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Clinical Study of Fianlimab in Combination With Cemiplimab versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
EU CTIS ID: 2023-505772-30-00
What this study is testing
To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS)
- 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 on the date of providing informed consent
- Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease: a. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. b. Patients with acral and mucosal melanomas are eligible. Accrual of these patients is limited to approximately 10% of the total population enrolled. Accrual will be limited to 10% of the total population.
- Measurable disease per RECIST v1.1: a. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available. b. Cutaneous lesions should be evaluated as non-target lesions
- Performance status: a. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. b. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
- Anticipated life expectancy of at least 3 months
You likely can't join if
- Uveal melanoma
- Other protocol-defined Inclusion/ Exclusion criteria apply
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection
- Unknown BRAF V600 mutation status as described in the protocol
- Systemic immune suppression: a. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder. b. Other clinically relevant forms of systemic immune suppression
See the full eligibility criteria
Who can join
- Age ≥12 years on the date of providing informed consent
- Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease: a. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. b. Patients with acral and mucosal melanomas are eligible. Accrual of these patients is limited to approximately 10% of the total population enrolled. Accrual will be limited to 10% of the total population.
- Measurable disease per RECIST v1.1: a. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available. b. Cutaneous lesions should be evaluated as non-target lesions
- Performance status: a. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. b. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
- Anticipated life expectancy of at least 3 months
What rules you out
- Uveal melanoma
- Other protocol-defined Inclusion/ Exclusion criteria apply
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection
- Unknown BRAF V600 mutation status as described in the protocol
- Systemic immune suppression: a. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder. b. Other clinically relevant forms of systemic immune suppression
- Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
- History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
- Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they: a. Received radiotherapy or another appropriate standard therapy for the brain metastases; b. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment; c. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment; d. Are asymptomatic with a single untreated brain metastasis <10 mm in size
- Participants with a history of myocarditis
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Peru
- Brazil
- Canada
- Georgia
- Mexico
- Argentina
- South Africa
- United Kingdom
- Turkey
- Australia
- United States
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, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Peru; Brazil; Canada; Georgia; Mexico and 6 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.