ABP 206 vs Nivolumab for Melanoma

Recruiting at 296 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

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.

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

Nivolumab has shown promise in treating melanoma, with studies indicating that nearly one-quarter of patients with advanced melanoma experienced a reduction in tumor size. Additionally, the FDA approved Nivolumab for melanoma treatment based on a significant response rate, with many patients experiencing long-lasting benefits. ^{1 2 3 4 5}

Is Nivolumab safe for treating melanoma?

Nivolumab, also known as Opdivo, has been studied in several trials for melanoma, showing that most side effects are mild, like fatigue and skin issues, and serious side effects are less common. No deaths directly related to the drug were reported, and most side effects resolved with treatment. ^{5 6 7 8 9}

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

ABP 206 is a biosimilar to nivolumab, which is a drug that helps the immune system fight cancer by blocking a protein that suppresses immune responses. This makes it similar to existing treatments like nivolumab (Opdivo), but as a biosimilar, it may offer a more cost-effective option while providing similar benefits. ^{2 4 5 10 11}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 (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 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]

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 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]

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]

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 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]

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]

References

1. 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]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

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. United States 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. [2021]

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

Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 27 prospective clinical trials. [2022]

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

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

11. England 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). [2023]