← Back to Search

AV-MEL-1 + Anti-PD-1 for Melanoma

Phase 1
Recruiting
Research Sponsored by Aivita Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of at least one metastatic lesion that is to be removed surgically as part of standard care (e.g. diagnosis or diagnostic testing, mono- or oligometastatic disease, alleviation of symptoms etc)
Diagnosis of metastatic melanoma with at least one lesion that is amenable for surgical resection per standard of care (e.g. diagnosis or diagnostic testing, mono- or oligometastatic disease, alleviation of symptoms etc)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new combination therapy for metastatic melanoma. The therapy consists of anti-PD1 monoclonal antibodies and AV-MEL-1. The study is open to patients who have never received treatment for metastatic melanoma or who have been previously treated with anti-PD-1 or with inhibitors of the BRAF/MEK pathway. The trial will enroll 14 to 20 patients.

Who is the study for?
This trial is for adults over 18 with metastatic melanoma, who are fit enough to undergo surgery for at least one lesion and can start anti-PD-1 therapy. They should have a good performance status (able to care for themselves) and not be on any investigational drugs or have serious heart disease, uncontrolled brain metastases, active hepatitis B/C or HIV, another life-threatening cancer, severe infections, bleeding disorders, autoimmune diseases or need immunosuppressive therapy.Check my eligibility
What is being tested?
The study tests the safety of AV-MEL-1 combined with anti-PD-1 antibodies in patients with metastatic melanoma. It's an open-label phase IB trial aiming to treat 14-20 patients. Participants may be new to treatment or previously treated with specific inhibitors due to BRAF600E/K mutations.See study design
What are the potential side effects?
Potential side effects include those commonly associated with immune therapies such as inflammation in various organs (like colitis), fatigue, skin reactions (rash), hormonal gland issues (thyroid problems), and possibly infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a cancer spread that will be surgically removed.
Select...
I have metastatic melanoma with at least one tumor that can be surgically removed.
Select...
I am mostly independent and can care for myself.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Primary Safety Endpoint: Number of grade 3-5 adverse events with AV-MEL-1 + PD-1 versus PD-1 alone

Trial Design

1Treatment groups
Experimental Treatment
Group I: AV-MEL-1Experimental Treatment1 Intervention
AV-MEL-1: Autologous dendritic cells loaded with autologous tumor antigens (ATA) from a short-term cell culture of autologous tumor cells. AV-MEL-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.

Find a Location

Who is running the clinical trial?

Aivita Biomedical, Inc.Lead Sponsor
7 Previous Clinical Trials
1,025 Total Patients Enrolled
Robert O Dillman, MDStudy ChairAivita Biomedical, Inc.
7 Previous Clinical Trials
913 Total Patients Enrolled
2 Trials studying Melanoma
60 Patients Enrolled for Melanoma

Media Library

AV-MEL-1 Clinical Trial Eligibility Overview. Trial Name: NCT03743298 — Phase 1
Melanoma Research Study Groups: AV-MEL-1
Melanoma Clinical Trial 2023: AV-MEL-1 Highlights & Side Effects. Trial Name: NCT03743298 — Phase 1
AV-MEL-1 2023 Treatment Timeline for Medical Study. Trial Name: NCT03743298 — Phase 1

Frequently Asked Questions

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

Is enrollment for this trial still open?

"It appears that this medical trial is actively enrolling patients, as per the information on clinicaltrials.gov. The clinical study was first advertised to the public on April 21st 2021 and has undergone modifications since then with its most recent update being done in December 14th 2021."

Answered by AI

How many participants is this experiment accommodating?

"Affirmative. The information on clinicaltrials.gov confirms that this experiment is currently recruiting individuals, with the first posting taking place April 21st 2021 and a recent update occurring December 14th 2021. To complete the study, 20 people need to be recruited from two separate sites."

Answered by AI

Has AV-MEL-1 received clearance from the FDA?

"With limited data on both efficacy and safety, AV-MEL-1 was assigned a score of 1 by Power's team."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma
2021. "Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03743298.
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top