Quality Awards
Melanoma / Skin Clinical Trials
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
The purpose of this research study is to compare any good and bad effects of giving ipilimumab, nivolumab, and GM-CSF (Sargramostim) at the same time compared to just ipilimumab and nivolumab together. GM-CSF is given to increase your body’s production of white blood cells and also help enhance the function of the white blood cells. This research study will allow researchers to know if adding this to the combination of ipilimumab and nivolumab is better, the same or worse than the usual approach. GM-CSF is an injection that is self-administered at home.
Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Age >/= 18 years
- Patients must have unresectable (not able to be surgically removed) stage III or IV melanoma
- Patients may not have had prior treatment with nivolumab or ipilimumab for metastatic melanoma
- BRAF mutational status of the melanoma must be known prior to study entry
- Patients must not have received live vaccines within 30 days of study entry
- Patients must not have autoimmune disorders or conditions of immunosuppression that require ongoing treatment with systemic corticosteroids or other systemic immunosuppressants
- Patient must not have active brain or central nervous system metastases; Patients treated brain metastases that are stable for at least 4 weeks following treatment and have not taken any steroids for 14 days are allowed
- Patients with human immunodeficiency virus (HIV) infection are ineligible; due to the mechanism of action of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient are unknown
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
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.
>= 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
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
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.
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
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
The purpose of this research study is to test the safety and efficacy of the study drug MK-4280A in patients with certain kinds of solid tumors. For Cohort A, participants will receive either the investigational agent MK-4280A or pembrolizumab before and after surgery for cutaneous squamous cell skin cancer (cSCC). After surgery, patients may also receive radiation therapy if recommended by their physician.
Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Patients must have a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy
- Stage II to IV disease without distant metastasis
- Patients may not have had any prior systemic therapy for cSCC, but may have had prior surgical resections of cSCC
- Prior in-field radiation therapy to the index lesion is not allowed
- Patients must have adequate organ function, ECOG PS of 0-1 and greater than 3 months life expectancy
Physician
William Smith, MD
The purpose of this research is to determine the recommended dose(s), safety, efficacy and tolerability of the study drug NBTXR3. NBTXR3 is a sterile white suspension made of hafnium oxide nanoparticles that will be injected directly into the tumor. NBTXR3 is an experimental drug made of extremely small particles with a special coating designed to get inside and stay inside cancer cells. These particles are designed to improve the benefit of Radiation Therapy to treat your cancer. It will be directly injected into a tumor that will then be radiated. After completion of radiation, patients will undergo treatment with immunotherapy with an anti-PD-1 inhibitor at the direction of their medical oncologist.
Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Patients must have biopsy-confirmed advanced/unresectable malignant solid tumor diagnosis indicated to receive an FDA-approved anti-PD-1 therapy that:
- Is inoperable locoregional recurrent or metastatic HNSCC with at least one lesion that is amenable to irradiation within head and neck region, lung or liver
- Is inoperable cancer of the lung, liver, kidney, bladder, cervix, breast (triple negative) or malignant melanoma that has metastasized to soft tissues, lung (including mediastinal lymph nodes) or liver with at least one lesion that is amenable to irradiation
- Patients must have received prior anti-PD-1 therapy and meet criteria consistent with anti-PD-1 primary or secondary resistance or have not received anti-PD-1 therapy (i.e., anti-PD1 naïve)
- Patients must have at least one tumor lesion that can be accurately measured according and is amenable for intratumoral injection and amenable for irradiation, as determined by the study investigator
- Patients cannot have a history of immune-related adverse events related to the administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure.
- Symptomatic central nervous system metastases and/or carcinomatous meningitis is not allowed
- Active autoimmune disease that has required systemic treatment in 1 year before study treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is not allowed
- Extensive metastatic disease burden defined as more than five lesions overall including the primary tumor is not allowed
- Patients must not have received prior systemic anti-neoplastic therapy, including investigational agents, within 4 weeks prior to NBTXR3 injection
- Patient must not have received prior therapy with a checkpoint inhibitor (e.g., anti-CTLA-4, anti-PD-1/L1, and/or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within two weeks prior to NBTXR3 injection
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
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.
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
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
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.
- 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
Study Coordinator
Amy Grossman, RN
email: Amy.Grossman@sluhn.org
phone: 484-658-1788
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.
- 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
