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Medical advancements and improvements in how doctors treat disease are made possible by what we learn through clinical trials. Commonly done in a medical setting such as a hospital, clinical trials are research studies that evaluate the safety and effectiveness of new treatments, whether they are drugs, devices, or preventative and other therapeutic measures that can influence health. Patients who participate in clinical trials have the opportunity to access treatments before they are publically available and also help others by contributing to medical research.  

Atlantic Health System hospitals participate in numerous clinical trials in partnership with other research organizations and pharmaceutical or biotech sponsors. Please browse the listing of clinical trials below to learn more about our open and active studies. Our physicians are committed to finding the latest treatments within a variety of medical areas, with a particular focus on cancer, genetics and congenital disease, movement disorders such as Parkinson’s disease, pediatrics, valve disease, and women’s health. 

Showing 14 Results for skin cancer

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Skin Cancer
Open to Enrollment

A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the...

Investigator:
Eric Whitman, MD

body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with Pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

ID-LV305-2013-01 | PHASE I

Sponsor:
Immune Design Corp.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable
• Tumor histology consistent with one of the following: breast cancer, melanoma, non-small cell lung cancer (NSCLC), ovarian cancer (including fallopian tube carcinoma) or sarcoma
• Tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR
• If ovarian cancer, cancer antigen 125 (CA-125) must be ≥ 40 U/mL (unless patient has measurable disease which cannot be followed by CA-125), or if melanoma, LDH must be ≤ ULN
• Inadequate response, relapse, and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, except patients with NSCLC and breast cancer who must have experienced either an inadequate response and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies
• ≥ 18 years of age
• Life expectancy of ≥ 6 months per the investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• ECG without evidence of clinically significant arrhythmia or ischemia
• If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last ID-LV305 injection
• If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last ID-LV305 injection

Exclusion Criteria:
• Investigational therapy within 3 weeks prior to ID-LV305 dosing
• Prior administration of other NY-ESO-1-targeting immunotherapeutics
• Significant immunosuppression from:
a. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
b. Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy
• Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled ID-LV305 dosing
• Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent
• Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy
• Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
• Inadequate organ function including:
a. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophils count ≤ 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL
b. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ≤ 3.0 mg/dL)
c. Renal: Creatinine > 1.5x ULN
d. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN
• History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ)
• Active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active hepatitis B, hepatitis C or HIV infection
• Uveal melanoma
• Brain metastases considered unstable as:
a. Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
b. Associated with symptoms and/or findings; OR
c. Requiring corticosteroids or anticonvulsants in the prior 60 days
• Pregnancy or nursing

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Contact:
973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Skin Cancer
Open to Enrollment

A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma

This is a Phase 1b/2 open-label trial to assess the safety, tolerability, biologic-activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with advance or metastatic melanoma.

Investigator:
Eric Whitman, MD
DV3-MEL-01 | PHASE I/II

Sponsor:
Dynavax Technologies Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria: (Phase 1b and Phase 2)
• Histologically or cytologically confirmed unresectable in-transit (stage IIIc) or metastatic (stage IV) melanoma.
• At least 1 site of disease which must be palpable and easily accessible for intratumoral injection. A second measurable lesion is desirable in Phase 1 and required in Phase 2.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

Inclusion Criteria (Phase 2 Only)
• Expansion Cohort 2: Must have documented PD per RECIST 1.1 while receiving a prior FDA-approved anti-PD-1 therapy.

Exclusion Criteria: (Phase 1b and Phase 2)
• Stage IIIc melanoma considered resectable with curative intent.
• Is expected to require any other form of anti-cancer therapy while in the trial.
• Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• History of or current uveal or ocular melanoma.
• Active infection including cytomegalovirus.
• Active autoimmune disease requiring systemic treatment.
• History of interstitial lung disease.
• Known active central nervous system metastases or carcinomatous meningitis.

Exclusion Criteria (Phase 2, Expansion Cohort 1 Only).
• Prior therapy with combination of talimogene laherparepvec (T-VEC) and an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors or mechanisms (exceptions are prior BRAF inhibitor, single agent T-VEC, and ipilumumab, which are allowed.)
• Prior therapy with a anti-PD1/L1 agent

Exclusion Criteria (Phase 2, Expansion Cohort 2 only)
• Prior therapy with a combination of T-VEC and an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors or mechanisms (exceptions are prior ipilumumab, single agent T-VEC, nivolumab, pembrolizumab, or other anti-PD-1/L1 agents which are allowed).

