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A Study of Subcutaneous Nivolumab + Relatlimab FDC in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)
EU CTIS ID: 2022-500967-11-00
What this study is testing
The primary objective of this study is to assess whether the amount of study drug (both nivolumab and relatlimab) in your body when given under the skin (subcutaneously) is not different compared to study drug given directly into a vein (intravenously).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 12 years of age. If age ≥12 to <18 years, must weigh ≥ 40 kg
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% (if age ≥ 12 to < 18 years). The Performance Status/Score describes the patient’s ability to care for themselves, perform daily physical activities (eg, walking, working).
- Confirmed Stage III (unresectable/unable to remove with surgery) or Stage IV (metastatic/spread to other parts of the body) melanoma, per American Joint Committee on Cancer (AJCC) staging system (8th edition)
- Treatment-naive (ie, no prior systemic anticancer therapy) except for select prior adjuvant or neoadjuvant melanoma therapies if all related adverse events have returned to baseline or stabilized.
- Measurable disease per RECIST v1.1 (a standard way to measure how well a cancer patient responds to treatment)
You likely can't join if
- Known active brain/leptomeningeal metastases (condition in which cancer cells spread from the original (primary) tumor to the meninges (thin layers of tissue that cover and protect the brain and spinal cord)
- Female who are pregnant or breastfeeding
- Brain disease treated with whole brain radiation
- Known ocular melanoma (melanoma in or around the eye)
- Known/suspected autoimmune disease (condition in which the body's immune system mistakes its own healthy tissues as foreign and attacks them) except for Type I diabetes mellitus, hypothyroidism (condition where the thyroid doesn't create and release enough thyroid hormone into the bloodstream slowing down the metabolism) only requiring hormone replacement therapy, certain skin disorders not requiring systemic treatment or condition not expected to recur without external trigger
- History of myocarditis (inflammation of the heart muscle)
See the full eligibility criteria
- Age ≥ 12 years of age. If age ≥12 to <18 years, must weigh ≥ 40 kg
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% (if age ≥ 12 to < 18 years). The Performance Status/Score describes the patient’s ability to care for themselves, perform daily physical activities (eg, walking, working).
- Confirmed Stage III (unresectable/unable to remove with surgery) or Stage IV (metastatic/spread to other parts of the body) melanoma, per American Joint Committee on Cancer (AJCC) staging system (8th edition)
- Treatment-naive (ie, no prior systemic anticancer therapy) except for select prior adjuvant or neoadjuvant melanoma therapies if all related adverse events have returned to baseline or stabilized.
- Measurable disease per RECIST v1.1 (a standard way to measure how well a cancer patient responds to treatment)
- Known active brain/leptomeningeal metastases (condition in which cancer cells spread from the original (primary) tumor to the meninges (thin layers of tissue that cover and protect the brain and spinal cord)
- Female who are pregnant or breastfeeding
- Brain disease treated with whole brain radiation
- Known ocular melanoma (melanoma in or around the eye)
- Known/suspected autoimmune disease (condition in which the body's immune system mistakes its own healthy tissues as foreign and attacks them) except for Type I diabetes mellitus, hypothyroidism (condition where the thyroid doesn't create and release enough thyroid hormone into the bloodstream slowing down the metabolism) only requiring hormone replacement therapy, certain skin disorders not requiring systemic treatment or condition not expected to recur without external trigger
- History of myocarditis (inflammation of the heart muscle)
- Condition requiring systemic treatment with corticosteroid (> 10 mg daily prednisone equivalent) or other immunosuppressive agent within 14 days of treatment, except for inhaled/topical steroid or adrenal hormone (hormone produced by gland that sits on top of kidney) replacement therapy in absence of active autoimmune disease
- Cancer requiring treatment within 2 years prior to randomization/evidence of disease, except for basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment
- Prior immune checkpoint inhibitor therapies, within 6 months prior to start of study treatment
- Prior radiation therapy within 2 weeks prior to first study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Brazil
- Israel
- United Kingdom
- Chile
- Australia
- Colombia
- United States
- Canada
- Switzerland
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Brazil; Israel; United Kingdom; Chile; Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.