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Cancer Vaccine

Neoadjuvant Daromun + Surgery for Melanoma (NeoDREAM Trial)

Phase 3

Recruiting

Led By Jonathan S Zager, MD FACS

Research Sponsored by Philogen S.p.A.

Eligibility Criteria Checklist

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

Must have

Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm

All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above

Must not have

Evidence of distant metastases at screening

Ischemic peripheral vascular disease (Grade IIb-IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first, assessed up to 72 months.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial hopes to find that Daromun, a neoadjuvant treatment, followed by surgery and adjuvant therapy, will improve the recurrence-free survival of Stage IIIB/C melanoma patients.

Who is the study for?

This trial is for adults over 18 with Stage IIIB/C melanoma that can be surgically removed. They must have a life expectancy over 24 months, good performance status, and normal organ function tests. Women of childbearing age must test negative for pregnancy and use effective contraception. Exclusions include other cancer types, uncontrolled diseases, recent major trauma or surgery, breastfeeding women, certain drug treatments within specific timeframes before enrollment.

What is being tested?

The study is testing the effectiveness of Daromun as a pre-surgery (neoadjuvant) treatment followed by surgery and additional therapy to see if it helps patients with Stage IIIB/C melanoma live longer without their cancer returning compared to just having surgery and additional therapy.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include typical reactions to immunotherapy such as flu-like symptoms, fatigue, skin reactions at injection sites, allergic responses or more serious immune-related adverse events.

Eligibility Criteria

Inclusion Criteria

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

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I have melanoma that can be measured and treated by injection.

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All side effects from my previous treatments, except for hair loss, are mild or gone.

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I have stage IIIB or IIIC melanoma that can be completely removed by surgery.

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I can carry out all my usual activities without help.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body.

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I have severe blockages in my arteries.

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I have severe damage to my retina due to diabetes.

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I have had an organ or stem cell transplant.

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My cancer is either in the eye (uveal melanoma) or in the mucous membranes (mucosal melanoma).

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My blood pressure is not controlled by medication.

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I will not receive growth factors or immune-boosting drugs within a week before joining.

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I am currently breastfeeding.

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My heart condition is not severe (not worse than NYHA Grade II).

Select...

My heart rhythm problem is not well controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first, assessed up to 72 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first, assessed up to 72 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first, assessed up to 72 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recurrence Free Survival (RFS)

Secondary study objectives

Adverse Events (AE)

Adverse Events of Special Interest (AESI)

Concomitant medication

+8 more

Other study objectives

Distant metastasis-free survival (DMFS)

Local recurrence-free survival (LRFS)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Daromun plus Surgery and Adjuvant therapy (Arm 1)Experimental Treatment3 Interventions

Two-weeks screening period and a 4-weeks open-label treatment period, followed by surgery within a maximum of another 4 weeks and adjuvant therapy (Arm 1).

Group II: Surgery and adjuvant therapy (Arm 2)Active Control2 Interventions

Patients in the control arm (Arm 2) will receive direct surgery within 4 weeks from randomization, followed by adjuvant therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adjuvant therapy

2002

Completed Phase 3

~430

Surgery

2000