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: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Summary: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)

Detailed description: The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.

Eligibility: Inclusion Criteria:
  1. Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose.
  2. Patients must be > 15 years of age and must have metastatic melanoma.
  3. Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery.
  4. Patients must be able to understand and sign the Informed Consent document.
  5. Patients must be able to complete the supplemental data form
  Exclusion Criteria:
  1. women who are pregnant or breastfeeding
  2. inability to give 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: Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

Summary: The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.
  The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  -  Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  -  16 Years and older
  Exclusion Criteria:
  -  Less than 16 Years of age

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 on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy

Summary: To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients.
  72 patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen DNP in situ immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was observed, and results of clinical follow-ups were also examined.


Eligibility: Inclusion Criteria:
  -  pathologically diagnosed as malignant melanoma, HMB45 (+～++++), S100 (+～++++);
  -  Basically normal hepatic and renal functions as well as results for blood routine examinations;
  -  Karnofsky score ≥ 60;
  -  Anticipated life span for more than three months;
  -  They were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin;
  -  The therapeutic efficacy was objectively evaluated with reference to the criteria from WHO;
  -  All of the subjects had signed the informed consent and had been submitted and approved by the ethic committee of the hospital, the compliance was good and follow-ups can be easily carried out.

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: PCA062 in pCAD-positive Tumors.

Summary: A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.


Eligibility: Inclusion criteria:
  1. Male or female ≥ 18 years of age
  2. Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
  3. Consent for a tumor biopsy at screening
  4. Progressive disease and no effective therapy exists
  5. Measurable disease as per RECIST v1.1 criteria
  6. ECOG Performance status of ≤ 2
  Exclusion criteria:
  1. CNS metastatic involvement
  2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
  3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
  4. Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
  5. Previously treated with anti-pCAD biologic therapies.
  6. Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
  -  Conventional cytotoxic chemotherapy: ≤4 weeks
  -  Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks
  -  Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)
  -  Other investigational agents: ≤4 weeks
  -  Radiation therapy (palliative setting is allowed.): ≤4 weeks
  -  Major surgery: ≤2 weeks
  7. Patient has out of range laboratory values defined as:
  -  Hematological values:
  -  Absolute neutrophil count (ANC) <1.5 x 109/L
  -  Hemoglobin (Hgb) <9 g/dL
  -  Platelets <100 x 109/L
  -  Hepatic and renal function
  -  Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.
  -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN for patients without tumor involvement of the liver or >5 x ULN for patients with tumor involvement of the liver.
  -  Serum creatinine >1.5 x ULN and/or measured creatinine clearance < 40 ml/min

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 REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Summary: This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.


Eligibility: Key Inclusion Criteria:
  1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
  2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Key Exclusion Criteria:
  1. 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). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
  2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
  3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of REGN2810. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
  4. Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (ie, without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of REGN2810 (certain exceptions may apply).
  5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
  The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial ,therefore not all inclusion/ exclusion criteria are listed.

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: Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)

Summary: Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.
  This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.


Eligibility: Inclusion Criteria:
  -  Cutaneous melanoma with a tumour thickness of at least 1,00mm
  -  Positive sentinel node with micro metastases of max. 2mm in diameter
  Exclusion Criteria:
  -  Mucosal or ocular melanoma
  -  Cutaneous melanoma located in the head/neck region
  -  Evidence of satellite, in transit or local metastases / recurrences
  -  Macro metastases of the SN or micro metastases of >2mm in diameter
  -  Additional immune-suppressive therapy
  -  Pregnant of lactating women

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: Melanoma Perception and Health Literacy in People of Color

Summary: This study will examine the effectiveness of a targeted, health literate educational intervention for people of color compared to a standard melanoma education pamphlet for increasing knowledge and promoting early melanoma detection. It is hypothesized that people of color are less aware of their risk for developing melanoma and that a targeted educational intervention will help increase knowledge and promote early melanoma detection especially in individuals with low health literacy.

Detailed description: This targeted educational intervention will compare a standard melanoma education pamphlet with one that has been modified to target people of color. Both pamphlets will include the ABCDEs of melanoma, risk factors, prevention and treatment. In addition, the targeted pamphlet will incorporate the recommendations made by people of color in previous studies. The pamphlets will be randomized to subjects at a study visit along with a health literacy test and a questionnaire aimed at determining subjects' baseline melanoma knowledge and current melanoma prevention practices. 2 months post-intervention, a follow-up phone call will be made to assess subject knowledge retention and behavior change.

Eligibility: Inclusion Criteria:
  -  English-speaking
  -  Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic
  Exclusion Criteria:
  -  Not proficient in English
  -  Unable to give informed consent
  -  Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic

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: Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

Summary: This study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation phase (I) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.


