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: Combination of Anti-PD-L1 and NK Immunotherapy for Recurrent Solid Tumors

Summary: The aim of this study is the safety and efficacy of anti-PD-L1 plus NK immunotherapy to multiple solid tumors.

Detailed description: By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-L1 and natural killer (NK) cells.
  The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility: Inclusion Criteria:
  -  All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  -  Body tumor 1-6, the maximum tumor length < 5 cm
  -  KPS ≥ 70, lifespan > 6 months
  -  Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
  Exclusion Criteria:
  -  Patients with cardiac pacemaker
  -  Patients with brain metastasis
  -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

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: Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)

Summary: Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

Detailed description: The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.
  The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.

Eligibility: Inclusion Criteria:
  1. Aged 18 years old or more
  2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
  3. No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
  4. Patient able to stand a blood collection.
  5. Patient explanation given and consent information signed or by legal representative.
  Exclusion Criteria:
  6. Patient without social protection / insurance..
  7. Patient with hepatic metastasis unresectable by surgery
  8. Patient with extra-hepatic metastasis.
  9. Person deprived of liberty or under guardianship
  10. Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

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: Progesterone Induced Blocking Factor Expression Levels in Endometrial Cancer Cells.

Summary: Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be questionable whether tumor cells express PIBF for escape of immune system. There are some studies in the literature that evaluate PIBF expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF expression levels in the endometrial cancer cells.

Detailed description: This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. There are three groups in this study; endometrial cancer, endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided form the Pathology clinic of Kayseri Training and Research Hospital archives.

Eligibility: Inclusion Criteria:
  -  diagnosed endometrial cancer
  -  diagnosed endometrial hyperplasia
  Exclusion Criteria:
  -  diagnosed cancer except endometrial 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: Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Summary: Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
  In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

Detailed description: The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
  The secondary objectives of this study will be:
  -  Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
  -  Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Eligibility: Inclusion Criteria:
  -  patient with melanoma confirmed histologically
  -  patient with metastatic melanoma (stage III unresectable or stage IV)
  -  patient consenting to participate to the study
  -  patient enrolled in the national healthcare insurance program
  -  patient older than 18 years
  Exclusion Criteria:
  - Metastatic tumor whose origin is doubtful (uncertain melanoma)

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: 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Circulating Tumor Material in Colorectal Cancer and Melanoma

Summary: Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma


Eligibility: Inclusion Criteria:
  -  The subject must be a patient at the Hospital of the University of Pennsylvania
  1. Patients with presumed stage II, III, or IV colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the Hospital of the University of Pennsylvania
  2. Patients with histologically confirmed melanoma stage IIb, IIc, IIIa, IIIb, or IIIc/IV scheduled for surgical resection being evaluated at the Hospital of the University of Pennsylvania.
  -  The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
  -  The subject must be 18 years of age or older.
  Exclusion Criteria:
  -  The subject is not able 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: 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: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: A Study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer

Summary: This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1-high expression

Detailed description: Patients will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The Co-primary objectives of this study are to assess the efficacy of durvalumab compared to SoC in terms of PFS (Progression Free Survival) and OS (Overall Survival) in patients with NSCLC

Eligibility: Inclusion Criteria
  -  Aged at least 18 years
  -  Documented evidence of Stage IV NSCLC
  -  No sensitizing EGFR mutation and ALK rearrangement
  -  PD-L1 expression at least 25%
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion Criteria:
  -  Prior chemotherapy or any other systemic therapy for advanced NSCLC
  -  Prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic T- lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
  -  Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment
  -  Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
  -  Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease]

Relevance to patient case: not relevant