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Cancer Vaccine

Combination Therapy 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

Must not have

Has a history of cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia (within 3 months of signing consent) or, subject has a New York Heart Association classification of III or IV

Women of child bearing potential who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a recent heart problem or my heart condition severely limits my activities.

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I am pregnant or nursing.

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I have an active hepatitis B or C infection.

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My cancer stopped responding to initial PD1 blocker treatment.

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I am currently being treated for an infection.

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I have another cancer that is getting worse or needs treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Durable objective response rate (>= 6 months)

ORR

Other study objectives

Change in density of CD8 positive cytotoxic T cells

Change in density of molecular biomarkers

Immune-related progressive free survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Celecoxib

2019

Completed Phase 4

~1740

Rintatolimod

2019

Completed Phase 2

~120