araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma

Summary: The study design includes an open-label, dose escalation phase followed by a blinded, randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved therapy and compares to approved therapy plus placebo in metastatic melanoma patients.


Eligibility: Inclusion Criteria:
  -  Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
  -  A life expectancy of >12 weeks.
  -  Laboratory ranges and medical criteria met, as defined within the protocol.
  -  Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
  -  For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.
  Exclusion Criteria:
  -  Pregnant or nursing women.
  -  Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
  -  Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
  -  Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-PD-1, anti- PD-L1 and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
  -  Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
  -  Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.


Eligibility: Inclusion Criteria:
  -  patients more than 18 years old,
  -  consulting their GP,
  -  assessed at risk for melanoma according to the SAMScore
  -  signed the consent.

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

Summary: The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Men & women ≥ 18 years of age
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  -  Histologically confirmed Stage III (unresectable)/Stage IV melanoma
  -  Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  -  Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
  -  Pre-treatment fresh core, excision or punch tumor biopsy
  -  Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
  Exclusion Criteria:
  -  Any treatment in a BMS-936558 (Nivolumab) trial
  -  Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
  -  Active, known or suspected autoimmune disease
  -  Unknown BRAF status
  -  Active brain metastasis or leptomeningeal metastasis
  -  Ocular melanoma
  -  Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)

Relevance to patient case: definitely relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

Summary: The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Men and women ≥18 years of age
  -  Eastern Cooperative Oncology Group Performance Status of 0 or 1
  -  Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
  -  Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
  -  Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
  -  Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize
  Exclusion Criteria:
  -  Active brain metastases or leptomeningeal metastases
  -  Ocular melanoma
  -  Any active, known, or suspected autoimmune disease

Relevance to patient case: definitely relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Summary: To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Detailed description: To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Eligibility: Inclusion Criteria:
  1. Older than 18 years and younger than 80 years of age.
  2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
  3. The only treatment for melanoma is surgical treatment.
  4. Complete resection of melanoma.
  5. Single primary invasive cutaneous melanoma
  6. Signed ethical committee approved informed consent
  7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference
  Exclusion criteria
  1. Pregnant/lactating women or planning on becoming pregnant during the study
  2. Known hypersensitivity to vitamin D or its components.
  3. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
  4. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
  5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
  6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
  7. History of small intestine resection.
  8. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
  9. Chronic alcohol abuse.
  10. Medical or logistic problems likely to preclude completion of the study.
  11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
  12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Clinical and Histopathologic Characteristics of BAP1 Mutations

Summary: The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.


Eligibility: Inclusion Criteria:
  All consents:
  -  > or = to 18 years of age
  -  Ability to provide informed consent
  Consent 1:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  Consent 2:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Age<50 at diagnosis
  -  No history of asbestos exposure
  -  Personal history of choroidal nevus, uveal melanoma, melanoma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography AND one of the following:
  -  More than one clinical risk factor, which may include: orange pigment, thickness > 1 < 2.5mm
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  AND one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Metastatic uveal melanoma
  -  Histologically proven diagnosis of metastatic uveal melanoma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives
  Consent 3:
  -  Relative of patient with germline BAP1 mutation identified through identified testing
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: In Vivo Real-time Detection of Circulating Melanoma Cells

Summary: The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.

Detailed description: Study Population: Approximately 80 subjects will be consented in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts as follows:
  1. Cohort #1 will consist of fifteen healthy control subjects, ten of whom will be Caucasian and five of whom will be African-American. Subjects in cohort #1 will be used to address the calibration goal of Specific Aim #1.
  2. Cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be recruited from the Medical Oncology clinic at UAMS, where advanced stages are defined as Stages III or IV. Subjects in cohort #2 will be used to address the validation goal of Specific Aim #2. Approximately half of the 30 advanced-stage subjects will be Stage III and the other half will be Stage IV.
  3. Cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from the Surgical Oncology clinic at UAMS, where early stages are defined as Stages I or II.
  Subjects in cohort #3 will be used to address the detection goal of Specific Aim #3. Approximately 10 of the 30 early-stage subjects will be Stage I and approximately 20 will be Stage II.

