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NCT03567889RECRUITINGIRB Ready

Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients

(NeoDREAM)

Sponsored by Philogen S.p.A.

Quick Self-Assessment

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1 of 186 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

Who Can Participate

Inclusion Criteria

Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable). 2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (โ‰ฅ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of โ‰ฅ 10 mm. 3. Males or females, age โ‰ฅ 18 years. 4. ECOG Performance Status/WHO Performance Status โ‰ค 1. 5. Life expectancy of \> 24 months. 6. Absolute neutrophil count \> 1.5 x 109/L. 7. Hemoglobin \> 9.0 g/dL. 8. Platelets \> 100 x 109/L. 9. Total bilirubin โ‰ค 30 ยตmol/L (or โ‰ค 2.0 mg/dl). 10. ALT and AST โ‰ค 2.5 x the upper limit of normal (ULN). 11. Serum creatinine \< 1.5 x ULN . 12. LDH serum level โ‰ค 1.5 x ULN. 13. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg, and anti-HBcAg Ab is

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

186 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Philogen S.p.A.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
ACTIVE_NOT_RECRUITING

La Jolla

California

Location available
View La Jolla location page
ACTIVE_NOT_RECRUITING

Orange

California

Location available
View Orange location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
ACTIVE_NOT_RECRUITING

Chicago

Illinois

Location available
View Chicago location page
ACTIVE_NOT_RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
RECRUITING

New Brunswick

New Jersey

Location available
View New Brunswick location page

๐Ÿ“ And 10 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Melanoma Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Melanoma Treatment Options in Phoenix, Arizona

If you're searching for Melanoma treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, La Jolla, Orange and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Melanoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 186 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Melanoma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Melanoma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Melanoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03567889. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.