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Poly ICLC for Cutaneous Melanoma

Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Cutaneous Melanoma+20 More ConditionsPoly ICLC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Clinical Stage III Cutaneous Melanoma
  • Locally Advanced Cutaneous Melanoma
  • Stage IV Cutaneous Melanoma
  • Unresectable Cutaneous Melanoma
  • Metastatic Conjunctival Melanoma
  • Metastatic Cutaneous Melanoma
  • Metastatic Acral Lentiginous Melanoma
  • Unresectable Mucosal Melanoma
  • Hormone Receptor-positive Breast Cancer
  • Metastatic HER2 Negative Breast Cancer
  • Metastatic Mucosal Melanoma
  • Recurrent Cutaneous Melanoma
  • Pathologic Stage III Cutaneous Melanoma
  • Stage IV Breast Cancer
  • Recurrent Acral Lentiginous Melanoma
  • Unresectable Acral Lentiginous Melanoma
  • Recurrent Mucosal Melanoma
  • Refractory HER2-Negative Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 year post first vaccination

Year 1
Best overall response
Incidence of adverse events
Progression-free survival
16 weeks
Biopsy
Year 1
Evaluation of target lesion
Week 48
Number of formulated and administered personalized neo-antigen vaccines
Number of formulated personalized neo-antigen vaccines with at least five (5) vaccine peptides

Trial Safety

Phase-Based Safety

1 of 3

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1
Echopulse
1
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1
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Side Effects for

Arm II (CDX-1401 and Poly-ICLC)
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%Pregnancy, puerperium and perinatal conditions
3%Ear and labyrinth disorders
3%Injury, poisoning and procedural complications
3%Immune system disorders
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02129075) in the Arm II (CDX-1401 and Poly-ICLC) ARM group. Side effects include: General disorders and administration site conditions with 100%, Nervous system disorders with 63%, Musculoskeletal and connective tissue disorders with 60%, Gastrointestinal disorders with 57%, Skin and subcutaneous tissue disorders with 47%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Treatment (poly ICLC, PNV21 vaccine, nivolumab)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Poly ICLC · No Placebo Group · Phase 1

Treatment (poly ICLC, PNV21 vaccine, nivolumab)Experimental Group · 3 Interventions: Nivolumab, Neoantigen Peptide Vaccine, Poly ICLC · Intervention Types: Biological, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Carboxymethylcellulose
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post first vaccination

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,242 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
538 Previous Clinical Trials
1,327,270 Total Patients Enrolled
Amazon.com Services LLCUNKNOWN
Joshua VeatchPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a current or past history of a serious lung condition called ILD/pneumonitis that required treatment with steroids.
You have melanoma and have already received the recommended treatment for your stage of the disease according to NCCN guidelines. Your disease has returned or has not responded to at least one previous treatment.
You have had the standard treatment for your stage of breast cancer as per NCCN guidelines and your cancer has returned or has not responded to at least one prior treatment.
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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