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Cancer Vaccine

PD1 Inhibitor for Melanoma

Phase 2

Recruiting

Led By Igor Puzanov

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Have >= 1 tumor site amenable to core needle biopsy that is not the site of disease used to measure antitumor response

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a combination of a dendritic cell vaccine, interferon alpha-2, rintatolimod, and celecoxib to treat patients with HLA-A2 positive melanoma who have not responded to previous treatment.

Who is the study for?

This trial is for patients with HLA-A2 positive melanoma that hasn't improved after treatment, including anti PD-1/L1 therapy. They must have a tumor suitable for biopsy and measurable disease, be in fairly good health (ECOG 0-2), and meet specific blood test criteria. Pregnant women or those not using birth control are excluded, as well as individuals with certain heart conditions, active infections, known allergies to study drugs, recent transfusions or immunosuppressive treatments.Check my eligibility

What is being tested?

The trial tests a combination of therapies: polarized dendritic cell-based treatment (aDC1) to boost the immune system; interferon alpha-2 to enhance infection defense and slow cancer growth; rintatolimod possibly stimulating immunity; and celecoxib for pain relief. The goal is to see if this mix can stop melanoma from growing or progressing.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to immune stimulation such as flu-like symptoms from interferon alpha-2b (fever, chills), possible digestive issues due to celecoxib use like stomach pain or ulcers, allergic reactions if sensitive to any components used in the treatments, and general discomfort at injection sites.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that can be biopsied without affecting response measurement.

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I am able to get out of my bed or chair and move around.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I am HLA-A2 positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Durable objective response rate (>= 6 months)

ORR

Other outcome measures

Change in density of CD8 positive cytotoxic T cells

Change in density of molecular biomarkers

Immune-related progressive free survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (IFNA2, rintatolimod, celecoxib, alphaDC1 cell based treatment)Experimental Treatment6 Interventions

Patients receive recombinant interferon alpha-2 IV over 30 minutes, rintatolimod IV over 2.5 hours, and celecoxib PO BID on days 1-3. Beginning cycle 2, patients also receive alpha-type-1 polarized dendritic cells ID on day 1. Treatment repeats every 3 weeks up to 4 cycles in the absence of disease progression or unacceptable toxicity. At 12 weeks, patients with progressive disease may switch to ipilimumab with or without a PD-1/PD-L1 inhibitor and patients with a complete response CR, PR, or stable disease SD may switch to a PD-1/PD-L1 inhibitor or best alternative care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Recombinant Interferon Alfa-2b

2019

Completed Phase 2

~150

Celecoxib

2019

Completed Phase 4

~1740

Rintatolimod

2019

Completed Phase 2

~120

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,834 Total Patients Enrolled

10 Trials studying Melanoma

179 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,465 Total Patients Enrolled

557 Trials studying Melanoma

193,209 Patients Enrolled for Melanoma

Igor PuzanovPrincipal InvestigatorRoswell Park Cancer Institute

1 Previous Clinical Trials

39 Total Patients Enrolled

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 available for people to participate in this research study?

"According to current data hosted on clinicaltrials.gov, this study is searching for qualified applicants. The trial was initially posted on August 22nd 2022 and most recently updated the same day."

Answered by AI

What is the utmost capacity of enrollees in this trial?

"Affirmative. Clinicaltrials.gov attests to the fact that this clinical trial, which was first posted on August 22nd 2022, is actively searching for participants. 24 individuals need to be recruited from 1 medical centre in order to complete the study."

Answered by AI

What medical purpose does PD1 Inhibitor often serve?

"PD1 Inhibitor is a commonly prescribed remedy for osteoarthritis. It can additionally be used to counter anthracycline-based chemotherapy, HIV/AIDS and some forms of cancerous blood diseases."

Answered by AI

Has the FDA sanctioned PD1 Inhibitor for use in patients?

"Due to the Phase 2 nature of this trial, where there is some evidence that PD1 Inhibitor is safe but no proof it has therapeutic efficacy, our team at Power assigned a score of 2."

Answered by AI

Have prior investigations explored the implications of PD1 Inhibitor?

"Currently, 69 clinical trials for PD1 Inhibitor are underway. Of those, 16 have reached Phase 3 of testing. Buffalo is the epicentre of most studies related to this treatment, however 4595 sites across America offer access to these trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma

2024. "Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04093323.