcutaneous tissue disorders
47%
Investigations
43%
Respiratory, thoracic and mediastinal disorders
40%
Metabolism and nutrition disorders
33%
Blood and lymphatic system disorders
30%
Infections and infestations
20%
Vascular disorders
13%
Psychiatric disorders
10%
Renal and urinary disorders
10%
Eye disorders
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
7%
Cardiac disorders
7%
Surgical and medical procedures
7%
Reproductive system and breast disorders
3%
Immune system disorders
3%
Pregnancy, puerperium and perinatal conditions
3%
Ear and labyrinth disorders
3%
Injury, poisoning and procedural complications
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (CDX-1401 and Poly-ICLC)
Arm I (CDX-301, 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

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,225 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,195 Total Patients Enrolled
Amazon.com Services LLCUNKNOWN
1 Previous Clinical Trials
2,000 Total Patients Enrolled

Media Library

Neoantigen Peptide Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05098210 — Phase 1
Cutaneous Melanoma Research Study Groups: Treatment (poly ICLC, PNV21 vaccine, nivolumab)
Cutaneous Melanoma Clinical Trial 2023: Neoantigen Peptide Vaccine Highlights & Side Effects. Trial Name: NCT05098210 — Phase 1
Neoantigen Peptide Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098210 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this clinical experiment?

"Per the records on clinicaltrials.gov this research trial is presently seeking participants. The study was originally posted to the website on June 9th 2022 and has since been amended as of September 7th 2022."

Answered by AI

Has the given dosage and formulation of Poly ICLC been approved by the Food and Drug Administration?

"Our team at Power rated Poly ICLC's safety as a 1 due to the limited efficacy and safety data available, consistent with Phase 1 trials."

Answered by AI

What research has been conducted related to Poly ICLC?

"Currently, the total number of active research studies for Poly ICLC stands at 729 with 83 in Phase 3. While most trials are located in Basel, BE; there exist 40335 medical centres running tests on this substance."

Answered by AI

What medical indications is Poly ICLC commonly utilized to address?

"Poly ICLC is an approved treatment for metastatic gastric adenocarcinoma, renal cell carcinoma and those who have undergone complete resection."

Answered by AI

What is the cap on the amount of participants engaging in this trial?

"Affirmative. The information on clinicaltrials.gov indicates that the trial is currently engaging in patient recruitment efforts, with its original post date of June 9th 2022 and most recent edit occurring on September 7th 2022. A total of 20 individuals are needed from a single medical site."

Answered by AI

Does this clinical trial represent an unprecedented attempt?

"Presently, 2358 cities across 49 nations host 729 active studies that feature Poly ICLC. These trials commenced in 2007 when Baxter Healthcare Corporation initiated a Phase 4 drug approval process with 4640 patients and has since completed 312 separate investigations."

Answered by AI
~5 spots leftby Nov 2024