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Monoclonal Antibodies

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
At least 18 years of age
Advanced Melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization through 12 months (or until rfs criteria is met)
Awards & highlights

Study Summary

This trial studies if a new drug is as safe, effective, and accepted by the body as an existing one for melanoma patients who have had surgery.

Who is the study for?
This trial is for adults over 18 with advanced melanoma that's been surgically removed within the last 12 weeks. Participants should be relatively healthy, with a performance status showing they can carry out daily activities (ECOG score of 0 or 1). They must have tumor tissue available for testing and cannot have had previous cancer treatments, autoimmune diseases, severe allergies to monoclonal antibodies, ocular melanoma, or require systemic immunosuppression.Check my eligibility
What is being tested?
The study is comparing ABP 206 to two versions of Nivolumab: one licensed in the US (FDA-licensed) and another authorized in Europe (EU-authorized). It aims to see if ABP 206 works similarly in terms of pharmacokinetics (how the drug moves through the body), effectiveness, safety profile, and whether it triggers immune responses against itself.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions such as inflammation in various organs like lungs or intestines; skin issues; hormonal gland problems; infusion reactions during administration; fatigue; and possibly other symptoms similar to those observed with Nivolumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition is advanced melanoma.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tumor tissue from surgery is available for testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization through 12 months (or until rfs criteria is met)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization through 12 months (or until rfs criteria is met) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
Secondary outcome measures
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
Maximum Observed Serum Concentration at Steady State (Cmax_ss)
Number of Subjects With Anti-drug Antibodies (ADAs)
+8 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
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%
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

3Treatment 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: FDA-licensed NivolumabActive Control1 Intervention
Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
Group III: EU-authorized NivolumabActive Control1 Intervention
Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,969 Total Patients Enrolled
23 Trials studying Melanoma
19,257 Patients Enrolled for Melanoma
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,481 Total Patients Enrolled
13 Trials studying Melanoma
2,730 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.

Is the age range for this trial's participants encompassing individuals over 25 years old?

"This research is accepting participants aged 18 years and older, but not exceeding 99."

Answered by AI

Has ABP 206 been sanctioned by the Federal Drug Administration?

"Extensive clinical data indicate ABP 206's safety, granting it an assessment score of 3."

Answered by AI

Does this clinical trial currently have open enrollment?

"Affirmative. Per the information available on clinicaltrials.gov, this study is currently accepting participants. It was originally published to the site on July 26th 2023 and its details were last amended October 12th of that same year. 249 individuals need to be enrolled from 39 different medical sites in order for the trial to move forward."

Answered by AI

Are there several sites in North America running this clinical trial?

"Individuals with the necessary criteria can seek enrollment at these notable medical centers: Severance Hospital in Seoul, Yonsei University Health System, IRST S.R.L in Meldola Forli-Cesena, and Hospital Umum Sarawak in Kuching Sarawak; plus 39 other sites globally."

Answered by AI

What is the aggregate quantity of participants in this trial?

"Amgen, the study's sponsor, requires 249 eligible patients to execute this trial. The locations of these clinics are diverse and include Severance Hospital; Yonsei University Health System in Seoul; Seoul Teugbyeolsi [Seoul-T'ukpyolsi]; and Istituto Romagnolo Per Lo Studio DeI Tumori Dino Amadori IRST S.R.L., located in Meldola, Forli - Cesena."

Answered by AI

What criteria must a participant meet to be considered for enrollment in this clinical trial?

"This trial is aimed at testing the efficacy of a novel treatment for melanoma in 249 individuals aged 18 to 99. The eligibility criteria are as follows: minimum age requirement of 18 years, removal of all detectable tumours through surgery within 12 weeks, advanced stage Melanoma, availability of tissue samples from affected areas and Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1."

Answered by AI

What aims are scientists hoping to accomplish with this research endeavor?

"The primary purpose of this 28-day study is to measure the Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS). Other goals include assessing Treatment-Emergent Serious Adverse Events, Maximum Observed Serum Concentration Following First Dose (Cmax_dose 1) and serum concentrations at Predose (Ctrough)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
2023. "A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05907122.
~156 spots leftby Jul 2025
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