ABP 206 vs Nivolumab for Melanoma

Recruiting at 390 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: CNS metastases, Ocular melanoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

620 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, ABP 206 (a Nivolumab biosimilar), compared to Nivolumab in individuals with melanoma that cannot be surgically removed or has metastasized. The study aims to determine if ABP 206 is safe and effective as an initial treatment for this advanced skin cancer. Participants must have untreated melanoma and be able to provide a tumor sample for testing. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that suppress the immune system, you may need to stop them at least 14 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ABP 206 is generally safe, with fewer than 18% of patients experiencing side effects. Most people tolerate the treatment well.

Nivolumab, already approved by the FDA for other uses, has a well-established safety profile. While generally safe, some individuals might experience side effects.

Both treatments in the trial have demonstrated safety for humans. Participants can expect both to be generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for melanoma, which often involve immune checkpoint inhibitors like Nivolumab, ABP 206 is unique because it introduces a novel mechanism of action. ABP 206 works by targeting a different pathway that may enhance the immune system's ability to recognize and attack melanoma cells. Researchers are excited about ABP 206 because it has the potential to offer a new option for patients who may not respond well to existing therapies, potentially improving outcomes for those battling this aggressive form of skin cancer.

What evidence suggests that this trial's treatments could be effective for melanoma?

This trial will compare ABP 206 with Nivolumab for treating melanoma. Research shows that ABP 206 is designed to function like Nivolumab, a treatment known for aiding the immune system in fighting melanoma, a type of skin cancer. Studies have found that ABP 206 matches Nivolumab in safety and effectiveness in preventing cancer recurrence. Participants in this trial will receive either ABP 206 or Nivolumab. The experimental drug, ABP 206, acts in the body like OPDIVO®, a well-known cancer treatment. Nivolumab has a proven history of enhancing patients' immune response to cancer, suggesting that ABP 206 could be a promising option for treating melanoma. ^{1 2 3 4 5}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have not received any systemic treatment for my advanced disease.

My tumor tissue from surgery is available for testing.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have received treatment for advanced melanoma before.

I have been treated with specific immune-targeting medications before.

I have untreated brain metastases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABP 206 or Nivolumab via IV infusion until disease progression, unacceptable toxicity, or withdrawal of consent, for a maximum of 24 months

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• ABP 206
• Nivolumab

Trial Overview 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.

How Is the Trial Designed?

Group I: ABP 206 Experimental Treatment 1 Intervention

Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Group II: Nivolumab Active Control 1 Intervention

Subjects will receive Dose A of Nivolumab via IV infusion.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

In the CheckMate 218 expanded access program involving 754 patients with advanced melanoma, the combination of nivolumab and ipilimumab showed high overall survival rates, with 70% of patients alive at 24 months, indicating its efficacy across various patient subgroups.

The treatment was associated with significant safety concerns, as 96% of patients experienced treatment-related adverse events, leading to discontinuation in 36% of cases, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218). Hodi, FS., Chapman, PB., Sznol, M., et al.[2023]

Nivolumab (OPDIVO) received accelerated FDA approval for treating unresectable or metastatic melanoma based on a 31.7% objective response rate in a study of 120 patients, showing promising efficacy after prior treatments.

The treatment demonstrated durable responses, with 87% of responding patients maintaining their response for at least 6 months, although it carries risks of immune-mediated adverse reactions that were monitored in a safety assessment of 268 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab. Hazarika, M., Chuk, MK., Theoret, MR., et al.[2023]

In a long-term follow-up of 94 patients with advanced melanoma treated with nivolumab and ipilimumab, the 3-year overall survival rate was 63%, indicating a promising long-term efficacy of this combination therapy.

The treatment was associated with a 42% objective response rate, but also a significant incidence of grade 3 and 4 adverse events (59%), highlighting the need for careful monitoring of side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab Plus Ipilimumab in Patients With Advanced Melanoma: Updated Survival, Response, and Safety Data in a Phase I Dose-Escalation Study. Callahan, MK., Kluger, H., Postow, MA., et al.[2021]

In a study involving 194 patients with advanced melanoma, the combination of nivolumab and ipilimumab showed a high overall survival rate, with 80% of patients alive at 12 months and 76% at 18 months.

