araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy

Summary: Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer.
  Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with clinical markers of response. PET/CT tumor metabolic response will also be correlated will to progression-free survival and overall survival.


Eligibility: Inclusion Criteria:
  -  Adult patients, at least 18 years of age
  -  Histologically confirmed non-small cell lung cancer or malignancy pleural mesothelioma with at least one site of disease > 1 cm by at least one type of standard imaging (e.g.
  CT, chest x-ray, MRI)
  -  Recommended to start anti-PD1/PDL1 therapy.
  -  Obtaining pre-PD1/PDL1 therapy clinical re-staging [18F]FDG-PET/CT scan at the Hospital of the University of Pennsylvania.
  -  Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
  -  Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.
  Exclusion Criteria
  -  Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
  -  Patients with only a single site of primary non-small cell lung cancer or malignancy pleural mesothelioma who have undergone or are recommended to undergo radiation therapy to that site will not be eligible, the inclusion of patients who may be undergoing radiation therapy to ancillary disease sites may be allowed to enter the study at the discretion of the PI if it is not felt to affect the ability to capture [18F]FDG information for at least one primary site of disease.
  -  Patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
  -  Patients who have received prior immunotherapy.
  -  Patients with an active auto-immune disease (ie. Multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, vasculitis).
  -  Inability to tolerate imaging procedures in the opinion of the investigator or treating physician
  -  Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
  -  Unwilling or unable to provide informed consent

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

Summary: This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Detailed description: This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Eligibility: Inclusion Criteria
  1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  2. Documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability (MSI), and bladder cancer.
  3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  4. At least 1 but not more than 5 prior systemic therapies for advanced/recurrent or progressing disease.
  Exclusion Criteria
  1. History of severe hypersensitivity reaction to monoclonal antibodies.
  2. Any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy.
  3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis.
  4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
  5. If a patient is currently receiving denosumab, this must be discontinued prior to enrollment. Substitution with biphosphonates are acceptable.

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Employment and Quality of Life in Patients With Malignant Melanoma

Summary: Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma


Eligibility: Inclusion Criteria:
  -  first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
  -  written informed consent
  Exclusion Criteria:
  -  diagnosis of malignant melanoma stage IV
  -  inability to follow the protocol

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Phase I Study of PDR001 in Patients With Advanced Malignancies.

Summary: The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.


Eligibility: Inclusion Criteria:
  -  Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
  -  ECOG Performance Status ≤ 2
  Exclusion Criteria:
  -  Active autoimmune disease
  -  Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  -  Prior PD-1- or PD-L1-directed therapy
  Other protocol defined inclusion/exclusion may apply.

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

Summary: As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.


Eligibility: Inclusion Criteria:
  1. Male patients;
  2. 18 yrs and older, and 80 yrs and younger;
  3. Histologically or cytologically proven prostate adenocarcinoma;
  4. Imaging examinations including Emission Computed Tomography (ECT),Positron Emission Tomography (PET),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
  5. Not yet receiving hormonal therapy;
  6. Not yet receiving chemotherapy previously;
  7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
  8. Patients are willing to participate and can be followed up regularly；
  Exclusion Criteria:
  1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
  2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
  3. Patients received chemotherapy previously;
  4. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Study Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary: The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
  -  No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
  -  Measurable disease detected by imaging exam (CT or MRI).
  -  Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.
  Exclusion Criteria:
  -  Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
  -  No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
  -  Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
  -  Inadequate hematologic, renal or hepatic function.
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: The ED50 of DEX for Providing Sedation in Different Female Age Group

Summary: Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age, and current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.

Detailed description: 90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.

Eligibility: Inclusion Criteria:
  1. ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.0～25.0kg/m2
  Exclusion Criteria:
  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. People who were language or hearing impaired
  5. Sensory block reached to T8 or higher.
  6. People who had lung infection or sleep apnea syndrome.
  7. Pregnancy
  8. Chronic renal failure
  9. Alcohol or drug abuse
  10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Epidemiologic Multicenter Prospective Study in Advanced NSCLC (Non Small Cell Lung Cancer) Patients With PDL1 (Protein Death Ligand 1) Expression.

Summary: Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression : evaluation of clinical and pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

Detailed description: Few data are published on the clinical and pathological characteristics of advanced NSCLC with high PDL1 expression compare to weak and no expression populations.
  There is not for the moment a standard test to determine a relevant target population. Preliminary data showed that around 25% of the NSCLC population may have a high PDL1 expression and may have a greater benefit of anti PDL1 therapy. But in fact limited data have been published in European populations on the clinical and pathological characteristics (high PDL1 expression) compared to the weak expression and no expression populations. More over the prognosis rule of a high PDL1 expression in NSCLC is not definitive, with some studies indicating it is a positive prognostic factor while other studies showing that it is a negative prognostic factor.
  To understand if there are differences in terms of prognostic between advanced NSCLC with high and low/no expression of PDL1 is a major challenge for the future management strategy of these patients. The results of this study should helps to elaborate new guidelines for this population. Therefore is also important to had data's on the natural course of the disease in these population for building cost effectiveness models of new immune therapies.