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Contact:
973-971-7111
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Skin Cancer
Open to Enrollment

A Phase 2, Multicenter, Single-arm Study to Assess the Safety, Feasibility, and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of Metastatic Melanoma

Prospective, single-arm interventional study evaluating autologous tumor infiltrating lymphocyte (TIL) infusion (LN-144) followed by IL-2 after a non-myeloablative chemotherapy preparative regimen for the treatment of metastatic melanoma.

Investigator:
Eric Whitman, MD
C-144-01 | PHASE II

Sponsor:
Lion Biotechnologies, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria Patients must have:
• Measurable metastatic melanoma and at least one lesion that is resectable for TIL generation. The lesion must be of at least 1.5 cm in diameter and can be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization is less than or equal to three days).
• Undergone at least one prior systemic treatment for metastatic melanoma.
• Progressive disease after prior treatment.
• Be between 18 and 70 years of age, inclusive, at the time of consent.
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Be capable of participating and completing study procedures.
• Patients of childbearing potential or with partners of childbearing potential must be willing to practice birth control during treatment and for four months after receiving all protocol related therapy.
• Serum absolute neutrophil count (ANC) greater than 1000/mm3, hemoglobin greater than 9.0 g/dL, and platelet count greater than 100,000/mm3.
• Serum ALT/SGPT and AST/SGOT less than three times the upper limit of normal (<3x ULN), a calculated creatinine clearance of greater than 50 mL/min (>50 mL/min), and a total bilirubin less than or equal to 2 mg/dL (≤ 2 mg/dL). Patients with Gilbert's Syndrome must have a total bilirubin less than 3 mg/dL (<3 mg/dL).
• Seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
• EBV IgG positive to viral capsid antigen
• Not have received systemic therapy for melanoma for a minimum of four weeks prior to the point of enrollment. Prior therapy-related toxicities must have recovered to Grade 1 or less (CTCAE v4.03), except for alopecia or vitiligo.
Note: Patients may have undergone minor surgical procedures not involving general anesthesia within the past three weeks, as long as all toxicities have recovered to Grade 1 or less or as specified in the eligibility criteria.
• A minimum of at least five weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow antibody levels to decline.
• Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous treatment with ipilimumab, tremelimumab, anti-PD1 or anti-PD-L1 antibodies must have had a normal colonoscopy, including biopsy specimens.
• Ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments.
• Patients have provided written authorization for use and disclosure of protected health information.

Exclusion Criteria:
• Received prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
• More than three brain metastases. Note: Patients with fewer metastases may be eligible. If lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been definitively treated and stable for one month. Brain metastases with significant edema and metastases larger than 2 cm are exclusionary.
• Pregnant or breastfeeding.
• Systemic steroid therapy regimen defined as the need for chronic steroid use for at least seven or more days at a dose of 10 mg of prednisone or equivalent per day.
• Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced in the medical history by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
• History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or IL-2.
• History of coronary revascularization or ischemic symptoms.
• History of a positive HIV test or active Hepatitis B or C.
• Estimated glomerular filtration rate (eGFR) less than 40 mL/min using the Cockcroft Gault formula at Screening or have end-stage renal disorder requiring hemodialysis.
• An LVEF less than 45%. (Older patients [60 - 70 years] must have received an echocardiogram within the previous 60 days demonstrating LVEF ≥ 45%).
• History of cigarette smoking of at least 20 packs/year within the past two years that have a documented FEV1 (forced expiratory volume in one second) of less than or equal to 60% or symptoms of respiratory dysfunction.
• Had another primary malignancy within the previous three years (with the exception of carcinoma in situ of the breast, urothelial cancer in situ, and non-melanoma skin cancer that has been adequately treated)

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Contact:
973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Skin Cancer
Open to Enrollment

A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of combination of atezolizumab (ATZ), cobimetinib and vemurafenib compared with combination of ATZ placebo,...

