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: Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Summary: To assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 alone and in combination with Nivolumab in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  For Dose escalation: subjects with cervical, ovarian, bladder and CRC, head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
  -  For Dose Expansion: all of the above in escalation except for cervical, ovarian bladder and CRC
  -  Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
  -  ECOG performance status of 0 or 1
  -  At least 1 lesion with measurable disease at baseline
  -  Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
  Exclusion Criteria:
  -  Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
  -  Autoimmune disease
  -  Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  -  Uncontrolled CNS metastases

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: MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

Summary: This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).


Eligibility: Inclusion Criteria:
  -  Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-PD/PD-L1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment
  -  Subjects need to have
  -  one lesion that can be irradiated
  -  at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated
  -  one lesion that can be biopsied before treatment with SBRT and MSB0010445
  -  one lesion outside the radiation field that can be biopsied while on treatment with MSB0010445
  -  The lesion that is biopsied at Baseline can be the lesion that will be irradiated
  -  The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at Baseline
  -  Signed written informed consent
  -  Male and female subjects at least 18 years of age
  -  Life expectancy greater than or equal to (>=) 4 months
  -  Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  -  Other protocol defined inclusion criteria could apply
  Exclusion Criteria:
  -  Active central nervous system metastasis
  -  Treatment with systemic anti-cancer therapy within the 30 days before the first dose of SBRT
  -  Pre-existing pericardial effusion or history of Grade >=2 pleural effusion or ascites within 3 months before first dose of SBRT
  -  Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
  -  Other protocol defined exclusion criteria could apply

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

Clinical trial: Expression and the Clinical Significance of Neutrophil PD-L1 During Sepsis

Summary: Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.


Eligibility: Inclusion Criteria:
  -  patients with severe sepsis
  -  patients with sepsis after PCNL for infectious kidney stone
  -  patients with pancreatic cancer
  -  healthy volunteers
  Exclusion Criteria:
  -  patients with immunodeficient diseases
  -  patients who accept glucocorticoid or immunosuppressant
  -  patients with an age older than 18 years
  -  patients providing the informed consent

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

Clinical trial: Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

Summary: The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of malignant melanoma
  -  Previously-treated or untreated unresectable Stage III or Stage IV melanoma
  -  Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion Criteria:
  -  Active brain metastases
  -  Primary ocular or mucosal melanoma
  -  History of or current active autoimmune disease

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

Clinical trial: Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

Summary: The purpose of this study is to determine the maximum tolerated dose and the safety profile of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type BRAF, respectively.


Eligibility: Inclusion Criteria:
  -  Adults >/= 18 years old
  -  Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable) or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive (cohort A) or mutation-negative (cohorts B and C)
  -  ECOG performance status of 0 or 1
  -  Measurable disease by radiographic or physical examination
  -  Adequate organ and marrow function
  -  Willingness to provide consent for biopsies positive or BRAF WT measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ and marrow function
  Exclusion Criteria:
  -  Prior treatment with a BRAF inhibitor or MEK inhibitor
  -  Any prior Grade ≥ 3 immune-related adverse event while receiving immunotherapy
  -  Active or prior documented autoimmune disease within the past 2 years
  -  History of or current risk for retinal vein occlusion (RVO) or central serous retinopathy (CSR)
  -  History of or current cardiovascular risk including myocardial infarction, ≥ Class II congestive heart failure, uncontrolled arrhythmias, or refractory hypertension
  -  Active, untreated CNS metastases
  -  Women who are pregnant or lactating

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 Global Study to Assess the Effects of MEDI4736 in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Summary: A study to assess the Effects of MEDI4736 in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Detailed description: This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736, in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy

Eligibility: Inclusion Criteria:
  -  Aged at least 18 years.
  -  Documented evidence of NSCLC (stage IIIB/IV disease)
  -  Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
  -  World Health Organisation (WHO) Performance Status of 0 or 1
  -  Estimated life expectancy of more than 12 weeks
  -  Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))
  Exclusion Criteria:
  -  Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  -  Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
  -  Active or prior autoimmune disease or history of immunodeficiency
  -  Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  -  Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
  -  Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
  -  Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
  -  Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

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 to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer

Summary: The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.

Detailed description: SLNB is based on the premise that lymphatic dissemination from a tumour occurs in a stepwise fashion, with initial involvement of a primary node, called the sentinel node, before dissemination to the remainder of the lymphatic chain. If the sentinel node is histologically negative, then the remainder of the nodes in the same anatomic region will be at a lower (assumed to be minimal) risk of containing metastases. SLNB is part of standard care for patients with malignant melanoma and with breast cancer but has yet to be prospectively evaluated in patients with anal cancer.
  Currently, the standard way to treat patients with anal cancer is to deliver a combination of chemotherapy and radiation to the tumour at the anus together with 'preventative' (prophylactic) radiotherapy to the lymph glands of the groin and pelvis. There is a growing perception for the need to reduce the morbidity of radiotherapy i.e. current regimens over-treat the patient and one approach is to reduce radiotherapy volume and/or dose where there is an absence or very low risk of nodal metastases.
  This feasibility study is a vital first step in informing the design of a larger study examining the role of SLNB in clinical decision-making and outcomes for patients with anal cancer. In this trial eligible patients will attend for lymphoscintigraphy, to locate the lymph node, before sentinel lymph node removal by surgery. Detection rate of the sentinel node(s) will be the key outcome for the study.

