← Back to Search

Checkpoint Inhibitor

ABP 206 vs Nivolumab for Melanoma

Phase 3
Recruiting
Research Sponsored by Amgen
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
Must not have
Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma
Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte-associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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 below
Select...
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.
Select...
My melanoma cannot be removed by surgery and may have spread.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received treatment for advanced melanoma before.
Select...
I have been treated with specific immune-targeting medications before.
Select...
I have untreated brain metastases.
Select...
I have an active autoimmune disease.
Select...
I have been diagnosed with eye melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

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
1,420 Previous Clinical Trials
1,382,330 Total Patients Enrolled
23 Trials studying Melanoma
18,886 Patients Enrolled for Melanoma
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,245 Total Patients Enrolled
13 Trials studying Melanoma
2,359 Patients Enrolled for Melanoma
~413 spots leftby Jan 2027
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