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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
Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg, and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV negative serum HBV-DNA is also required
Males or females, age ≥ 18 years
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

NeoDREAM 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.Check my eligibility
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.See study design
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.

NeoDREAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tested negative for HIV, Hepatitis B, and Hepatitis C.
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I am 18 years old or older.
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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 am not pregnant, will use effective birth control, and agree to pregnancy tests.
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I agree to use two forms of birth control with my partner until three months after my last treatment.
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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.
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I am willing and able to follow the study's schedule and procedures.

NeoDREAM Trial 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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence Free Survival (RFS)
Secondary outcome measures
Adverse Events (AE)
Adverse Events of Special Interest (AESI)
Concomitant medication
+12 more
Other outcome measures
Distant metastasis-free survival (DMFS)
Local recurrence-free survival (LRFS)

NeoDREAM 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
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Philogen S.p.A.Lead Sponsor
37 Previous Clinical Trials
2,088 Total Patients Enrolled
8 Trials studying Melanoma
687 Patients Enrolled for Melanoma
Jonathan S Zager, MD FACSPrincipal InvestigatorMoffitt Cancer Center

Media Library

Daromun (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03567889 — Phase 3
Melanoma Research Study Groups: Daromun plus Surgery and Adjuvant therapy (Arm 1), Surgery and adjuvant therapy (Arm 2)
Melanoma Clinical Trial 2023: Daromun Highlights & Side Effects. Trial Name: NCT03567889 — Phase 3
Daromun (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03567889 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are enrolled in this clinical trial?

"That is correct. The clinicaltrials.gov website provides updated information about this trial, which began enrolling patients on 9/20/2018. As of 10/21/2022, there are 186 enrollees from 12 different sites."

Answered by AI

Are new participants currently being accepted for this experiment?

"That is correct. The listing on clinicaltrials.gov says that the study is currently looking for volunteers. The trial was first advertised on September 20th, 2018 and has since been updated October 21st, 2022. A total of 186 people are needed to enroll at 12 different sites."

Answered by AI

What are the government's thoughts on using Adjuvant therapy?

"Adjuvant therapy has been shown to be effective in multiple trials, so it receives a score of 3."

Answered by AI

Could you please summarize how many locations are conducting this experiment?

"There are presently 12 sites where this trial is being conducted. Some of the locations include Columbus, Hershey and La Jolla. If you choose to enroll in this study, please try and select the nearest site to reduce travel requirements."

Answered by AI
~5 spots leftby Jun 2024