Investigator:
Eric Whitman, MD

cobimetinib and vemurafenib in participants with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

CO39262 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Age greater than or equal to (>/=) 18 years
• Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (• Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
• Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
• Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority
• Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1
• Measurable disease according to RECIST v1.1
• Life expectancy >/=18 weeks
• For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to (• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment

Exclusion Criteria:

Cancer-Related Exclusion Criteria:
• Major surgical procedure within 4 weeks prior study treatment initiation
• Traumatic injury or palliative radiotherapy within 2 weeks prior study treatment initiation
• Active malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or other curatively treated malignancies from which the participant has been disease-free for at least 3 years

Ocular Exclusion Criteria:
• History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration

Cardiac Exclusion Criteria:
• History of clinically significant cardiac dysfunction
• Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50%

Central Nervous System (CNS) Exclusion Criteria:
• Untreated or actively progressing CNS lesions (carcinomatous meningitis)
• History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm); or leptomeningeal metastatic disease; or intracranial hemorrhage

Additional Exclusion Criteria:
• Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
• History of malabsorption or other clinically significant metabolic dysfunction
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia (example: bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• History of autoimmune disease
• Known clinically significant liver disease, inherited liver disease and active viral disease
• Active tuberculosis
• Treatment with therapeutic oral or intravenous (IV) antibiotics; or with a live, attenuated vaccine; or systemic immunosuppressive medication
• Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab, cobimetinib, or vemurafenib formulations

Contact:
973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Skin Cancer
Open to Enrollment

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients with Surgically Resected, Cutaneous Braf-Mutant Melanoma at High Risk for Recurrence

This multi-center, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF-mutation positive melanoma at high risk for recurrence. Patients will be randomized...

Investigator:
Eric Whitman, MD

to receive oral doses of vemurafenib 960 mg twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.

GO27826 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients with completely resected, histologically confirmed, Stage IIC or Stage III, cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or involved lymph node is determined to be positive using the cobas® BRAF V600 Mutation Test. Patients with Stage IIIA disease must have at least one lymph node metastasis measuring > 1 mm in diameter
• Patients must have been surgically rendered free of disease within 70 days of randomization
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Life expectancy of at least 5 years
• Patients must have fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
• Adequate hematologic, hepatic and renal function

Exclusion Criteria:
• History of any systemic therapy for the treatment of melanoma
• History of limb perfusion therapy
• History of radiotherapy for the treatment of melanoma
• Invasive malignancy other than melanoma at the time of enrollment or within 3 years prior to first dose of study treatment
• Family history of colon cancer syndromes
• History of clinically significant cardiac or pulmonary dysfunction
• Major surgical procedure within 4 weeks prior to first dose of study treatment
• Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus

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Contact:
973-971-7484
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Skin Cancer
Open to Enrollment

A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients

This multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duration is anticipated...

Investigator:
Eric Whitman, MD

to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.

ML28296

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population
Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome

Inclusion Criteria:
• Adult patients, >/= 18 years of age
• Patients with basal cell carcinoma (BCC) who meet either of the following definitions:
o Patients who were determined with advanced disease (aBCC) within 90 days prior to study enrollment, have not been diagnosed with basal cell carcinoma nevus syndrome (BCCNS) and have not been treated with an investigational or approved hedgehog pathway inhibitor
o Patients with aBCC who have not been diagnosed with BCCNS and who were previously treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)
o Patients with BCCNS who either have aBCC or multiple BCCs of any stage as defined by protocol (may include patients previously enrolled in Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP))
Exclusion Criteria:
• Participation in a clinical trial within 90 days prior to study enrollment that has either involved treatment of aBCC or involved treatment with an investigational or approved hedgehog pathway inhib

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Contact:
973-971-7484
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Skin Cancer
Open to Enrollment

A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating...

