Research & Innovation

Melanoma Clinical Trials

Clinical Trials

BMS CA224127

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma (NCT 05625399).

Physician & Study Coordinator

Study Coordinator

Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788

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Synopsis

The purpose of this research is to learn more about different ways (injecting under the skin versus given directly into a vein) to give the same study drug. For this study, a combination of two drugs (antibodies), called nivolumab and relatlimab, that work in different ways allowing your immune system to fight against cancer cells will be given. The primary objective of this study is to look at how much the study drug will be taken up (absorbed) in your body when given under your skin (subcutaneously) and if we will get comparable drug levels in the blood with this route, versus given directly into a vein (intravenously). These two ways of giving the drug will also be compared for how safe and effective they are.

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Eligibility Criteria
  • Histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC 8th edition staging system
  • Participants must be treatment-naïve (no prior systemic anticancer therapy for unresectable or metastatic melanoma). Note that the following prior adjuvant or neoadjuvant melanoma therapies are allowed if all related adverse events have either returned to baseline or stabilized
    • i) Anti-PD-1 or anti-CTLA-4 therapy with at least 6 months between the last dose and date of recurrence
    • ii) Interferon therapy with the last dose at least 6 weeks prior to randomization
    • iii) BRAF- or MEK-inhibitor-containing adjuvant therapy regimens with at least 6 months between the last dose and date of recurrence
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1
  • Participants must have a documented LDH result during the screening period within 14 days prior to randomization
  • Participants must have a known BRAF V600 mutation status, or consent to BRAF V600 mutation testing per local institutional standards during the Screening Period with the sample collected within 3 months prior to randomization
  • Participants must not have active brain metastases or leptomeningeal metastases

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Alliance A071701

Genomically-Guided Treatment Trial in Brain Metastases (NCT03994796)

Physician & Study Coordinator

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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Synopsis

This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

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Eligibility Criteria
  • Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

  • Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

  • Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

  • Patients must be able to undergo MRI with contrast

  • Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

  • For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

  • For TNBC, patients must have had at least one chemotherpy in the metastatic setting

  • For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

  • For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

  • For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

  • No known current diffuse leptomeningeal involvement

  • No surgery within 2 weeks prior to or after registration

  • No chemotherapy within 14 days prior to registration

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ECOG-ACRIN EA6194 ClinicalTrials.gov identifier NCT04708418

Physician & Study Coordinator

Study Coordinator

Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788

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Synopsis

This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.

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Eligibility Criteria

>= 18 years old

Diagnosis of melanoma by AJCC 8th edition:

  • T0, TX or T1-4 and
  • N2b, N2C, N3b or N3c

Patients may have a presentation with primary melanoma with concurrent regional nodal and/or in-transit metastasis; or patients may have a history of primary melanoma or unknown primary melanoma presenting with clinically detected regional nodal and/or in-transit recurrence; and may belong to any of the following groups:

  • Primary cutaneous melanoma with clinically apparent regional lymph node metastases and/or in-transit metastases
  • Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
  • Primary cutaneous melanoma with concurrent nodal disease involving a single regional nodal group
  • Clinically detected nodal melanoma (if single site) arising from an unknown primary
  • In-transit cutaneous metastases with or without regional lymph node involvement permitted if considered potentially surgically resectable at baseline

Mucosal and uveal melanoma are excluded

Patients must be a candidate for definitive surgery and have met with the treating surgical oncologist prior to entry on study

Patients must have injectable and measurable disease

No prior systemic therapy for melanoma including immunotherapy and BRAF/MEK inhibitors and/or TLR-9 agonist

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Iovance IOV-MEL-301

A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma (NCT 05727904).

Physician & Study Coordinator

Study Coordinator

Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788

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Synopsis

The purpose of this research study is to learn whether the study treatment called lifileucel plus pembrolizumab is as good, the same better or worse than treatment with pembrolizumab alone. Lifileucel is a type of immunotherapy called tumor infiltrating lymphocytes (TIL) and is made up of specialized white blood cells known a lymphocytes, or T cells, obtained from a piece of the patient’s tumor. A surgery will be conducted to obtain fresh tumor tissue and sent to the study sponsor’s manufacturing facility to process and manufacture the TIL product.

