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New treatment option for Metastatic Melanoma
Official title ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
ClinicalTrials.gov ID: NCT07504796
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to investigate the use of ctDNA measurements to guide first-lien therapy choice for patients with advanced or metastatic melanoma. Primary endpoints include progression-free survival.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be ≥ 18 years old.
- Patients must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent from...
- Patients must be willing and able to comply with scheduled visits, laboratory tests, and other requirements of the study.
- Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients...
- Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site...
You likely can't join if
- Patients with carcinomatosis meningitis or a history of current ocular/uveal melanoma are excluded.
- Patients with a history of myocarditis.
- Patients with active, known, or suspected autoimmune disease requiring immunosuppression beyond 10 mg daily of prednisone. Patients with type I...
- Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other...
- Patients must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving...
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with or...
See the full eligibility criteria
Who can join
- Patient must be ≥ 18 years old.
- Patients must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent from (ICF) in accordance with regulatory and institutional guidelines. This...
- Patients must be willing and able to comply with scheduled visits, laboratory tests, and other requirements of the study.
- Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients with mucosal melanoma defined as unresectable stage III or...
- Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible.
- Patient must have at least one lesion for measurable disease per RECIST 1.1 guidelines (refer to section 8.1 for more information).
- Patients must have specimen required for study procedures, including either archived tumor tissue or fresh tissue and whole blood available, at baseline to send to Natera as part of screening for Signatera testing to be...
- Patient must be planned to initiate standard of care first-line therapy for metastatic disease
- Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical). Exceptions: Surgery for melanoma and/or...
- All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug. Imaging studies must include computerized tomography...
- The complete set of baseline radiographic images must be available before treatment initiation. Prior treatment with adjuvant IFN-alpha, adjuvant ipilimumab and/or nivolumab or pembrolizumab or BRAF/MEK therapy (e.g...
- Patients must have detectable ctDNA at baseline. A blood sample will be collected during the screening phase in order to determine if patients are eligible based on presence of ctDNA. Patients are permitted to start...
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients with prior or concurrent nonmelanoma malignancies whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are...
- Asymptomatic brain metastases are permitted. Patients who have received/will receive gamma knife radiotherapy or stereotactic body radiation therapy (SBRT) treated lesions are also eligible. Patients must be on \< 10 mg...
- All baseline laboratory requirements will be assessed and should be obtained within 14 days of C1D1. Screening laboratory values must meet the following criteria:
- white blood cells (WBCs) ≥ 2000/μL
- Neutrophils ≥ 1500/μL
- Platelets ≥ 100 × 10³/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance \> 40 mL/minute (using Cockcroft/Gault formula)
- Aspartate Aminotransferase (AST) ≤ 1.5 × ULN
- Alanine Aminotransferase (ALT) ≤ 1.5 × ULN
- Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert Syndrome who must have total bilirubin \< 3.0 mg/dL)
- Coagulation : Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR)
What rules you out
- Patients with carcinomatosis meningitis or a history of current ocular/uveal melanoma are excluded.
- Patients with a history of myocarditis.
- Patients with active, known, or suspected autoimmune disease requiring immunosuppression beyond 10 mg daily of prednisone. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis...
- Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of C1D1. Inhaled or topical steroids are...
- Patients must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases...
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with or would otherwise affect study participation.
- Known hypersensitivity to monoclonal antibodies
- Pregnancy
- Prior therapy for melanoma with the following exceptions which are allowed: 1) surgery for the melanoma lesion(s), 2) adjuvant RT after neurosurgical resection for CNS lesions or for resected locoregional disease, and...
- Any of the following laboratory abnormalities:
- Absolute Neutrophil Count (ANC) \< 1,500/μL or WBC \< 2,000 μL
- Platelet count \< 100,000/μL
- Hematologic growth factors are not allowed at screening or during the first cycle of treatment
- Hemoglobin \< 9 g/dL (\< 5.5 mmol/L; previous red blood cell (RBC) transfusion is permitted)
- Creatinine \> 1.5 × ULN
- AST or ALT \> 1.5 × ULN. For patients with liver metastasis AST or ALT \> 3 × ULN
- Serum total bilirubin \> 1.5 mg/dL or \> 3 × ULN for patients with hereditary benign hyperbilirubinemia
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. 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 ClinicalTrials.gov; the study team decides eligibility.