Eligibility: Inclusion Criteria:
  -  Patients aged 18 years or more
  -  With locally advanced stage (IIIb) to stage IV NSCLC - Non Small Cell Lung Cancer -
  -  Histological diagnostic :
  -  No known Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) / Reactive Oxygen Species (ROS) translocation
  -  At least 2 slides of tumoral sample available
  -  No previous chemotherapy treatment. Neo or adjuvant therapy is allowed if done at least one year before inclusion
  -  Performance Status ( PS) 0/1
  Planned to receive a platin based standard treatment (cisplatin or carboplatin with bevacizumab (restricted to no squamous) pemetrexed(restricted to no squamous) , gemcitabine, vinorelbine, docetaxel or taxol, on first line setting, in standard dose
  • A RECIST - Response Evaluation Criteria In Solid Tumor - target lesion
  Exclusion Criteria:
  -  Age fewer than 18
  -  Pregnancy
  -  Known immune deficit
  -  PS > 1
  -  Inclusion in a clinical therapeutic trial in first line
  -  Patient treated with Protein D1/Protein Death Ligang1 (PD1/PDL1) therapy on first line setting.

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

Summary: Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.
  This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.
  Patients eligible for this study may have previously received treatment with a checkpoint inhibitor.

Detailed description: The treatment regimen will begin with a 7-Day Lead-in Period of mocetinostat alone followed by start of the combination regimen of mocetinostat and durvalumab. The Recommended Phase 2 Dose of mocetinostat will be established in the Phase 1 dose escalation segment, followed by evaluation of the clinical activity of the combination regimen in Phase 2.

Eligibility: Inclusion Criteria:
  -  Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
  -  Not amenable to treatment with curative intent
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  Impaired heart function
  -  Uncontrolled tumor in the brain
  -  Other active cancer

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas

Summary: CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.


Eligibility: Inclusion Criteria:
  1. Males and females ≥ 18 years of age;
  2. Life expectancy of at least 3 months;
  3. ECOG PS ≤ 1;
  4. Acceptable bone marrow and organ function at screening;
  5. Ability to swallow and retain oral medications;
  6. Negative serum pregnancy test in women of childbearing potential;
  7. Measurable disease;
  8. Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective.
  Exclusion Criteria:
  1. Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
  2. Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
  3. Radiotherapy within the last 21 days;
  4. Primary brain tumors or CNS metastases;
  5. Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
  6. Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
  7. Active infection requiring systemic therapy;
  8. Receipt of vaccines against infectious diseases within 28 days;
  9. HIV positive or an AIDS-related illness;
  10. Active/chronic HBV or HCV infection;
  11. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
  12. Cardiac dysrhythmias;
  13. Gastrointestinal disease that interferes with receipt of oral drugs;
  14. Concomitant malignancy;
  15. Pregnant or lactating female;

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: PDL-1 Expression on Circulating Tumor Cells in Non-small Cell Lung Cancer

Summary: Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials with recently published positive results leading to the approval of one drug in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1) expression by tumor cells is strongly associated with the response to such molecules so that the participation in various clinical trials is currently reserved for patients expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided) representing a considerable drag on the access to these treatments. Circulating tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive access to the tumor. It has already been demonstrated that molecular characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry.
  Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated to the response to these drugs.
  The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1 expression on CTC


Eligibility: Inclusion Criteria:
  -  Stage IV non-small cell lung cancer patient prior to start immunotherapy treatment
  -  Patients with World Health Organization (WHO) performance status 0-3
  -  Patients who were informed and had non opposition form signed by investigator
  -  Patients with healthcare insurance system affiliation
  Exclusion Criteria:
  -  Prior malignancy within 5 years of study entry
  -  Refusal to participate
  -  Patient under legal protection

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma

Summary: This research trial studies the levels of a type of biomarker, circulating tumor cells (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Studying samples of blood in the laboratory obtained before and after treatment from patients with melanoma may help doctors learn more about changes that occur in CTC levels and whether they may predict how well patients will respond to therapy.


Eligibility: Inclusion Criteria:
  -  Subjects must have signed tissue collection consent as described in protocol IRB# 703001,UPCC# 08607, PI: Giorgos Karakousis, MD
  -  Subjects must be competent to consent for themselves.
  -  Subjectsmust be adult (18 years or older).
  -  Subjects must be initiating a new therapy for melanoma (so a pretreatment CTC count can be obtained).
  Exclusion Criteria:
  -  Children (less than 18yrs)
  -  Patients in whom a pre-treatment CTC level cannot be obtained.

Relevance to patient case: not relevant