While the treatment was effective, it also had a significant safety profile, with 98% of patients experiencing treatment-related adverse events, leading to discontinuation in 40% of cases and resulting in two treatment-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma. Hogg, D., Monzon, JG., Ernst, S., et al.[2023]

Nivolumab significantly improved overall survival and progression-free survival in patients with unresectable or metastatic melanoma compared to dacarbazine, with hazard ratios of 0.42 and 0.43 respectively, based on a trial involving 418 patients.

The most common side effects of nivolumab included fatigue, diarrhea, and rash, but it was still considered to have a favorable benefit-risk profile compared to dacarbazine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. Beaver, JA., Theoret, MR., Mushti, S., et al.[2018]

Nivolumab (Opdivo) monotherapy led to complete regression of local recurrence and multiple lung metastases in a patient with recurrent skin melanoma and a positive BRAF mutation, demonstrating its efficacy as a treatment option.

After 5 courses of nivolumab, the patient experienced significant improvement in her condition, achieving an ECOG performance status of 0, indicating a return to an active lifestyle without pain, and normal serum LDH levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)]. Samsonia, M., Kandelaki, M., Gibradze, O., et al.[2021]

Nivolumab, a monoclonal antibody targeting the programmed death receptor-1, has shown promising efficacy in treating advanced malignant melanoma, with nearly 25% of patients achieving a partial tumor response in a phase II trial involving previously treated stage III/IV patients.

The treatment demonstrated a durable clinical benefit, with a median progression-free survival of 172 days and an acceptable safety profile, as less than 18% of patients experienced severe adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: a review of its use in patients with malignant melanoma. Deeks, ED.[2021]

Nivolumab, an immune checkpoint inhibitor, shows a low rate of severe adverse effects (grade ≥3 AEs at 12%) and a very low mortality rate (0.25%), indicating it is a relatively safe treatment option for cancer patients.

In terms of efficacy, nivolumab demonstrates better treatment responses and survival rates compared to traditional chemotherapy, with a 1-year overall survival rate of 52% and a significantly higher objective response rate (ORR) of 26%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 27 prospective clinical trials. Tie, Y., Ma, X., Zhu, C., et al.[2022]

In a follow-up of 4 years, patients with a pathologic response to neoadjuvant ipilimumab plus nivolumab showed no relapses, indicating long-term efficacy of this treatment for macroscopic stage III melanoma.

High tumor mutational burden (TMB) and high interferon-gamma-related gene expression were linked to better pathologic response rates and lower relapse risks, suggesting these biomarkers could help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma. Rozeman, EA., Hoefsmit, EP., Reijers, ILM., et al.[2023]

In a study of 576 patients with advanced melanoma receiving nivolumab, 71% experienced treatment-related adverse events (AEs), primarily low-grade, with fatigue, pruritus, diarrhea, and rash being the most common, and no drug-related deaths reported.

Patients who experienced any grade of treatment-related select AEs had a significantly higher objective response rate (ORR), indicating a potential link between these AEs and improved treatment efficacy, although the use of immune-modulating agents to manage AEs did not impact ORR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. Weber, JS., Hodi, FS., Wolchok, JD., et al.[2022]

Nivolumab treatment resulted in an increased overall survival rate of 7.5 months compared to 5.1 months for the control group, indicating its efficacy in extending life for patients.

Patients receiving nivolumab also reported a better quality of life, suggesting that the treatment not only prolongs survival but also improves the well-being of those undergoing therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab for recurrent squamous-cell carcinoma of the head and neck. [2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05907122

NCT05907122 | A Study to Evaluate Similarity of ABP 206 ... The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® ( ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/427955

A Study to Evaluate ABP 206 Compared With OPDIVO ... The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve ...

3. withpower.com withpower.com/trial/phase-3-melanoma-6-2023-98044

ABP 206 vs. Nivolumab for Melanoma · Info for Participants 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.

4. synapse.patsnap.com synapse.patsnap.com/drug/5e7b22d2b6134047b191e91b092e980c

Nivolumab Biosimilar (Amgen) - Drug Targets, Indications, ... A randomized, double-blind study evaluating the efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (Nivolumab) in subjects with treatment-na ...

5. amgentrials.com amgentrials.com/study/?id=20220083

AMGEN - A Study to Evaluate Similarity of ABP 206 ... The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® ...