Eligibility: Inclusion Criteria:
  -  Patients with squamous cell carcinoma (SCC) of the anus (any T size and/or those with recurrent disease)
  -  Equivocal lymph node involvement on standard CT staging or magnetic resonance (MR) staging or PET-CT scan, as determined by the anal cancer multidisciplinary team (MDT)
  -  Age >= 18 years
  -  Written informed consent provided by the patient
  Exclusion Criteria:
  -  Patients with unequivocal lymph node involvement on standard CT staging or MR staging, as determined by the anal cancer MDT.
  -  Unfit for surgical biopsy
  -  Patients undergoing palliative treatment
  -  Previous pelvic or inguinal area radiotherapy
  -  Other coincident cancers
  -  Previous inguinal surgery (e.g. hernia repair) with mesh insertion

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 Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma

Summary: This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average.
  Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.
  The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.


Eligibility: Inclusion Criteria:
  1. Patients ≥ 18 years of age.
  2. Patient must be able to give own signed informed consent.
  3. Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin.
  4. Patients that are planned to receive either:
  -  Adjuvant treatment
  -  1st line treatment for metastatic disease
  -  2nd line treatment for metastatic disease
  5. Patients with prior adjuvant treatment are allowed.
  6. Patients receiving planned standard treatment of one or more of the following:
  -  Chemotherapy regimens containing DTIC, TMZ and/or cisplatin
  -  Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies)
  -  BRAF and/or MEK inhibitors
  7. Patients were FFPE and fresh frozen tissue is available (both mandatory).
  Exclusion Criteria:

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: Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma

Summary: The purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Men and women 18 years and older
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  -  Histologically-confirmed unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular melanoma
  -  Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects may have had other prior systemic treatment for localized or metastatic disease
  -  Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in Immunosuppression (>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration
  Exclusion Criteria:
  -  Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
  -  Life expectancy < 6 weeks
  -  Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll
  -  Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
  -  Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab

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

Clinical trial: Phase I-II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation and Pharmacokinetics of PD-0332991 in Patients Suffering Metastatic Melanoma

Summary: An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD) evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering metastatic melanoma with BR.
  The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.


Eligibility: Inclusion Criteria:
  -  Age > 18 years
  -  Stage IV or un-resectable stage III melanoma
  -  Presence of BRAF V600E/K mutation and CDNKN2A loss and expression of Rb using immunohistochemistry in a recent metastatic sample (< 6 months)
  -  A previous exposure to BRAF inhibitor or combination of BRAF and MEK inhibitors therapy is allowed unless it has been stopped more than 3 months before study enrolment(This will defined the two strata of the trial)
  -  No previous therapy by MEK inhibitor unless associated with BRAF inhibitors
  -  No previous therapy with the AKT/PI3K pathway inhibitor
  -  Patients should have a tumour available for repeated biopsies for pharmacodynamics evaluation
  -  Life expectancy of > 3 months
  -  ECOG performance status <2
  -  Signed informed consent
  -  Patient with health insurance coverage
  -  No patient under guardianship or curators
  Exclusion Criteria:
  -  Inadequate hepatic function defined as serum bilirubin>25 μmol/l, transaminases > 3.0 times the upper limit of normal (ULN) or 5ULN in cases of liver metastases;
  -  Inadequate bone marrow function defined as absolute neutrophil count<1500/mcl, platelets<150000/mcl and haemoglobin<8g/dL
  -  Inadequate renal function with serum creatinine>2.0mg/dl) and /or creatinine clearance< 60 ml/min
  -  Untreated brain metastases : Patients with brain metastases will be eligible if they have completed treatment 1 months prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 5 days, and are neurologically asymptomatic
  -  Myocardial infarct or unstable angina within the past 6 months
  -  Concomitant take of drugs known to be strong inhibitor or inducers of CYP314
  -  HIV positive.
  -  Chemotherapy, immunotherapy within 4 weeks
  -  Drugs interfering with PD-0332991 and vemurafenib metabolism
  -  Malabsorption syndrome or other condition that would interfere with enteral absorption
  -  Congenital long QT syndrome or screening QTc > 470 msec
  -  Need for chronic corticosteroid therapy of ≥10 mg of prednisone per day

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 Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Summary: This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Male and female subjects
  -  18 years and older
  -  Histologic confirmation of advanced solid tumors
  -  Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
  Exclusion Criteria:
  -  Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
  -  Active or prior documented autoimmune disease within the past 2 years
  -  Current or prior use of immunosuppressive medication within 14 days with some exceptions.

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: Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography

Summary: The investigators will use optical coherence tomography to detect the ex-vivo tissue image of surgical removed melanoma or other benign pigmented lesions of skin.

Detailed description: The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe skin tissue images in ex vivo culture. Parts of melanoma or benign pigmented lesions specimens derived from biopsy or surgical excision specimen will be observed by 3D optical tomography. A tiny tissue fragment of melanoma or benign pigmented lesions will be taken from surgical specimen without interference normal pathological evaluation. The location of melanocytic cells in melanoma or benign tissue fragments will be mapped by the 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be dermatological patients who need to surgical intervention.

Eligibility: Inclusion Criteria:
  -  Patients aged older than 20 years old
  -  Patients who had melanoma, melanoma in situ, and/or other benign pigmented lesions,
  -  Patients who had non-melanoma skin cancers (basal cell carcinoma, or squamous cell carcinoma).
  -  Patients who had precancerous skin lesions (Bowen's disease, actinicc keratosis)
  Exclusion Criteria:
  • Pregnant women.

Relevance to patient case: not relevant