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: Clinical Research for the Consistency Analysis of PD-L1 in Lung Cancer Tissue and Plasma Exosome Before and After Radiotherapy

Summary: The detection of tissue PD-L1 immunohistochemistry in NSCLC has an important role in guiding for the treatment of immune detection point.Radiation therapy can enhance the effect of immunotherapy,but radiation dose and timing are waiting to be solved. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in tissues and pExo before and after radiotherapy.We have designed five kinds of radiation-division with bioequivalent doses, and detected the expression levels of PD-L1 in pExo after 24h, 48h of each stage of radiotherapy.PD-L1 mRNA levels in pExo detected at different time points,by using variance analysis of repeated measures design information.Probing the best timing and manner of radiotherapy division which can make PD-L1 express more,guiding clinical practice of radiotherapy combining with immunotherapy.


Eligibility: Inclusion Criteria:
  1. Pathological histology and/or cytology confirmed NSCLC;
  2. Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC;
  3. PS 0-2;
  4. Expected survival > 3 months;
  5. Age 18~75 years old;
  6. The function of lung, liver, kidney, bone marrow was normal;
  7. The patients had not received radiotherapy for previous primary tumor and metastases;
  8. At least accept 2−4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy;
  9. Wild-type EGFR;
  10. Sensitive mutant EGFR, but refused to targeted therapy;
  11. In line with the indications of radiotherapy and accept it;
  12. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
  Exclusion Criteria:
  1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
  2. Patients with other malignancies;
  3. Patients with a history of autoimmune disease;
  4. The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test);
  5. In the activity of acute or chronic infectious diseases;
  6. Patients with a clear history of drug allergy or allergic genus;
  7. Patients with participating in other clinical trials at the same time;
  8. Other cases that researchers believe that patients should not participate in the present trial.

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 Histological Features of Head and Neck Melanoma

Summary: The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

Detailed description: Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Eligibility: Inclusion Criteria:
  -  patients with melanoma
  -  melanoma diagnosed between January 2004 and December 2011
  -  patients living in Champagne-Ardenne

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 Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome

Summary: The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.


Eligibility: Inclusion Criteria:
  1. Pathological histology and/or cytology confirmed malignant tumor;
  2. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
  Exclusion Criteria:
  1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
  2. Patients with a history of autoimmune disease;
  3. Patients with participating in other clinical trials at the same time;
  4. Other cases that researchers believe that patients should not participate in the present trial.

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 I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

Summary: To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.


Eligibility: Inclusion Criteria:
  1. Written informed consent must be obtained prior to any screening procedures.
  2. Patient (male or female) ≥ 18 years of age.
  3. Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
  4. Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic, prostate and ccRCC.
  5. ECOG Performance Status ≤ 2.
  6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.
  Exclusion Criteria:
  1. History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug.
  2. Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  3. HIV infection.
  4. Active HBV or HCV infection.
  Other protocol-defined inclusion/exclusion criteria may apply.

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 of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma


Eligibility: Inclusion criteria Part 1: Safety run-in
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
  -  ECOG performance status ≤ 1
  Part 2: Biomarker cohort
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
  -  ECOG performance status ≤ 2
  Part 3: Double-blind, randomized, placebo-controlled part
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  Part 1: Safety run-in
  -  Subjects with uveal or mucosal melanoma
  -  Any history of CNS metastases
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
  -  Subjects with uveal or mucosal melanoma
  -  Clinically active cerebral melanoma metastasis
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Other protocol-defined Inclusion/Exclusion may apply.

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: Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma

Summary: This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.

Detailed description: PRIMARY OBJECTIVES:
  I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.
  II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.
  SECONDARY OBJECTIVES:
  I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.
  OUTLINE:
  Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB).
  After completion of study treatment, patients are followed up at 24 and 48 hours.

Eligibility: Inclusion Criteria:
  -  Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression
  -  Mitotic rate >= 1/mm^2
  -  Presence of angiolymphatic invasion
  -  Deep positive margin
  -  No known allergies to contrast material
  Exclusion Criteria:
  -  Pregnant or nursing
  -  Patients with known cardiac shunt
  -  Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
  -  Patients who have experienced an acute coronary syndrome or angina in the past 6 months
  -  Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years
  -  Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram
  -  Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram
  -  Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification
  -  Patients with hypersensitivity to sonazoid or one of its components
  -  Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)
  -  Patients who cannot consent for themselves

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: 99m-Tc Labeled Anti-PD-L1 VHH for Diagnostic Imaging of Non-Small Cell Lung Cancer

Summary: To evaluate the efficacy and safety of 99m-Tc labeled anti-PD-L1 VHH for SPECT/CT diagnostic imaging of Non-Small Cell Lung Cancer and compare it with the existing gold standard "biopsy PD-L1 detection". It is also to establish a new method of clinical diagnosis of NSCLC using 99m-Tc labeled anti-PD-L1 VHH.


