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

Clinical trial: Mohs and Immunofluorescence for Malignant Melanoma In Situ

Summary: The purpose of this study is to determine if immunofluorescence (IF) can effectively identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs Micrographic Surgery.

Detailed description: The aim of this study is to
  1. Determine the feasibility of using melanocytic markers such as Melanoma antigen recognized by T cells 1 (MART-1) with fluorescence to clear surgical margins when compared to conventional MART-1 immunohistochemistry (IHC) in the setting of MMS for LM (lentigo maligna type melanoma in situ).
  2. Compare the use of a cocktail of immunofluorescent markers such as, but not limited to, Sex-determining Region Y (SRY)-box 10 (SOX10), human melanoma black 45 (HMB-45), and Kiel-67 (Ki-67) to sections only stained with fluorescent MART-1 alone.
  3. Explore the value of using other combinations of immunofluorescent markers such as S-100 with Microphthalmia-associated transcription factor (MiTF), Nestin with Ki-67, and HMB-45 with Lamin.

Eligibility: Inclusion Criteria:
  1. Male or female of any race and at least 18 years of age
  2. Patient with biopsied proven Lentigo maligna (LM) in situ
  3. Patient meets criteria for Mohs Micrographic Surgery (MMS)
  1. The cancer is large
  2. The edges of the cancer (clinical margins) cannot be clearly defined
  3. Prior treatment has failed, i.e. recurrent tumor
  4. The cancer is located in a cosmetically sensitive or functionally critical area of the body (such as eyelids, nose, ears, lips, fingers, toes, and genitals)
  5. The histologic pattern of the cancer is aggressive
  6. The patient is immunosuppressed
  4. Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:
  1. Area H: ''Mask areas'' of face (central face, eyelids [including inner/outer canthi], eyebrows, nose, lips [cutaneous/mucosal/vermillion], chin, ear and periauricular skin/sulci, temple), genitalia (including perineal and perianal), hands, feet, nail units, ankles, and nipples/areola.
  2. Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
  3. Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
  5. Patient able to tolerate surgery
  6. Patient is able to comply with appointments including follow-up appointments
  7. Ability to understand and willingness to sign a written informed consent document
  Exclusion Criteria:
  1. Patients under the age of 18
  2. Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
  3. Patient with previously diagnosed invasive LM
  4. Patients unable to comply with follow-up
  5. Adults unable to consent
  6. Pregnant women
  7. Prisoners

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

Clinical trial: Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma

Summary: The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.

Detailed description: The successful treatment of melanoma with immune checkpoint inhibitors, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein 1 (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors. Despite these advances, only a portion of patients experience a durable response suggesting that there is room for improvement via enhanced immunomodulatory approaches. Anti-CTLA-4 (Ipilimumab) significantly improves overall survival and achieves long-lasting complete responses in some melanoma patients, the number of patients that achieve durable clinical benefit is limited and could be improved by a combined immunomodulatory approach. The objectives of this study are to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.

Eligibility: Inclusion Criteria:
  -  Patients over the age of 18 year.
  -  Patients diagnosed with Stage IV melanoma.
  -  Patients that are considered candidates for ipilimumab therapy.
  -  Patients able to understand and willing to sign a written informed consent documents.
  -  Patients willing to have regular blood draws, one before treatment and four during or after treatment.
  Exclusion Criteria:
  -  Patients that have received systemic treatments within four weeks prior to the beginning of treatment.
  -  Women that are pregnant or nursing.
  -  Patients with ocular melanoma.
  -  Patients taking immunosuppressive medications.
  -  Patients with active autoimmune disease.
  -  Patients with known sensitivity to retinoic acid derivatives.

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 Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

Summary: This randomized, open-label study is designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in participants with chemotherapy-naive, Stage IV squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed Stage IV squamous NSCLC
  -  Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
  -  No prior treatment for Stage IV squamous NSCLC
  -  Measurable disease as defined by RECIST v1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Adequate hematologic and end-organ function
  Exclusion Criteria:
  -  Active or untreated central nervous system (CNS) metastases
  -  Untreated or inadequately treated spinal cord compression
  -  Leptomeningeal disease
  -  Uncontrolled pleural effusion, pericardial effusion, or ascites
  -  Uncontrolled tumor-related pain
  -  Uncontrolled hypercalcemia
  -  Any other malignancies within 5 years except those with negligible risk of metastasis or death
  -  Pregnant or lactating women
  -  Known hypersensitivity to any component of atezolizumab formulation or other study medication
  -  History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
  -  Prior allogeneic bone marrow or solid organ transplantation
  -  Positive human immunodeficiency virus (HIV) test
  -  Active hepatitis B or C
  -  Active tuberculosis
  -  Significant cardiovascular disease
  -  Severe infection or major surgery within 4 weeks prior to randomization
  -  Use of any approved anti-cancer therapy within 3 weeks prior to treatment
  -  Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
  -  Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
  -  Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  -  Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

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 Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Summary: This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.


Eligibility: Inclusion Criteria:
  -  Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
  -  No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  -  Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
  -  A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
  -  Eastern Cooperative Oncology Group performance status of 0 or 1
  -  Measurable disease as defined by RECIST v1.1
  -  Adequate hematologic and end-organ function
  Exclusion Criteria:
  -  Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
  -  Leptomeningeal disease
  -  Pregnancy or lactation
  -  History of autoimmune disease
  -  Prior allogeneic stem cell or solid organ transplantation
  -  Positive test for human immunodeficiency virus
  -  Active hepatitis B or hepatitis C
  -  Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo

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: 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