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Eligibility Criteria

Your study doctor will determine whether this clinical trials is an appropriate option for you. Some key eligibility criteria are as follows:

  • Patients must be aged 18-70 at time of signing the informed consent form
  • Confirmed diagnosis of stage IIIC, IIID, or IV unresectable or metastatic melanoma
  • ECOG performance status of 0 or 1 and an estimated life expectancy of > 6 months
  • Patients must have at least one resectable lesion with an estimated minimum diameter of 1.5 cm for lifileucel generation, AND will have at least one measurable lesion as defined by RECIST v.1.1 after surgical resection
  • Patients must have an LVEF >45% and is NYHA Class 1
  • Patients must have FEV1/FVC >70% or FEV1 >50% post-bronchodialator if they have a history of ≥ 20 pack-years, ceased smoking with the past 2 years or continues to smoke, has a history of COPD, has nay S/S of respiratory disfunction or history of pleural drainage within the past 3 months
  • Uveal/ocular melanoma is not allowed
  • Patients must not have symptomatic untreated brain metastases
  • Patients may not have had prior therapy for metastatic disease or more than one prior line of therapy
  • If BRAF V600 positive, patients must have received prior BRAF +/- MEK inhibitor and ICI therapy
  • Patients may not be taking systemic steroid therapy > 10 mg/day of prednisone

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Regeneron R3767-ONC-2055

A Phase 3 Trial of Fianlimab (ANTI-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-Risk Melanoma (NCT 05608291).

Physician & Study Coordinator

Study Coordinator

Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788

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Synopsis

The purpose of this research is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in participants that have had melanoma removal surgery but are still at high risk for recurrence of the disease. The study will compare two different doses of the investigational drugs, fianlimab and cemiplimab, versus the standard approved regimen of pembrolizumab. Approximately 1,530 patients are expected to enroll worldwide.

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Eligibility Criteria

Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Histologic diagnosis of stage IIC, III, or IV melanoma that is completely surgically resected within 12 weeks prior to trial randomization (cutaneous, acral or mucosal are permitted)
  • Complete surgical resection is defined as negative microscopic margins on resected primary tumors along with SLNB. Complete lymph node dissection in the case of a positive SLNB is not mandatory provided the patient is clinically lymph node negative and margins are clear
  • All patients must have disease-free status documented by complete physical exam and radiology imaging within 4 weeks prior to randomization
  • No prior systemic or radiation therapy for melanoma within previous 5 years, except for stage IV M1d patients who may have had prior RT to the CNS following radical resection
  • All patients must provide minimum of 25 slides of resected tumor tissue sample for biomarker sa
  • ECOG PS 0-1
  • Uveal melanoma is excluded
  • No ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease requiring systemic treatment with immunosuppressive agents

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SWOG 2015 (MelMarT-II)

Melanoma Margins Trial (MelMarT): A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma (NCT 03860883).

Physician & Study Coordinator

Study Coordinator

Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788

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Synopsis

This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma.

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Eligibility Criteria
  • Patients must have stage II primary invasive cutaneous melanoma (including head, neck, truck, extremity, scalp, palm or sole) with Breslow thickness >2mm without ulceration, or >1mm with ulceration (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy and subsequent histopathological analysis
  • An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma
  • Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis
  • Patients must have an ECOG PS of 0 or 1
  • Patients may not have uncertain diagnosis of melanoma, i.e. 'melanocytic lesion of unknown malignant potential
  • Patients who have undergone WLE at the site of primary index lesion, are unable or ineligible to undergo staging SLNB, or have a history of previous or concurrent invasive melanoma are excluded- Patients must not have physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional or distant metastatic melanoma
  • Subungual, pure desmoplastic or neurotropic, mucosal, uveal melanomas are excluded. The cutaneous lesion may not be located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear
  • Planned adjuvant radiotherapy to the primary melanoma after WLE is not permitted

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UKY-MCC-MEL-11-PMC

A Phase I Study of Nilotinib in Combination with Dabrafenib and Trametinib in BRAF V600 Mutant Metastatic Melanoma after Progression on BRAF/MEK Inhibition (NCT 04903119).

Physician & Study Coordinator

Study Coordinator

Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788

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Synopsis

The purpose of this study is to determine the most effective dose for nilotinib when combined with trametinib and dabrafenib and to gather information about the safety and effectiveness of this combination of drugs for patients with BRAF V600 mutated metastatic or unresectable melanoma.

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Eligibility Criteria
  • Histologic diagnosis of metastatic or unresectable melanoma
  • BRAF V600 mutation documented via any CLIA-certified mutation testing
  • Patients must have failed any BRAFi/MEKi regimen and be off of this regimen for a minimum of 7 days before starting protocol therapy
  • Patients may have had prior immunotherapy for metastatic disease (although NOT mandatory). Other prior therapies are not allowed, with the exception of radiation
  • ECOG performance status ≤ 1
  • Patients with treated brain metastases are eligible if follow-up brain imaging 4 weeks or longer after CNS-directed therapy shows no evidence of progression
  • RECIST 1.1 measurable disease
  • Patients may not be taking proton pump inhibitors, drugs or substances known to prolong QT interval, or CYP3A inhibitors and inducers, or CYP2C8 inhibitors

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