ABP 206 vs. Nivolumab for Melanoma

Recruiting at 123 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Auto-immune disease, 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: 12 months

256 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial requires that you do not take medications that suppress your immune system, like corticosteroids, within 14 days before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Nivolumab for melanoma?

Nivolumab has shown promising results in treating melanoma, with studies indicating that it can lead to a partial tumor response in nearly one-quarter of patients with advanced melanoma. Additionally, it has been approved by the FDA for use in patients with melanoma that has not responded to other treatments, demonstrating a meaningful and durable response rate. ^{1 2 3 4 5}

What is the safety profile of Nivolumab for melanoma treatment?

Nivolumab, also known as Opdivo, has been studied for safety in patients with advanced melanoma. Common side effects include fatigue, itching, diarrhea, and rash, with serious side effects occurring in about 10% of patients. Most side effects are mild and can be managed with standard guidelines, and no drug-related deaths were reported. ^{3 4 6 7 8}

How does the drug ABP 206 differ from other treatments for melanoma?

ABP 206 is a biosimilar to nivolumab, which is a drug that targets the immune system to help fight melanoma by blocking a protein called PD-1. This makes it similar to existing treatments like nivolumab, but as a biosimilar, it may offer a more cost-effective option while providing similar therapeutic effects. ^{1 2 3 9 10}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My condition is advanced melanoma.

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

Exclusion Criteria

I have had cancer treatment before.

Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABP 206 or Nivolumab until recurrence, unacceptable toxicity, or withdrawal, with a maximum of 1 year of treatment

12 months

Regular visits as per dosing schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Treatment Details

Interventions

• ABP 206
• Nivolumab

Trial Overview 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.

Participant Groups

Group I: ABP 206 Experimental Treatment 1 Intervention

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

Group II: FDA-licensed Nivolumab Active Control 1 Intervention

Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.

Group III: EU-authorized Nivolumab Active Control 1 Intervention

Subjects will receive Dose A of EU-authorized 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

Findings from Research

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 (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]

Nivolumab, an anti-PD-1 antibody, was administered to a 63-year-old female patient with metastatic melanoma after renal transplantation, highlighting the potential for anti-tumor activity in high-risk patients, despite the challenges of concurrent immunosuppression.

The patient experienced acute renal allograft rejection and renal failure shortly after starting nivolumab, indicating significant risks associated with this treatment in transplant recipients, but she later showed a positive clinical response after re-challenging with nivolumab while on hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. Ong, M., Ibrahim, AM., Bourassa-Blanchette, S., et al.[2023]

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]

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]

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]

A systematic review of 14 randomized controlled trials found that combining nivolumab (NIVO) with ipilimumab (IPI) significantly increases the risk of treatment-related adverse events (TRAEs) compared to NIVO alone, with an overall risk ratio of 1.11 for any grade TRAEs and 1.95 for severe (grade 3 or 4) TRAEs.

Specific adverse events were notably higher with the combination therapy, including colitis (RR = 4.52), pneumonitis (RR = 3.06), and diarrhea (RR = 1.68), indicating that while the combination may be effective, it comes with increased safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Induced by Nivolumab Plus Ipilimumab vs. Nivolumab Monotherapy among Cancer Patients: A Systematic Review and Meta-Analysis. Kamat, S., Patel, J., Brown, BR., et al.[2022]

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]

References

1. Georgia (Republic) 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)]. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse Events Induced by Nivolumab Plus Ipilimumab vs. Nivolumab Monotherapy among Cancer Patients: A Systematic Review and Meta-Analysis. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Serum Level of Soluble CD163 May Be a Predictive Marker of the Effectiveness of Nivolumab in Patients With Advanced Cutaneous Melanoma. [2020]