araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

Summary: The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Detailed description: Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized

Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Unresectable Stage III or Stage IV melanoma
  -  Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
  -  Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  -  Normal liver function tests
  Exclusion Criteria:
  -  Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
  -  Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
  -  Autoimmune disease

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Trial of pIL-12 Electroporation Malignant Melanoma

Summary: This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12 DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12 EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.

Detailed description: Plasmid IL-12 (pIL-12) at a concentration of 0.5 mg/mL will be injected intratumorally at a dose volume of ¼ of the calculated lesion volume and a dose volume per lesion of 0.1 mL for lesions of volume < 0.4 cm3. Six pulses at field strengths of (E+) of 1500 V/cm and pulse width of 100 μs at 1-second intervals will be administered using the OMS to each previously injected tumor.
  Two treatment regimens will be explored:
  Regimen A: Treatment on Days 1, 8 and 15 every 6 weeks Regimen B: Treatment on Days 1, 5 and 8 every 6 weeks. Lesions will be treated on either Regimen A or Regimen B. Subsequent cycles may be given at 6-week intervals, for up to 9 treatment cycles in total.

Eligibility: Inclusion Criteria:
  -  Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma
  -  Age ≥ 18 years of age
  -  ECOG performance status 0-2
  -  Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon, ipilimumab, or IL-2) with progression or persistent disease
  -  Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be treated are within the radiation field
  -  Female patient of childbearing potential has a negative pregnancy test within 14 days prior to the start of study drug
  -  Adequate organ function
  -  Able to give informed consent
  Exclusion Criteria:
  -  Prior therapy with IL-12 or prior gene therapy
  -  Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of subject participation on study
  -  Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study enrollment
  -  Pregnant or breast-feeding women
  -  Patients with electronic pacemakers or defibrillators are excluded from this study
  -  The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition (patients with thyroiditis are eligible)
  -  Life expectancy of less than 6 months
  -  History of significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias)
  -  Other clinically significant co-morbidities such as uncontrolled pulmonary disease, uncontrolled diabetes, active CNS disease, active infection or any other condition that could compromise the patients participation in the study according to the investigator

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Summary: People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.


Eligibility: Inclusion Criteria:
  -  1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
  -  Life expectancy of at least 6 months
  -  Aged 18 years or older
  -  WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
  -  Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines
  -  Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
  -  An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
  -  CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
  -  Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal
  -  Able to provide written informed consent
  Exclusion Criteria:
  -  Any untreated intracranial disease
  -  Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
  -  Evidence of leptomeningeal disease on pre-local treatment MRI scan
  -  Patients with prior cancers, except:
  -  Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
  -  Successfully treated basal cell and squamous cell skin carcinoma;
  -  Carcinoma in-situ of the cervix
  -  A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
  -  Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain

Summary: The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.


Eligibility: Inclusion Criteria:
  -  Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
  -  CSF flow abnormalities must be excluded
  -  Males or females ≥ 18 years of age
  -  Karnofsky Performance Status > 50%
  -  Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)
  Exclusion Criteria:
  -  Unresected parenchymal brain metastases with a diameter > 3 cm
  -  Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  -  Prior intrathecal chemotherapy
  -  Prior treatment with systemic cytarabine or nitrosureas
  -  The patient ist pregnant or breast feeding
  -  Severe, active co-morbidities

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Summary: Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.
  Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.
  Secondary objectives:
  -  determine the percentage of patients with metastatic melanoma with melanoma cells circulating
  -  seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
  -  seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma


Eligibility: Inclusion Criteria:
  -  Patients > or = 18 years
  -  Patients with advanced melanoma stage IIIC (unresectable) or stage IV
  -  Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month
  -  Patients who signed informed consent
  -  Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
  -  Patients with a life expectancy greater than 3 months
  -  Patients with melanoma measurable by RECIST version 1.1
  -  Patients with venous good for venipuncture
  Exclusion Criteria:
  -  Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
  -  Pregnant women or nursing
  -  People vulnerable detainees, adults under guardianship or curatorship, minors.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of of GSK2118436 in Japanese Subjects With BRAF Mutation Positive Solid Tumors

Summary: BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors using continuous daily dosing schedule.

Detailed description: BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors using continuous daily dosing schedule. Dose escalation of GSK2118436 will be performed according to a standard 3+3 dose-escalation design. GSK2118436 is given twice a day. However, to characterize the PK of GSK2118436 and its metabolites after single-dose administration, GSK2118436 will NOT be administrated for a week after the first administration. GSK2118436 continuous dosing will start after the 168-hour PK sample is obtained. Subjects may receive study treatment until disease progression, death or an unacceptable adverse event.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy.
  -  Subjects must have BRAF V600E or K mutant positive tumors.
  -  Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
  -  Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
  -  Must have adequate organ function.
  -  Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  Exclusion Criteria:
  -  Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
  -  Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436.
  -  A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  -  History of Human Immunodeficiency Virus (HIV) infection.
  -  Certain cardiac abnormalities.
  -  Pregnant or lactating female.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.


Eligibility: Inclusion Criteria:
  -  patients more than 18 years old,
  -  consulting their GP,
  -  assessed at risk for melanoma according to the SAMScore
  -  signed the consent.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Summary: This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
  Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed description: Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.

Eligibility: Inclusion Criteria:
  1. Pathologically proven unresectable NSCLC
  2. 20 years of age or older
  3. Planned treatment with Iressa®
  4. Patients with activating EGFR mutation (del 19, L858R)
  5. Available detailed smoking history
  6. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
  7. Available blood sample
  8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
  9. Written informed consent
  Exclusion Criteria:
  1. More than 3rd line treatment
  2. Previously treated with other EGFR-TKI
  3. Life expectancy of less than 12 weeks
  4. Pregnant or lactating female
  5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
  6. Unsuitable patient in this treatment as determined by doctor.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

Summary: The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Men & women ≥ 18 years of age
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  -  Histologically confirmed Stage III (unresectable)/Stage IV melanoma
  -  Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  -  Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
  -  Pre-treatment fresh core, excision or punch tumor biopsy
  -  Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
  Exclusion Criteria:
  -  Any treatment in a BMS-936558 (Nivolumab) trial
  -  Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
  -  Active, known or suspected autoimmune disease
  -  Unknown BRAF status
  -  Active brain metastasis or leptomeningeal metastasis
  -  Ocular melanoma
  -  Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Study of the KineSpring® System to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis

Summary: The purpose of this pilot study is to collect data on the safety and effectiveness of the KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.

Detailed description: The KineSpring System is indicated to treat symptoms of pain and loss of knee function in patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee. The KineSpring System is indicated for patients with osteoarthritis of severity that does not require knee joint replacement.

Eligibility: Inclusion Criteria (Significant criteria only. Others also apply):
  -  Patients with symptoms of knee pain and loss of knee function.
  -  Patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee.
  -  Radiographic confirmation of mild to moderate medial compartment knee OA
  Exclusion Criteria (Significant criteria only. Others also apply):
  -  Patients that that require knee joint replacement.
  -  Symptomatic OA in lateral compartment or patellofemoral compartment.
  -  Known sensitivity to metals including cobalt, chromium, iron, or nickel
  -  Rheumatoid arthritis, other forms of inflammatory joint disease

Relevance to patient case: not relevant