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Cancer Vaccine for Melanoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 60 Patients • NCT02129075Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (poly ICLC, PNV21 vaccine, nivolumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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