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 Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

Summary: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.


Eligibility: Inclusion Criteria:
  -  Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcoma mutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); or Part C: metastatic breast cancer (HR+, HER2-).
  -  Part A: must be chemotherapy naïve for metastatic NSCLC
  -  Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC
  -  Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
  -  Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).
  -  Have presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  -  Have a performance status (PS) ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
  -  Have an estimated life expectancy of ≥12 weeks.
  Exclusion Criteria:
  -  Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.
  -  Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug.
  -  Have corrected QT interval of >470 milliseconds on screening electrocardiogram (ECG).
  -  Have history of interstitial lung disease or pneumonitis.
  -  Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.
  -  Have received a live vaccination within 30 days of study start.
  -  Have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.

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: 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: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy

Summary: Objective:
  To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.
  In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.

Detailed description: Primary end-point:
  Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.
  Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:
  1. There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
  2. There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.

Eligibility: Inclusion Criteria:
  -  Men suitable for monotherapy with permanent Iodine 125 implant
  -  Age > 50 yrs
  -  PS 0-2 (WHO)
  -  Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken
  -  No more than 50% of cores involved (summary)
  -  MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result
  -  Gleason sum no greater than 3+4 =7 in any core
  -  Clinical T stage no higher than T T (tumor) 2A
  -  Prostate volume ≤60 cc
  -  Serum prostate-specific antigen (PSA) no higher than 15 ng/mL
  -  No prior history of malignancy except non-melanoma skin cancer
  -  Must be suitable for general or spinal anesthesia
  Exclusion Criteria:
  Have anesthesia surgical assignment category IV or greater
  -  Cannot cease anti-coagulant therapy
  -  Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
  -  urethral stricture
  -  Prior prostate cancer therapies

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: Interferon Toxicities in Melanoma Treatment

Summary: The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.


Eligibility: Inclusion Criteria:
  -  Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
  -  Patients with a melanoma diagnosis based on two medical claims prior to the index date
  -  Patients with a procedure code for melanoma-related lymph node dissection before the index date
  -  Patients ≥ 18 years of age on or before the index date
  -  Patients with continuous benefit enrollment for at least 180 days before and after the index date
  Exclusion Criteria:
  -  Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
  -  Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
  -  Patients who received systemic chemotherapy during the pre- or post-index period

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

Clinical trial: A Phase 1 Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Summary: This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion.


Eligibility: Partial Inclusion Criteria:
  -  Patient with advanced or metastatic solid tumor and has disease progression or treatment intolerance after treatment with available therapies
  -  Agreement to biopsies before and during treatment, depending on study part
  -  Female patients must have a negative serum pregnancy test or be of non-childbearing potential.
  -  Two methods of contraception required for males and females of childbearing potential
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 and adequate organ function
  Partial Exclusion Criteria:
  -  Received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent within 8 weeks prior to initiation of study treatment depending on study part
  -  Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis or known malignancy that progressed or required active treatment within the last 2 years
  -  Pregnant, breastfeeding, or expecting to conceive children within projected duration of study
  -  History of human immunodeficiency virus (HIV), interstitial lung disease, active Hepatitis B or Hepatitis C
  -  Autoimmune disease that required systemic treatment in past 2 years
  -  Not recovered from radiation and chemotherapy-induced AEs or received blood transfusion
  -  Participated in another investigational study (drug or device) within 4 weeks of first dose
  -  Received prior anticancer therapy within 21 days of first dose
  -  Not recovered from AEs and/or complications from major surgery prior to first dose
  -  Received a vaccine within 7 days of first dose

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

Clinical trial: PD-1 Knockout Engineered T Cells for Castration Resistant Prostate Cancer

Summary: This study will evaluate the safety of PD-1 knockout engineered T cells in treating castration resistant prostate cancer (CRPC). Blood samples will also be collected for research purposes.

Detailed description: This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility: Inclusion Criteria:
  -  Pathologically and clinical verified castration resistant prostate cancer with measurable lesions (On CT: longest diameter of tumoral lesion >=10 mm, shorted diameter of lymph node >=15 mm; measurable lesions should not have been irradiated)
  -  Progressed after all standard treatment
  -  Performance score: 0-1
  -  Expected life span: >= 6 months
  -  Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
  -  Major organs function normally
  -  Willing and able to provide informed consent
  Exclusion Criteria:
  -  Pathology is mixed type
  -  Emergent treatment of tumor emergency is needed
  -  Poor vasculature
  -  Coagulopathy, or ongoing thrombolytics and/or anticoagulation
  -  Blood-borne infectious disease, e.g. hepatitis B
  -  History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
  -  With other immune diseases, or chronic use of immunosuppressants or steroids
  -  Compliance cannot be expected
  -  Other conditions requiring exclusion deemed by physician

Relevance to patient case: not relevant