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Cancer Vaccine
Cancer Vaccine +/− CDX-1127 for Melanoma (Mel-65 Trial)
Phase 1 & 2
Waitlist Available
Led By Craig L Slingluff, Jr., MD
Research Sponsored by Craig L Slingluff, Jr
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1
Age 18 years or older at registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020)
Awards & highlights
Mel-65 Trial Summary
This trial is testing a new cancer vaccine with two different adjuvants to see if it is safe and if it boosts the immune response to the vaccine.
Who is the study for?
This trial is for adults over 18 with stage II-IV melanoma, who are currently free of disease post-treatment or surgery. They must have good performance status and organ function, not be pregnant or breastfeeding, and without a history of certain autoimmune disorders or recent treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests the safety and immune response to a peptide vaccine (6MHP) combined with adjuvants Montanide ISA-51 and polyICLC, plus CDX-1127 monoclonal antibody in some participants. It's evaluating if these substances can boost the body's defense against melanoma when given together.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever or fatigue, allergic responses to vaccine components, and possible immune-related effects due to CDX-1127.
Mel-65 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are in good enough physical condition to perform daily activities without help or with a little help.
Select...
You may have had different types of melanoma, but it needs to be confirmed by a specific type of examination. If you have cutaneous melanoma, it will be staged using a specific system.
Mel-65 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 22 and day 85 (note: day 85 biopsy not required for participants whose day 85 visit would be due after irb approval of protocol v12-03-2020)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunogenicity-Percent of patients with persistent CD4+ T cell responses to the 6MHP vaccine
Safety of CDX-1127 administered with a melanoma vaccine
Secondary outcome measures
Immunogenicity - Frequency of circulating CD4+ Th1 responses
Immunogenicity-Frequency of CD4+ Th1 memory responses
Immunogenicity-Frequency of durable CD4+ Th1 memory responses
+2 moreSide effects data
From 2020 Phase 1 & 2 trial • 22 Patients • NCT02515227100%
Injection site reaction
83%
Skin induration
67%
Fatigue
50%
Fever
50%
Pruritis
50%
Rash maculo-papular
33%
Arthralgia
33%
Myalgia
33%
Lymphocyte count decreased
33%
Bruising
17%
Anemia
17%
Chills
17%
Flu-like symptoms
17%
Aspartate aminotransferase increased
17%
Hyperuricemia
17%
Headache
17%
Allergic rhinitis
17%
Dyspnea
17%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
6MHP + Pembrolizumab (PD-1 Antibody-naive Cohort)
6MHP + Pembrolizumab (PD-1 Antibody-experienced Cohort)
Mel-65 Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: 6MHP/Montanide ISA-51 + polyICLCExperimental Treatment3 Interventions
200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176.
Group II: Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127Experimental Treatment4 Interventions
200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176. CDX-1127 (3mg/kg) will be administered intravenously on days 1, 36, and 78.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-1127
2011
Completed Phase 2
~130
6MHP
2016
Completed Phase 2
~100
Montanide ISA-51
1999
Completed Phase 2
~340
polyICLC
2018
Completed Phase 2
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for melanoma, such as immune checkpoint inhibitors (e.g., nivolumab and ipilimumab) and peptide vaccines, work by enhancing the body's immune response against cancer cells. Immune checkpoint inhibitors block proteins that prevent T-cells from attacking cancer cells, thereby boosting the immune system's ability to target and destroy melanoma cells.
Peptide vaccines, like the 6MHP with adjuvants, introduce specific antigens to the immune system, prompting it to recognize and attack melanoma cells more effectively. The addition of adjuvants and monoclonal antibodies like CDX-1127 further amplifies this immune response.
These mechanisms are crucial for melanoma patients as they can lead to more effective and durable responses against the cancer, potentially improving survival rates and quality of life.
A Bayesian network meta-analysis of comparison of cancer therapeutic vaccines for melanoma.
A Bayesian network meta-analysis of comparison of cancer therapeutic vaccines for melanoma.
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Who is running the clinical trial?
Craig L Slingluff, JrLead Sponsor
23 Previous Clinical Trials
713 Total Patients Enrolled
18 Trials studying Melanoma
608 Patients Enrolled for Melanoma
Celldex TherapeuticsIndustry Sponsor
61 Previous Clinical Trials
3,917 Total Patients Enrolled
8 Trials studying Melanoma
436 Patients Enrolled for Melanoma
Craig L Slingluff, Jr., MD3.04 ReviewsPrincipal Investigator - University of Virginia
University of Virginia
2 Previous Clinical Trials
124 Total Patients Enrolled
2 Trials studying Melanoma
124 Patients Enrolled for Melanoma
5Patient Review
Dr Slingluff is a hero in my eyes. They saved my wife's life and were incredibly professional throughout the whole ordeal.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received certain medications or treatments within a specific time period before joining the study, such as chemotherapy or radiation therapy.You have received treatment with CDX-1127 or a similar type of medication before.You may have had different types of melanoma, but it needs to be confirmed by a specific type of examination. If you have cutaneous melanoma, it will be staged using a specific system.You have allergies to any part of the vaccine.You have a known addiction to alcohol or drugs and are currently using them, or have used illicit IV drugs in the past year.You have a history of serious autoimmune disorders that required strong medication to treat.You are in good enough physical condition to perform daily activities without help or with a little help.You have received the 6MHP vaccine before.You have been diagnosed with advanced stage melanoma within the last 6 months.You have HIV or active Hepatitis C.Your diabetes is not well managed, with an HgbA1c level higher than 8.5%.You weigh less than 110 pounds because a lot of blood will need to be drawn for the study.You have had lung inflammation caused by an autoimmune condition before.People with small, uncertain findings on their scans or during their check-ups may be allowed to participate.If you have stage IIA melanoma as determined by the DecisionDx Melanoma test, you may be eligible.You have severe heart disease classified as Class III or IV by the New York Heart Association.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127
- Group 2: Arm B: 6MHP/Montanide ISA-51 + polyICLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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