570 Participants Needed

Subcutaneous Nivolumab + Relatlimab for Melanoma

(RELATIVITY-127 Trial)

Recruiting at 319 trial locations
Fl
BS
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not take systemic corticosteroids or other immunosuppressive medications within 14 days before starting the study treatment. Inhaled or topical steroids are allowed if you don't have an active autoimmune disease.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic corticosteroids or other immunosuppressive medications at least 14 days before starting the study treatment. However, inhaled or topical steroids and certain adrenal replacement doses are allowed.

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

In the RELATIVITY-047 trial, the combination of nivolumab and relatlimab significantly improved the time patients lived without their melanoma getting worse compared to nivolumab alone, while maintaining stable quality of life.12345

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

The RELATIVITY-047 trial showed that the combination of nivolumab and relatlimab significantly improved the time patients lived without their melanoma getting worse compared to nivolumab alone, while maintaining stable quality of life.12345

Is the combination of Nivolumab and Relatlimab safe for treating melanoma?

The combination of Nivolumab and Relatlimab, known as Opdualag, has been approved for treating advanced melanoma. While it improves survival, it is associated with more frequent serious side effects compared to Nivolumab alone.35678

Is the combination of Nivolumab and Relatlimab safe for treating melanoma?

The combination of Nivolumab and Relatlimab for melanoma has been shown to improve survival, but it is associated with more frequent serious side effects compared to Nivolumab alone.35678

What makes the drug Nivolumab + Relatlimab unique for treating melanoma?

Nivolumab + Relatlimab is unique because it combines two immunotherapy drugs that target different immune checkpoints, PD-1 and LAG-3, to enhance the body's immune response against melanoma. This fixed-dose combination has shown improved progression-free survival in patients with unresectable or metastatic melanoma compared to nivolumab alone.12369

What makes the drug Nivolumab + Relatlimab unique for treating melanoma?

Nivolumab + Relatlimab is unique because it combines two immunotherapy drugs that target different immune checkpoints, PD-1 and LAG-3, to enhance the body's immune response against melanoma. This fixed-dose combination has shown improved progression-free survival compared to nivolumab alone in patients with unresectable or metastatic melanoma.12369

What is the purpose of this trial?

This trial is testing two ways of giving a combination of two drugs, nivolumab and relatlimab, to patients with advanced melanoma that hasn't been treated before. One method involves injecting the drugs under the skin, while the other involves injecting them into a vein. These drugs help the immune system recognize and attack cancer cells.

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people aged 12 and older with Stage III (unresectable) or Stage IV (metastatic) melanoma, as per AJCC staging. They must have measurable disease by CT or MRI, be in good physical condition (ECOG ≤1), and adolescents must weigh at least 40 kg. It's not for those with ocular melanoma, a history of myocarditis, or on high-dose steroids/immunosuppressants.

Inclusion Criteria

My melanoma is at Stage III (unresectable) or IV (metastatic).
I am very active or have minor symptoms that don't limit my daily activities.
My melanoma is at Stage III (unresectable) or Stage IV (metastatic).
See 2 more

Exclusion Criteria

I do not have eye melanoma.
I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
I have never had myocarditis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either subcutaneous or intravenous administration of nivolumab + relatlimab FDC

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

  • Nivolumab + Relatlimab Fixed-dose Combination (FDC)
Trial Overview The study tests if the subcutaneous form of Nivolumab + Relatlimab combination is as effective as the intravenous version in untreated metastatic/unresectable melanoma patients. The focus is on comparing drug exposure levels between these two methods.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + Relatlimab FDC SCExperimental Treatment2 Interventions
Group II: Nivolumab + Relatlimab FDC IVActive Control1 Intervention

Nivolumab + Relatlimab Fixed-dose Combination (FDC) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Opdualag for:
  • Advanced melanoma (unresectable or metastatic)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

The combination of nivolumab and ipilimumab, two immune checkpoint inhibitors, is a promising treatment for advanced melanoma, enhancing the body's immune response against the cancer.
Adding denosumab to this treatment may further improve anti-tumor effects by counteracting the immunosuppressive environment created by CD8+ T cells, as suggested by recent reports.
Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy.Yoshida, S., Fujimura, T., Kambayashi, Y., et al.[2020]
Combining ipilimumab with nivolumab can significantly improve treatment outcomes for advanced melanoma patients, but ipilimumab alone is not effective for those resistant to nivolumab.
A case study demonstrated that a nivolumab-resistant patient with multiple in-transit melanomas responded well to a combination of ipilimumab and topical imiquimod, suggesting a potential new treatment strategy for similar cases.
Successful Treatment of Nivolumab-Resistant Multiple In-Transit Melanomas with Ipilimumab and Topical Imiquimod.Fujimura, T., Kambayashi, Y., Sato, Y., et al.[2020]
In the RELATIVITY-047 trial, the combination of nivolumab and relatlimab (NIVO + RELA) significantly improved progression-free survival in patients with advanced melanoma compared to nivolumab alone, with a median follow-up of 19.3 months.
Despite a higher incidence of severe treatment-related adverse events with the combination therapy, patients reported stable health-related quality of life, indicating that the benefits of NIVO + RELA outweigh the risks.
Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial.Schadendorf, D., Tawbi, H., Lipson, EJ., et al.[2023]

References

Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy. [2020]
Successful Treatment of Nivolumab-Resistant Multiple In-Transit Melanomas with Ipilimumab and Topical Imiquimod. [2020]
Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. [2023]
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. [2022]
Nivolumab + ipilimumab ups melanoma response. [2018]
Nivolumab Plus Relatlimab: First Approval. [2022]
Nivolumab monotherapy or in combination with ipilimumab for metastatic melanoma: systematic review and meta-analysis of randomized-controlled trials. [2023]
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. [2022]
9.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]
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