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Checkpoint Inhibitor
NeoVax + Immunotherapy for Melanoma
Phase 1
Waitlist Available
Led By Patrick A Ott, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically confirmed melanoma that is unresectable stage III or stage IV; at least one site of disease must be resectable, partially-resectable, or amenable to core biopsies to provide tumor tissue for sequence analysis
ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is testing a new type of vaccine, NeoVax, in combination with other drugs to see if it can treat melanoma.
Who is the study for?
Adults over 18 with advanced melanoma that can't be removed by surgery or is stage III/IV. They must have normal organ/marrow function, no HIV/AIDS, and not be pregnant/nursing. Participants should agree to use contraception and have recovered from previous treatments.Check my eligibility
What is being tested?
The trial tests a personalized neoantigen vaccine (NeoVax) plus Montanide with Ipilimumab (Yervoy) and Nivolumab (Opdivo). It aims to see if this combination helps treat unresectable or stage III/IV melanoma more effectively than current methods.See study design
What are the potential side effects?
Possible side effects include immune system reactions like inflammation in organs, allergic responses to the vaccines, fatigue, skin changes such as alopecia or vitiligo, digestive issues, blood-related problems, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma cannot be fully removed by surgery but a part can be biopsied.
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I am fully active or can carry out light work.
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My blood tests show normal organ function and I don't have severe anemia or liver/kidney issues.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am not breastfeeding if I start treatment with Ipilimumab, Nivolumab, and a personalized vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of DLT
Secondary outcome measures
Assess the induction of IFN-γ T-cell response or tetramer staining to the assay peptides
Rate of complete responses
Rate of objective responses
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab+Ipilimumab+NeoVax plus MontanideExperimental Treatment3 Interventions
Run in period will begin within 2 weeks of metastatic tissue biopsy, once the following criteria
Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days)
Patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21
Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,928 Total Patients Enrolled
32 Trials studying Melanoma
2,890 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
557 Trials studying Melanoma
193,213 Patients Enrolled for Melanoma
Patrick A Ott, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unmanaged ongoing illnesses.Women who could become pregnant should have a negative pregnancy test within 24 hours before starting Nivolumab.I haven't taken steroids or immune-weakening drugs in the last 2 weeks.I agree to use birth control from the start of the study until 31 weeks after the last dose.I have not received vaccines for infectious diseases in the last 4 weeks.My melanoma cannot be fully removed by surgery but a part can be biopsied.I am fully active or can carry out light work.I haven't taken any cancer or immunosuppressive drugs in the last 6 months.My blood tests show normal organ function and I don't have severe anemia or liver/kidney issues.I am scheduled for a major surgery soon.I am 18 years old or older.My cancer can be measured and hasn't been locally treated in the last year.I am fully active or restricted in physically strenuous activity but can do light work.I have recovered from previous cancer treatment side effects, except for hair loss or skin color changes.I am not breastfeeding if I start treatment with Ipilimumab, Nivolumab, and a personalized vaccine.I will use birth control or abstain from sex during and for 23 weeks after the study.I have active cancer spread to my brain or its coverings.You had a serious allergic reaction to any vaccine for preventing diseases.You have a positive test for hepatitis B or C virus, showing that you have an ongoing infection.I have not had cancer before, or if I did, it was under certain conditions.I have an autoimmune disease.I have received immunotherapy for melanoma, but not anti-CTLA-4.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Ipilimumab+NeoVax plus Montanide
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment presently recruiting participants?
"As per the publicly available information on clinicaltrials.gov, this research is in need of volunteers as of 11/15/2022. The original post-date for the trial was 11/11/2020."
Answered by AI
Are there any precedential research projects that have looked into the combination of NeoVax and Montanide?
"Presently, there are 764 experiments involving NeoVax plus Montanide in progress. Of these ongoing trials, 86 have achieved Phase 3 status. These studies originated from Pittsburgh Pennsylvania but have now been expanded to 42751 medical sites across the country."
Answered by AI
How has NeoVax plus Montanide been employed to benefit patients?
"NeoVax plus Montanide is a common therapy for anti-angiogenic treatments. This combination can also be used to treat various other conditions, such as malignant neoplasms, unresectable melanoma and squamous cell carcinoma."
Answered by AI
Has the combination of NeoVax and Montanide been officially sanctioned by the FDA?
"Limited clinical data exists regarding the safety and efficacy of NeoVax plus Montanide, thus it has been assigned a score of 1."
Answered by AI
To what extent is the experimental sample size in this research study?
"Affirmative. Per data hosted on clinicaltrials.gov, this medical investigation is in the process of recruiting participants since its posting date of November 11th 2020 and most recently edited yesterday - 15/11/2022. To fulfill their requirements, they need to enroll 20 patients at 1 site."
Answered by AI
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