Eligibility: Inclusion Criteria:
  -  Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
  -  Male or female, aged 18-75 years old
  -  Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests
  -  AST, ALT, BUN, Cr not more than double the normal values
  -  Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases
  Exclusion Criteria:
  -  Severe infection
  -  PD-L1 expression level undetermined
  -  Patients with pacemakers
  -  Pregnant and lactating women
  -  Investigators professional decision that the subject should not participate in this clinical 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: Real-Life Efficacy and Safety of Nivolumab Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma

Summary: Real-Life Efficacy and Safety of Nivolumab monotherapy or in combination with Ipilimumab in Patients with Advanced (Unresectable or Metastatic) Melanoma


Eligibility: Inclusion Criteria:
  -  ≥ 18 years
  -  advanced melanoma (Stage III/Stage IV)
  -  histologically confirmed diagnosis
  -  treatment decision for nivolumab mono- or combination therapy already taken
  -  signed informed consent
  Exclusion Criteria:
  -  current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment
  -  previous treatment with nivolumab
  -  current active participation in an interventional clinical trial for treatment of advanced melanoma

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: An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

Summary: This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of stage III (unresectable) or stage IV melanoma with at least 1 lesion that is measurable by RECIST 1.1 criteria and accessible for biopsies
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  -  Adequate hepatic function
  -  Adequate renal function
  -  Adequate bone marrow function
  -  Willing and able to comply with clinic visits and study-related procedures
  -  Provide signed informed consent
  -  Able to understand and complete study-related questionnaires
  -  Anticipated life expectancy >12 week
  Exclusion Criteria:
  -  Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
  -  Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway)
  -  Prior treatment with other immune modulating anti-cancer agents, except for remote treatment (>6 months) in adjuvant setting.
  -  Untreated brain metastasis(es) that may be considered active.
  -  Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
  Other protocol-defined inclusion/exclusion criteria will apply

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: PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients

Summary: The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.

Detailed description: Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients.
  explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.

Eligibility: Inclusion Criteria:
  1. The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
  2. The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
  3. Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening.
  4. Fine needle aspirate specimens are not acceptable.
  5. Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
  6. The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred in formalin-fixed paraffin embedded blocks.
  Exclusion Criteria:
  1. The patient does not have sufficient tumor tissue specimen available for detection.
  2. The Patient who is unwilling to use the existing data from medical practice for scientific research.
  3. The patient who received immunotherapy therapy before.

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 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma

Summary: This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Detailed description: After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Eligibility: Inclusion Criteria:
  -  Biopsy proven T2 malignant melanoma.
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-2.
  Exclusion Criteria:
  -  Visible additional disease that suggests a greater than T2 malignant melanoma
  -  Unable to tolerate general anesthesia
  -  Evidence of distant metastatic disease
  -  Melanoma located on face or digits

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: Asia PDL1 Study Among NSCLC Patients

Summary: MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression and to assess the clinical characteristics and outcomes among NSCLC patients

Detailed description: MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression among NSCLC patients and to assess the clinical characteristics and outcomes of these patients with specific attention to EGFR, ALK, and KRAS mutations. The study will determine whether PD-L1 is a prognostic factor in the Asia-Pacific patient population; The study will enrol NSCLC patients with disease diagnosis between January 2010 and December 2014; The patients will be recruited from Asia-Pacific, potentially China, Japan, and South Korea. A total of approximately 750 patients will be enrolled in the study; around 250 NSCLC patients will be enrolled per country.

Eligibility: Inclusion Criteria:
  1. Adult male or female (according to age of majority as defined in local regulations).
  2. NSCLC diagnosis between 01 January 2010 and 31 December 2014.
  3. FFPET collected via core needle biopsy or resection and available in sufficient amount to complete PD-L1 testing.
  4. FFPET tissue samples collected for NSCLC original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date.
  5. Patients with locally advanced or metastatic NSCLC who have initiated 1st line palliative chemotherapy by 31 December 2014.
  Exclusion Criteria:
  1. Patients with locally advanced NSCLC with resectable disease and treated with curative intent.

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 1B Study in Subjects With Small to Medium Primary Choroidal Melanoma

Summary: The primary objective is to assess the safety, immunogenicity and preliminary efficacy of a single treatment of one of two dose levels of Light-activated AU-011 for the treatment of subjects with primary choroidal melanoma.

Detailed description: This is a phase 1B open-label, single ascending dose clinical trial designed to evaluate the safety of two dose levels of Light-activated AU-011 for the treatment of subjects with small to medium primary choroidal melanoma.
  Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

Eligibility: Inclusion Criteria:
  -  Diagnosis of uveal melanoma
  Exclusion Criteria:
  -  Have known contraindications or sensitivities to the study drug

Relevance to patient case: not relevant