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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has no prior systemic treatment for advanced disease
Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on week 1 (baseline), weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and week 105
Awards & highlights
Study Summary
This trial will compare two treatments for people with untreated, advanced skin cancer to see which works better and is safer.
Who is the study for?
This trial is for adults with melanoma that can't be surgically removed or has spread, who haven't had systemic treatment for advanced disease. They must have measurable disease and be in good physical condition (ECOG 0 or 1). People with a history of certain immune treatments, active brain metastases, ocular melanoma, severe allergies to monoclonal antibodies, or those on immunosuppressants can't participate.Check my eligibility
What is being tested?
The study compares ABP 206 with Nivolumab in patients who've never been treated for unresectable or metastatic melanoma before. It aims to evaluate how well these drugs work, their safety profiles, and the body's immune response to them.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs like lungs and intestines; skin issues; hormonal gland problems; fatigue; infusion-related reactions; and possibly others based on individual responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any systemic treatment for my advanced disease.
Select...
My tumor tissue from surgery is available for testing.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My melanoma cannot be removed by surgery and may have spread.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on week 1 (baseline), weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and week 105
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on week 1 (baseline), weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and week 105
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of response (DOR)
Objective response at Week 17
Objective response by Week 49
+2 moreSecondary outcome measures
Number of subjects with anti-drug antibodies
Number of subjects with treatment-emergent adverse events
Number of subjects with treatment-emergent adverse events of interest
+2 moreSide 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%
Sepsis
2%
Malignant pleural effusion
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
Active Control
Group I: ABP 206Experimental Treatment1 Intervention
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Group II: NivolumabActive Control1 Intervention
Subjects will receive Dose A of Nivolumab via IV infusion.
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,598 Total Patients Enrolled
23 Trials studying Melanoma
18,886 Patients Enrolled for Melanoma
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,110 Total Patients Enrolled
13 Trials studying Melanoma
2,359 Patients Enrolled for Melanoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ABP 206 been granted regulatory approval by the FDA?
"Our team has ranked the safety of ABP 206 as a 3, due to prior evidence supporting its efficacy and multiple clinical trials affirming its security."
Answered by AI
What criteria must be met to participate in this medical research?
"Enrollees for this study must be between the age of 18 and 99, with a diagnosis of melanoma. A total number of 620 individuals are needed to partake in this research effort."
Answered by AI
Does the eligibility for this experiment include those younger than 80 years old?
"This clinical trial is available to participates aged 18-99. Meanwhile, 53 studies are open for individuals under the age of majority while 723 trials target seniors above 65 years old."
Answered by AI
Are new participants being accepted into this research endeavor?
"As indicated by the clinical trials website, this research is still looking for individuals to take part. The original posting was on September 20th of last year and it has since been amended once in October 9th."
Answered by AI
What is the current sample size for this experiment?
"Affirmative. Data on clinicaltrials.gov confirms that this medical experiment, initially posted September 20th of 2023, is actively enrolling participants. 620 individuals must be enrolled across 5 sites for the research to go ahead."
Answered by AI
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