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Cancer Vaccine
NeoVax + CDX-301 + Nivolumab for Melanoma
Phase 1
Recruiting
Led By Patrick A Ott, MD, PhD
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 stage IIIB/C/D or stage IV cutaneous melanoma (mucosal melanoma or uveal melanoma are excluded) that is surgically resected, is deemed surgically resectable, or is unresectable; tumor tissue for sequence analysis must be available from either previous melanoma resection/biopsy or at least one site of disease must be amenable to surgical or core biopsy
Creatinine ≤ 1.5 x ULN OR Creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation
Awards & highlights
Study Summary
This trial is studying how well NeoVax works in combination with CDX-301 and Nivolumab in treating patients with melanoma.
Who is the study for?
Adults with stage IIIB/C/D or IV melanoma that's resectable or unresected, and not mucosal/uveal type. Must have good performance status, normal organ/marrow function, no severe allergies to study drugs, no HIV/AIDS or hepatitis B/C infection. Women must test negative for pregnancy and agree to contraception; men also need to use contraception.Check my eligibility
What is being tested?
The trial is testing a combination of NeoVax (a personalized cancer vaccine), CDX-301, and Nivolumab against melanoma. Participants will receive these drugs to see if they work better together in treating the disease compared to current standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine, flu-like symptoms such as fever and chills, fatigue, skin reactions like rash or itching. Nivolumab can cause immune-related issues affecting organs like lungs or intestines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is confirmed, operable or not, and tissue is available for testing.
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My kidney function is within the required range.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Dose Limiting Toxicity (DLT)
Recommended maximum tolerated dose (MTD)
Secondary outcome measures
Estimate rates of disease progression/recurrence depending on whether patient had all melanoma resected or has measurable disease per RECIST 1.1
Neoantigen-specific cellular immune responses
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: CDX-301 + Neovax + PembrolizumabExperimental Treatment3 Interventions
Participants will have vaccine made from tissue collected from tumor biopsy, or from previously collected archival biopsy or surgical tissue.
Participants will receive neoadjuvant Pembrolizumab for 3 doses every 3 weeks, then undergo standard-of-care surgical resection.
Participants will receive adjuvant NeoVax and CDX-301. CDX-301 will be administered at a predetermined dose, dependent on the number of participants previously enrolled, for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78.
Participants will receive adjuvant Pembrolizumab for 15 doses every 6 weeks.
Group II: CDX-301 + Neovax + NivolumabExperimental Treatment3 Interventions
Participants will have vaccine made from tissue collected from metastatic tumor biopsy or surgical resection, or from previously collected archival biopsy or surgical tissue.
Participants will receive Nivolumab at a flat dose every 4 weeks up to two years.
Participants will receive CDX-301 at a predetermined dose dependent on the number of participants previously enrolled for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
CDX-301
2017
Completed Phase 1
~170
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,950 Total Patients Enrolled
32 Trials studying Melanoma
2,880 Patients Enrolled for Melanoma
Celldex TherapeuticsIndustry Sponsor
61 Previous Clinical Trials
3,920 Total Patients Enrolled
8 Trials studying Melanoma
439 Patients Enrolled for Melanoma
Patrick A Ott, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease but it's either mild or under control.I am not breastfeeding if I decide to participate in this study.You have been diagnosed with HIV or AIDS.I agree to use contraception during and for 7 months after the study.I will use birth control or abstain from sex during and 5 months after the study.I have tested positive for hepatitis B or C.I am not pregnant or breastfeeding.My melanoma is confirmed, operable or not, and tissue is available for testing.Your bilirubin levels must be within a certain range, unless you have Gilbert Syndrome, in which case there is a different range.My kidney function, based on my age, weight, and creatinine levels, is suitable.My kidney function is within the required range.I am fully active or can carry out light work.I haven't had any vaccines (except for COVID-19) 4 weeks before or during my treatment.I have melanoma and haven't had anti-CTLA-4 therapy but stopped PD-1 inhibitors over 6 months ago.I had cancer before but have been cancer-free for 3 years or had certain types of cancer treated.Your white blood cell count is at least 3,000 per microliter.I am not planning any major surgery, except possibly for melanoma removal.I haven't taken any cancer drugs or immunosuppressants in the last 6 months.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am allergic to Nivolumab or CDX-301.My organ and bone marrow functions are normal.I have active cancer spread to my brain or its coverings.You have had a serious allergic reaction to any vaccine for preventing diseases.I do not have any ongoing serious illnesses or infections.I am 18 years old or older.I have recovered from previous cancer treatment side effects, except for hair loss or skin changes.I am a woman who can have children and have a negative pregnancy test before starting treatment.My cancer has Flt-3 mutations.You have a certain level of white blood cells.Your platelet count is at least 100,000 per microliter.Your liver enzymes (AST and ALT) must not be more than 3 times the upper limit of normal.Your hemoglobin level is higher than 9.0 grams per deciliter.My kidney function, based on my age, weight, and creatinine levels, is adequate.
Research Study Groups:
This trial has the following groups:- Group 1: CDX-301 + Neovax + Nivolumab
- Group 2: CDX-301 + Neovax + Pembrolizumab
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.
What is the participant count for this clinical research project?
"Affirmative. Indications present on clinicaltrials.gov demonstrate that this medical trial, whose postings first appeared on March 1st 2022 is presently enrolling participants. Specifically, the research project seeks to enlist 20 patients at two different sites."
Answered by AI
Is this endeavor a pioneering exploration?
"Presently, there are 717 active studies involving Nivolumab in 49 countries and 2356 cities. The first clinical trial sponsored by Ono Pharmaceutical Co. Ltd began way back 2012 with 659 participants; since then 254 more trials have been conducted and completed their Phase 1 & 2 drug approval stage."
Answered by AI
Are there still opportunities to participate in this experiment?
"Per clinicaltrials.gov, this trial is actively in search of study participants; the first posting was on January 3rd 2022 and most recently updated March 16th 2022."
Answered by AI
Are there any prior reports that have documented the use of Nivolumab?
"Presently, 717 different studies are being conducted to look into Nivolumab's efficacy. Of these trials, 82 have progressed to the third phase of clinical research. The majority of sites for this treatment are located in Basel, BE; though there exist 40290 other locations where medical professionals are running similar investigations."
Answered by AI
To what ailments is Nivolumab a common remedy?
"Nivolumab is typically prescribed to treat malignant neoplasms, but has also been found to help manage unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."
Answered by AI
Is Nivolumab a viable treatment option with minimal risk to the patient?
"Our Power team has assigned a rating of 1 to Nivolumab's safety on the basis that it is still in its early-stage trials and there is limited evidence validating its efficacy."
Answered by AI
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