Investigator:
Eric Whitman, MD

patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

EA6134 | PHASE III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• STEP 1
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
• Women must not be pregnant or breast-feeding
◦ All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
◦ A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of child-bearing potential and sexually active males must agree to use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for the duration of their participation in the study, and for 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 23 weeks after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or abstain from sexual intercourse for at least 31 weeks after the last dose of nivolumab and/or ipilimumab; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
• Patients must have unresectable stage III or stage IV disease
• Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization
• Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
• Patients must have BRAFV600E or BRAFV600K mutations, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Amendments (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)
• Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a cytotoxic T-lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PD1) pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease
• Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to entering the study and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from registration and patients must be fully recovered from post-surgical complications
• Patients must not receive any other investigational agents while on study or within four weeks prior to registration
• Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks of randomization could be eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible
• Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration; patients with history of rat sarcoma (RAS) mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility
• White blood count >= 3,000/uL
• Absolute neutrophil count (ANC) >= 1,500/uL
• Platelet count >= 100,000/uL
• Hemoglobin > 9 g/dL
• Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for patients with documented liver metastases)
• Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)
• Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert's syndrome
• Serum lactate dehydrogenase (LDH) < 10 X ULN (patients with LDH > 10 X ULN are felt to have aggressive disease and should be considered for BRAF inhibitor therapy off protocol)
• Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject's safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
• Patients must not have a history of or evidence of cardiovascular risks including any of the following:
◦ QT interval corrected for heart rate using the Bazett's formula (QTcB) >= 480 msec. at baseline
◦ History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration
◦ History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
◦ Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multi gated acquisition scan (MUGA)
◦ Intra-cardiac defibrillator
◦ Abnormal cardiac valve morphology (>= grade 2) documented by ECHO (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
◦ History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible
◦ Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy
• Individuals who are known to be human immunodeficiency virus (HIV) infected are eligible (note: HIV testing is not required for entry into the study)
• Patients with evidence of active hepatitis B virus (HBV) or hepatitis C Virus (HCV) infection are not eligible; patients with cleared HBV and HCV infection will be allowed
• Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligible
• The following medications or non-drug therapies are also prohibited while on treatment in this study:
◦ Other anti-cancer therapies
◦ Other investigational drugs
◦ Patients taking any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3, subfamily A (CYP3A) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible
• Patients must not have history of retinal vein occlusion (RVO)
• Patients must not have evidence of interstitial lung disease or pneumonitis
• Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib
• STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)
• The patient must have met all eligibility criteria (except as detailed below) at the time of crossover
◦ RECIST defined measurable disease is not required
◦ Only prior systemic therapy as part of step 1 is allowed
◦ Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment
◦ History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy
◦ Patients can be less than 4 weeks from surgery or SRS to CNS metastases
◦ There is no restriction on serum LDH at crossover
◦ Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossover
• Patients must have melanoma that is metastatic and clearly progressive on prior therapy
• Patients must be at least 2 weeks and within 12 weeks from documented progressive disease (PD) on Step 1 of current study; all sites of disease must be evaluated within 4 weeks prior to registration
• Patients must have recovered from adverse events (toxicities resolved to grade 1 or less) of prior therapy; patients with immune related toxicities from ipilimumab + nivolumab may continue onto Step 2 even if still on steroids to control side effects, so long as toxicity has resolved to grade 1 or less
• Patients must have discontinued radiation therapy >= 2 weeks prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications
• Patients are ineligible if they have any currently active CNS metastases; patients who have treated brain metastases (with either surgical resection or SRS) that have been stable on head MRI or contrast CT scan for at least 4 weeks following treatment and within 4 weeks prior to Step 2 registration are eligible; patients crossing over to ipilimumab + nivolumab must not have taken any steroids =< 14 days prior to registration for the purpose of managing their brain metastases; this exclusion does not apply for patients crossing over to dabrafenib + trametinib; patients with only whole brain irradiation for treatment of CNS metastases are ineligible
• Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast

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Skin Cancer
Open to Enrollment

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

This study will evaluate two groups of patients who have melanoma that has spread from the eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to the liver, while the other group (50%) will get one of 4 standard best alternative...

Investigator:
Eric Whitman, MD

care treatments. Patients in each group will get repeating cycles of treatment until the cancer in the liver advances and will be followed until death. This study will evaluate the effect of the treatments on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

PHP-OCM-301 | PHASE III

Sponsor:
Delcath Systems, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Male or female patients ≥ 18 years of age.
2. Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
3. 50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver.
4. Disease in the liver must be measurable by computed tomography (CT) and/or magnetic resonance imaging (MRI).
5. Evidence of limited extrahepatic disease on preoperative radiological studies is acceptable if the life threatening component of PD is in the liver. Limited extrahepatic disease is defined in this protocol as follows: metastasis in up to one other organ (bone, subcutaneous, or pulmonary), limited to up to 2 nodules and amenable to resection or radiation. The extrahepatic lesions should be no larger than 2 cm in diameter each. The rationale for permitting this limited extrahepatic disease is that these types of lesions are amenable to surgical resection or radiation.
6. Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization. An MRI of the liver is required at screening to validate that CT accurately reflects the extent of disease in the liver.
7. Patients must not have chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions except those listed in Appendix B of the study protocol. Patients receiving anti programmed cell death protein 1 (PD-1) immunotherapy such as pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen 4 blocking antibody such as ipilimumab should wait 8 weeks before Melphalan/HDS treatment.
8. Patients must have an ECOG PS of 0-1 at screening and on the day prior to treatment.
9. Patients must have adequate hepatic function as evidenced by total serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and a prothrombin time (PT) within 2 seconds of the upper normal limit. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) must be ≤ 2.5 x ULN.
10. Patients must have a platelet count > 100,000/µL, hemoglobin ≥ 10.0 gm/dL, white blood cell count (WBC) > 2,000/uL, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, and a serum creatinine ≤ 1.5 mg/dL unless the measured creatinine clearance is > 40 mL/min/1.73 m2.
11. Provided signed informed consent.