Eligibility: Inclusion Criteria:
  Phase I part:
  - Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
  Phase II part:
  -  Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups:
  -  Group 1: NSCLC
  -  Group 2: Melanoma
  -  Group 3: Renal cancer
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  -  Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines.
  Exclusion Criteria:
  -  History of severe hypersensitivity reactions to study treatment ingredients or other mAbs
  -  Active, known or suspected autoimmune disease
  -  Active infection requiring systemic antibiotic therapy
  -  HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  -  Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency
  -  Patients receiving systemic treatment with any immunosupressive medication
  -  Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment
  -  Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.
  -  Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks
  -  History of drug-induced pneumonitis or current pneumonitis.

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 GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors

Summary: This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Life expectancy at least 12 weeks
  -  Adequate hematologic and end organ function
  -  Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
  -  Locally advanced, recurrent, or metastatic incurable solid malignancy with measurable disease per RECIST v1.1
  -  Progression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of care
  -  For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer
  -  For the expansion stage, evaluable for PD-L1 expression
  -  Anti PD-1/PD-L1 relapsed cohorts (I and II), participants whose most recent anti-cancer therapy consisted of single-agent PD-1/PD-L1 blockade will be enrolled
  Exclusion Criteria:
  -  Significant cardiovascular or liver disease
  -  Major surgery within 28 days of study drug
  -  Any anti-cancer therapy within 3 weeks of study drug
  -  Malabsorption syndrome or poor upper gastrointestinal integrity
  -  Primary central nervous system (CNS) malignancy or active metastases within 5 years
  -  Uncontrolled tumor pain
  -  Autoimmune disease other than stable hypothyroidism or vitiligo
  -  Human immunodeficiency virus (HIV), active hepatitis B or C, or tuberculosis
  -  Signs/symptoms of infection, or use of antibiotics within 2 weeks of study drug
  -  Live attenuated vaccine within 4 weeks of study drug
  -  Known history or predisposition to QT interval prolongation
  -  Prior cancer immunotherapy, specifically indoleamine 2,3-dioxygenase (IDO) or tryptophan 2,3-dioxygenase (TDO) inhibitors, T-cell costimulatory receptor agonist antibodies, or checkpoint inhibitors among certain participants

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: Hepatic RFA Increases T Cell Infiltraion and PD-L1 Expression in Primary Colorecatl Cancer

Summary: It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human carcinoma. However, there are insufficient studies on the immune modulation of tumor microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in human cancer patients, investigators performed a retrospective study of a unique cohort of patients who suffered from synchronous CRCLM.

Detailed description: Radiofrequency ablation (RFA) is widely used as a local treatment for tumors such as small hepatocellular carcinomas, renal cancer and solitary colorectal cancer liver metastases (CRCLM). RFA induces localized coagulation necrosis and leads to the release of large amounts of cellular debris in situ, which can serve as a source of tumor antigens to elicit host adaptive immune responses against tumors. Several studies on preclinical animal models have shown that localized tumor ablation by RFA can induce systemic T-cell mediated antitumor immunity. Antigen-specific T cell immune responses were also observed in patients with hepatic tumors after RFA therapy. However, the RFA-induced immune responses are not sufficient to prevent tumor recurrence. The underlying mechanisms remain obscure.
  Programmed death-ligand 1 (PD-L1), an important immune checkpoint molecule, is often up-regulated on tumor cells and tumor associated myeloid cells. It impairs T cell-mediated immune responses upon engagement with its cognate co-inhibitory receptor PD-1, which is always highly expressed on tumor-infiltrating lymphocytes. PD-L1 expression can be induced by pro-inflammatory cytokines, especially type I interferon (IFN), as an important self-limiting mechanism to prevent rampant autoimmunity. Recent studies show that PD-L1 expression on tumor cells is associated with T cell infiltration, suggesting PD-L1 is actively involved in suppressing antitumor immune responses in the tumor microenvironment (TME). Whether the PD-L1/PD1 axis is involved in modulating the antitumor T cell immune responses induced by RFA is unclear.
  The objective of this investigation was to study the RFA-induced immune responses in tumor tissues from cancer patients.

Eligibility: Inclusion Criteria:
  Patients with histologically confirmed asynchronous liver metastases received initial hepatic RFA or initial primary tumor resection.
  Exclusion Criteria:
  1. Preoperative CT, RT and other antitumor treatment
  2. Emergency surgery
  3. Initial hepatectomy
  4. No qualified endoscopic biopsy

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: Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)

Summary: The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors


Eligibility: Inclusion Criteria:
  -  Male or female subjects aged greater than or equal to (>=) 18 years
  -  With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
  -  At least 1 measurable tumor lesion
  -  With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
  -  With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
  -  Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
  -  Other protocol defined criteria could apply
  Exclusion Criteria:
  -  Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
  -  Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
  -  Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v 4.03.
  -  Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
  -  Other protocol defined criteria could apply

Relevance to patient case: not relevant