Eligibility: Inclusion Criteria:
  -  Age 18 to 80 years
  -  Histological documented diagnosis of melanoma
  -  Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)
  -  Must be able to sit still for 90 minutes
  Exclusion Criteria:
  -  Active infection
  -  Current and significant medical or surgical condition as determined by the Investigator
  -  Diagnosis or evidence of organic brain syndrome
  -  Pregnancy or breastfeeding

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)

Summary: The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab

Detailed description: In order to evaluate the potential synergistic activity of nivolumab and ipilimumab and also because there may be differences in biology between tumors which are stable or responding to therapy and those that are clinically progressing, this study, CA209064, looked at two sequential combination regimens in which the second agent is administered immediately after a pre-specified duration of therapy with the first agent and not delayed until the time of progression after the first agent. This sequential study design looked at pharmacodynamic changes during treatment with one agent which may predict clinical activity to subsequent treatment with the alternate agent. This was done because it has not been scientifically proven whether or not the order in which nivolumab and ipilimumab are given is clinically important.

Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Histologically confirmed unresectable Stage III or IV melanoma
  -  Treatment-naive or experienced disease recurrence or progression during or after one prior systemic regimen for advanced disease
  -  Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Known BRAF V600 mutation status or consent to BRAF V600 mutation testing
  -  Sufficient tumor tissue accessible for baseline and post-treatment biopsies.
  Exclusion Criteria:
  -  Active central nervous system (CNS) metastases
  -  Carcinomatous meningitis
  -  Active, known or suspected autoimmune disease
  -  Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
  -  Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4) antibody
  -  Prior treatment with other immunotherapies
  -  Prior therapy with BRAF inhibitor within 6 weeks of enrollment

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls

Summary: In previous work, the investigators analyzed the concentration of gut-derived peptides (ghrelin, pancreatic polypeptide [PP]) in serum of patients with Parkinson's disease (PD). The investigators have shown that the secretion pattern differs between PD patients and controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g. Glucagon-like-Peptide 1[GLP-1], Amylin, etc.) might be relevant for PD as well. The rational to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is based on the following considerations:
  -  Receptors for gut-derived peptides are expressed in Central Nervous System (CNS) structures that are affected by the neurodegenerative process underlying Parkinson's disease
  -  Gut-derived peptides are involved in the modulation of higher brain functions (mood, cognition, reward-related behaviour) that are frequently altered in Parkinson's disease.
  -  The secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional in Parkinson's disease.
  -  Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able to prevent cell death in neurodegenerative disorders, including Parkinson's disease.
  Objective:
  Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions:
  1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls?
  2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?


Eligibility: Main Inclusion Criteria:
  -  Informed consent to participate
  -  Capability to understand risks of study-related procedures
  -  For PD cohort: diagnosis of (idiopathic) Parkinson's disease
  Main Exclusion Criteria:
  -  Pregnancy
  -  Subjects incompetent to provide informed consent
  -  Subjects that cannot undergo a lumbar puncture for medical reasons (thrombocytopenia, anticoagulation, increased cranial pressure)
  -  For control cohort: presence of a neurodegenerative disorder

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma

Summary: In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).


Eligibility: Inclusion Criteria:
  -  Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.
  Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.
  Exclusion Criteria:
  -  Patients with symptomatic brain metastases and Performans Status (PS)>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.

Relevance to patient case: not relevant
Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Histologically confirmed stage III (unresectable) or stage IV melanoma
  -  Treatment naïve patients
  -  Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
  -  Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  Exclusion Criteria:
  -  Active brain metastases or leptomeningeal metastases
  -  Ocular melanoma
  -  Subjects with active, known or suspected autoimmune disease
  -  Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
  -  Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

Relevance to patient case: definitely relevant