Exclusion Criteria:
1. Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies.
2. Those with New York Heart Association functional classification II, III or IV active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
3. History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
4. For female patients of childbearing potential (i.e., have had a menstrual period within the past 12 months): unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment.
5. For female patients of childbearing potential (i.e. have had a menstrual period within the past 12 months): a positive serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to enrollment.
6. Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 6 months after last administration of study treatment.
7. Lactating women are excluded from study participation.
8. Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
9. Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.
10. Patients with severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids (because a hepatic angiogram is needed for the Delcath system procedure).
11. Patients with a history of or known hypersensitivity to melphalan or the components of the Melphalan/HDS system.
12. Patients with latex allergy.
13. Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
14. Patients with a history of bleeding disorders or evidence of intracranial abnormalities which would put them at risk for bleeding with anti-coagulation (e.g., strokes, active metastases).
15. Patients with a history of gastrinoma, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.
16. Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer.
17. Patients with prior Whipple's procedure.
18. Patients with brain metastases or presence of other intracranial lesions at risk for bleeding by history or baseline radiologic imaging. Active infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are exception(s).
19. Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism.
20. Received any investigational agent for any indication within 30 days prior to first treatment.
21. Not recovered from side effects of prior therapy to ≤ Grade 1 (according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade 1.

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Skin Cancer
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A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

Investigator:
Eric Whitman, MD
20120139

Sponsor:
Amgen, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial.


Inclusion Criteria:
- All subjects must provide informed consent prior to initiation of any study activities. All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial and must have permanently discontinued treatment on that trial.

Exclusion Criteria:

- Subjects currently receiving or planning to receive talimogene laherparepvec in the next 30 days.

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Skin Cancer
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A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab

This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or...

Investigator:
Eric Whitman, MD

metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).

EMR 062235-005 | PHASE II

Sponsor:
EMD Serono, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; with at least 1 lesion that can be irradiated; at least 1 measurable lesion outside the radiation field, different from the lesions that will be irradiated; 1 lesion that can be biopsied before treatment with SBRT and MSB0010445; 1 lesion outside the radiation field that can be biopsied while on treatment with MSB0010445; and the lesion that is biopsied at Baseline can be the lesion that will be irradiated
•The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or has been biopsied at Baseline
•Signed written informed consent
•Male and female subjects at least 18 years of age
•Life expectancy greater than or equal to (>=) 4 months
•Eastern cooperative oncology group (ECOG) performance status of 0 or 1
•Other protocol defined inclusion criteria could apply

Exclusion Criteria:
•Active central nervous system metastasis
•Prior treatment with systemic anti-melanoma treatment after ipilimumab treatment
•Treatment with ipilimumab within the 30 days before the first dose of SBRT
•Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
•Other protocol defined exclusion criteria could apply

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Skin Cancer
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A US Multi-Site Observational Study in Patients with Unresectable and Metastatic Melanoma: The OPTIMIzE Study

This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.

Investigator:
Eric Whitman, MD
CA209-357

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naïve or previously treated for unresectable or metastatic melanoma.

Inclusion Criteria:
Prospective cohort patients:
• Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
• Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
• Age ≥ 18 years at time of entry into study
• Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
◦ For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.
◦ For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment
Retrospective cohort patients:
• Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
• Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
• Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
◦ March 25, 2007 - March 24, 2011
• One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.
a.If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.

Exclusion Criteria:
Prospective patients:
• Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
• Patients who started new treatment > 21 days
• Patients who enrolled in study but did not initiate treatment before 28 days
• Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy

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An Open-label, Multicenter, Dose-Escalation, Phase 1B/2 Study of the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RTA 408 in Combination with Ipilimumab in the Treatment of Patients with Unresectable or Metastatic Melanoma

This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and pharmacokinetics of RTA 408 in combination with ipilimumab in patients with unresectable or metastatic melanoma.

Investigator:
Eric Whitman, MD
408-C-1401 | PHASE I/II

Sponsor:
Reata Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Be ≥18 years of age;
- Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
- Have received no prior treatment with ipilimumab;
- Have discontinued previous treatments for cancer;
- Have discontinued previous experimental therapies for a minimum of 28 days;
Be able to swallow capsules.

