All > Melanoma

Nivolumab for Melanoma

Brigham and Women's Hospital, Boston, MA
Melanoma+1 More ConditionsNivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well NeoVax works in combination with CDX-301 and Nivolumab in treating patients with melanoma.

Eligible Conditions
  • Metastatic Melanoma
  • Melanoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
Nivolumab
1
Nivolumab
1
CG0070

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Toxicities experienced within 49 days/7 weeks of Neoantigen Vaccine treatment initiation

Week 24
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
Week 7
Rate of Dose Limiting Toxicity (DLT)
Week 12
Recommended maximum tolerated dose (MTD)
Week 24
Anti-tumor activity at Week 24
Response conversion rate (RCR) at Week 24

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Nivolumab
1
Nivolumab
1
CG0070

Side Effects for

Investigator Choice of Chemotherapy
57%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%Neutropenia
21%Pyrexia
19%Hypomagnesaemia
19%Headache
18%Arthralgia
16%Asthenia
16%Dizziness
16%Neutrophil count decreased
15%Thrombocytopenia
15%Insomnia
14%Weight decreased
14%Hyponatraemia
14%Rash
14%Platelet count decreased
13%Blood creatinine increased
13%White blood cell count decreased
12%Pain in extremity
12%Pruritus
12%Hypokalaemia
12%Abdominal pain
11%Alanine aminotransferase increased
11%Aspartate aminotransferase increased
11%Myalgia
10%Pneumonia
10%Muscular weakness
10%Productive cough
10%Alopecia
10%Dry skin
10%Chest pain
10%Hypoalbuminaemia
10%Dysgeusia
9%Abdominal pain upper
9%Mucosal inflammation
9%Hypothyroidism
9%Upper respiratory tract infection
9%Peripheral sensory neuropathy
8%Lacrimation increased
8%Non-cardiac chest pain
8%Nasopharyngitis
8%Dysphonia
8%Epistaxis
8%Haemoptysis
8%Stomatitis
7%Anxiety
7%Bronchitis
7%Hypertension
7%Hyperkalaemia
7%Dehydration
7%Chills
7%Blood alkaline phosphatase increased
7%Hyperglycaemia
7%Lymphocyte count decreased
6%Oropharyngeal pain
6%Pneumonitis
6%Pleural effusion
6%Neuropathy peripheral
6%Hypophosphataemia
6%Leukopenia
5%Hypotension
5%Urinary tract infection
5%Dry mouth
5%Muscle spasms
5%Pain
5%Gamma-glutamyltransferase increased
5%Malaise
5%Depression
5%Rash maculo-papular
5%Dyspepsia
5%Musculoskeletal chest pain
4%Fall
4%Pulmonary embolism
3%Myocardial infarction
3%Metastases to central nervous system
3%Musculoskeletal pain
3%Chronic obstructive pulmonary disease
3%Febrile neutropenia
2%Adrenal insufficiency
2%Atrial fibrillation
2%Sepsis
2%Malignant pleural effusion
2%Embolism
2%Cardiac failure
2%General physical health deterioration
1%Pancytopenia
1%Lung cancer metastatic
1%Small intestinal haemorrhage
1%Neoplasm progression
1%Gastrointestinal haemorrhage
1%Colitis
1%Appendicitis
1%Respiratory tract infection
1%Bone pain
1%Ataxia
1%Syncope
1%Bronchial obstruction
1%Pneumothorax
1%Circulatory collapse
1%Superior vena cava syndrome
1%Respiratory failure
1%Seizure
1%Atrial flutter
1%Pericardial effusion
1%Ileus
1%Small intestinal obstruction
1%Performance status decreased
1%Skin infection
1%Femur fracture
1%Hypercalcaemia
1%Cancer pain
1%Pericardial effusion malignant
1%Confusional state
1%Tumour pain
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the Investigator Choice of Chemotherapy ARM group. Side effects include: Nausea with 57%, Anaemia with 54%, Fatigue with 51%, Decreased appetite with 39%, Malignant neoplasm progression with 36%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

CDX-301 + Neovax + Nivolumab
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 1

CDX-301 + Neovax + NivolumabExperimental Group · 3 Interventions: CDX-301, NEOVAX, Nivolumab · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-301
2017
Completed Phase 1
~170
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation

Who is running the clinical trial?

Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,852 Total Patients Enrolled
8 Trials studying Melanoma
436 Patients Enrolled for Melanoma
Dana-Farber Cancer InstituteLead Sponsor
1,029 Previous Clinical Trials
755,789 Total Patients Enrolled
30 Trials studying Melanoma
2,920 Patients Enrolled for Melanoma
Patrick A Ott, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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