What is the mechanism of action of this treatment?

The most common treatments for melanoma, particularly advanced stages, include immune checkpoint inhibitors such as PD-1 inhibitors (e.g., nivolumab and pembrolizumab). These drugs work by blocking the programmed death-1 (PD-1) receptor on T-cells, preventing it from binding to its ligand PD-L1 on tumor cells. This blockade reactivates T-cells, allowing them to recognize and attack melanoma cells more effectively. This mechanism is crucial for melanoma patients as it enhances the body's immune response against cancer, potentially leading to better control of tumor growth and improved survival outcomes.

What side effects are associated with this type of intervention?

The most common treatments for melanoma, particularly those involving PD-1 inhibitors like nivolumab (OPDIVO®), can lead to a range of side effects. These include skin reactions (such as rash and pruritus), endocrine events (like thyroid dysfunction), and gastrointestinal issues (such as diarrhea). Immunotherapy with PD-1 inhibitors may also cause immune-related adverse events, including pneumonitis, hepatitis, and colitis. Combination therapies with CTLA-4 inhibitors (e.g., ipilimumab) can increase the frequency and severity of these side effects, leading to higher rates of serious adverse reactions such as pneumonia, febrile neutropenia, and acute kidney injury.

What prior FDA approvals exist?

The FDA has approved several PD-1 inhibitors for the treatment of melanoma. Nivolumab (Opdivo) and pembrolizumab (Keytruda) are prominent examples. Nivolumab is approved for use in patients with progression after chemotherapy, and pembrolizumab has been approved for various advanced solid tumors, including melanoma, based on its efficacy in improving progression-free survival and overall survival. These approvals are based on data from multiple clinical trials demonstrating their effectiveness in treating advanced melanoma.

What other types of research exist?

Promising novel alternatives to ABP 206 (PD-1 inhibition) for melanoma patients include: 1) CEACAM1 immune checkpoint inhibitors, which are in the development pipeline and show potential in disarming tumor escape mechanisms. 2) Combination therapies such as talimogene laherparepvec (T-VEC) plus pembrolizumab, which have shown efficacy in advanced melanoma. 3) CTLA-4 inhibitors like ipilimumab, either alone or in combination with PD-1 inhibitors, which continue to be a cornerstone in melanoma treatment.

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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

Must not have

Ocular or uveal melanoma or history of carcinomatosis meningitis

Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization through 12 months (or until rfs criteria is met)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug, ABP 206, against an existing drug, OPDIVO® (nivolumab), in patients who have had surgery for advanced melanoma. The goal is to see if ABP 206 is as effective and safe as OPDIVO® in preventing the cancer from returning by helping the immune system fight cancer cells. Nivolumab, marketed as OPDIVO®, has been used in various treatments for melanoma, showing improved outcomes in patients with advanced melanoma.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had eye melanoma or cancer spread to the lining of my brain.

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I have been on immunosuppressive drugs within the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization through 12 months (or until rfs criteria is met)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 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%

Tinnitus

10%

Cushingoid

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for melanoma, particularly advanced stages, include immune checkpoint inhibitors such as PD-1 inhibitors (e.g., nivolumab and pembrolizumab). These drugs work by blocking the programmed death-1 (PD-1) receptor on T-cells, preventing it from binding to its ligand PD-L1 on tumor cells. This blockade reactivates T-cells, allowing them to recognize and attack melanoma cells more effectively. This mechanism is crucial for melanoma patients as it enhances the body's immune response against cancer, potentially leading to better control of tumor growth and improved survival outcomes.

Role of targeted immunotherapy for pancreatic ductal adenocarcinoma (PDAC) treatment: An overview.