Exclusion Criteria:
- Have prior malignancy active within the previous 2 years;
- Have any active autoimmune disease or a history of known or suspected autoimmune disease;
- History of brain metastases that meet certain conditions;
- History of specific cardiovascular abnormalities;
- Have known active fungal, bacterial, and/or viral infection, including human immunodeficiency virus (HIV) or hepatitis virus (A,B, or C).

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Intralesional Injection (PV-10) vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma Without Distant Metastases

This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in...

Investigator:
Eric Whitman, MD

patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for at least one immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

PV-10-MM-31 | PHASE III

Sponsor:
Provectus Biopharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Age 18 years or older, male or female
- Histologically or cytologically confirmed melanoma
- Stage IIIB or IIIC recurrent, satellite or in-transit cutaneous or subcutaneous melanoma
- At least 1 cutaneous Target Lesion > =10 mm in longest diameter. Target Lesions should be at least 10 mm from any other lesion
- No lesion > 30 mm in longest diameter; and no more than 20 lesions
- Calculated required PV-10 dose ≤ 15 mL (based on total tumor burden)
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Failed, did not tolerate, or not a candidate for (due to co-morbidities, pre-existing autoimmune disease or drug unavailability) treatment with ipilimumab or another immune checkpoint inhibitor
- Not a candidate for treatment with vemurafenib, dabrafenib or trametinib (i.e., BRAF V600 wild-type)
- Life Expectancy: At least 6 months.

Clinical Laboratories:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥100 x 10^9/L
- Creatinine ≤ 3 times the upper limit of normal (ULN)
- Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
- Total bilirubin ≤ 3 times the upper limit of normal (ULN)
- Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal (ULN)
- Lactate dehydrogenase (LDH) ≤ 2 times the upper limit of normal (ULN).
- Thyroid function abnormality ≤ Grade 2

Exclusion Criteria:

- Presence or history of visceral or distant cutaneous or subcutaneous melanoma metastasis
- Presence of active nodal metastasis
- Presence of more than 20 melanoma lesions
- Radiation therapy to any Study Lesion within 4 weeks of initial study treatment.
- Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
- Immunotherapy for cancer within 4 weeks of initial study treatment
- Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
- Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
- Investigational agents within 4 weeks (or 5 half-lives) of initial study treatment.

Concurrent or Intercurrent Illness:
- Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
- Severe peripheral vascular disease in subjects whose Study Lesions are located in an extremity
- Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.
- Uncontrolled thyroid disease or cystic fibrosis
- Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders

Pregnancy:
- Female subjects who are pregnant or lactating
- Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
- Female subjects of child-bearing potential who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures)

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Skin Cancer

Phase Ib Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Ipilimumab in Patients With Advanced Melanoma

The study will use the established dose of CAVATAK with ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. Treatment with CAVATAK will be on days 1, 3, 5 and 8 and then both agents will be co-administered...

Investigator:
Eric Whitman, MD

on days 22, 43, 64 and 85. Patients with clinical benefit can continue CAVATAK every 3 weeks for up to one year,

VLA-013 | PHASE I

Sponsor:
Viralytics Limited

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients with metastatic or unresectable stage IIIc or IV melanoma for whom treatment with ipilimumab is indicated
• At least one tumor must qualify to be a target lesion for irRC-WHO
• ECOG of 0-1
• Women of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hour prior to the start of treatment
• No active bleeding
• Life expectancy > 12 weeks

Exclusion Criteria:
• Prior ipilimumab treatment for metastatic melanoma (prior ipilimumab as adjuvant permitted if no ≥ grade 3 toxicity)
• Tumors to be injected lying in mucosal regions or close to airway, major blood vessel or spinal cord that could cause occlusion or compression due to tumor swelling or erosion
• Active autoimmune disease (excluding autoimmune thyroiditis or vitiligo)
• Patients with history of colitis
• Untreated brain metastases.
• Other active metastatic cancer requiring treatment
• Active infection requiring antibiotics
• Pregnant or lactating women
• Need for chronic steroids
• Within 28 days of enrollment: WBC < 3.1 x 10⁹ /L; Hgb < 9.0 g/dL; AST or ALT > 1.5 upper limit of normal (ULN); total bilirubin > 1.9 g/dL; prior HIV; prior Hepatitis B; prior Hepatitis C; INR > 1.5 x ULN

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