araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

Summary: This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.
  -  Presence of measurable disease
  -  Age > or = 18 years and < or = 75 years
  -  Performance status (ECOG) 0 - 2 (Appendix 2)
  -  Life expectancy ³ 3 months
  -  Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl), normal liver and renal function (bilirubin < 1.25 x N, creatinine < 1.25 x N, SGOT, SGPT < 3 times upper normal limit of testing laboratory.
  -  Written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  -  Prior surgery > 3 weeks from initiating .
  -  If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.
  -  Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.
  Exclusion Criteria:
  -  Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
  -  Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)
  -  Known HIV disease.
  -  Concurrent treatment with other experimental drugs.
  -  Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
  -  Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
  Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Study of Immune Responses in Patients With Metastatic Melanoma

Summary: In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.


Eligibility: Inclusion Criteria:
  1. Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
  3. Age 18 years or above.
  4. Laboratory values (performed within 28 days prior to enrollment) as follows:
  -  WBC ≥2000/microliter
  -  Absolute lymphocyte count >300/mm3
  -  Serum creatinine <1.5 X upper limit of laboratory normal
  -  Hgb >8g/dl (patients may be transfused to reach this level)
  -  Hct > 24%
  -  Platelets >100,000 cells/mm3
  -  Total bilirubin <1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
  -  AST (SGOT)/ALT (SGPT) <2.5 X upper limit of laboratory normal
  -  Alkaline phosphatase <2.5 X upper limit of laboratory normal
  -  HIV Negative
  -  Hepatitis B surface antigen Negative
  -  Hepatitis C antibody Negative
  5. Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy.
  6. Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
  7. No active bleeding.
  8. No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds).
  9. Anticipated lifespan greater than 12 weeks.
  10. Failed at least one prior medical therapy for metastatic melanoma.
  Exclusion Criteria:
  1. Active infection.
  2. History of or active autoimmune disease.
  3. Prior mouse monoclonal antibody treatment.
  4. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  5. Need for chronic maintenance oral steroids.
  6. Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible.
  7. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

Summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.


Eligibility: Inclusion Criteria:
  For the dose escalation phase:
  1. Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
  2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
  3. Evidence of measurable disease
  Exclusion Criteria:
  1. Previous therapy with a MEK inhibitor.
  2. Symptomatic or untreated leptomeningeal disease.
  3. Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
  4. Known acute or chronic pancreatitis.
  5. Clinically significant cardiac disease
  6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
  7. Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
  8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
  9. History of thromboembolic or cerebrovascular events within the last 6 months
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Tecemotide (L-BLP25) in Rectal Cancer

Summary: The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.
  Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs).


Eligibility: Inclusion Criteria:
  1. Male and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4
  2. Availability of tumor biopsy sufficient for immunological analysis
  3. Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable
  4. Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization
  5. Eastern Cooperative Oncology Group performance status of 0 or 1
  6. Written informed consent
  7. Greater than or equal to (>=) 18 years of age
  Exclusion Criteria:
  1. Previous chemotherapy and/or previous radiotherapy of the pelvic region
  2. Relapsing disease
  3. Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines
  4. Previous organ transplantation (bone marrow or solid organs)
  5. Subjects with metastatic disease (except for solitary, resectable liver or lung metastases)
  6. Inadequate hematological function (that is, platelet count less than 140*10^9 per liter [/L], or white blood cell less than 2.5*10^9/L, or hemoglobin less than 90 gram per liter). Clinically significant hepatic dysfunction (that is alanine aminotransferase greater than 2.5*upper limit of normal [ULN], or aspartate aminotransferase greater than 2.5*ULN, or bilirubin greater than 1.5*ULN). Inadequate renal function (that is serum creatinine greater than 1.5*ULN)
  7. Autoimmune diseases
  8. Recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
  9. Clinically significant cardiac disease, for example, New York Heart Association Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by medical history and an electrocardiogram
  10. Other protocol defined exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

Summary: The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed Stage IIb, IIc, III melanoma
  -  Surgical resection within 90 days of first dosing
  -  Persons with positive sentinel nodes must have a complete lymphadenectomy
  -  ECOG performance status 0 or 1
  Exclusion Criteria:
  -  Any prior melanoma treatment other than surgery or regional irradiation
  -  Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
  -  Use of biologic response modifiers within 60 days of first dosing
  -  Subjects with history of other malignancy within past 5 years (with exceptions)

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF

Summary: Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application
  -  EGFR immunohistochemistry score > 5
  -  Male
  -  Age 18-60 years
  Exclusion Criteria:
  -  Systemic psoriasis treatment 3 months prior and during the study
  -  Local psoriasis treatment on the investigational sites in the last 30 days or during the study
  -  Known hypersensitivity or allergy to the EGF containing product (Newskin) and/or to Vaseline/10% salicylic acid and/or to local anaesthetics of the amid type
  -  Known or suspected non-compliance to study protocol Coagulopathy or treatment with anticoagulants
  -  History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

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: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Anesthesia and Cancer Recurrence im Malignant Melanoma

Summary: Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination.
  The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

Detailed description: Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
  -  Signed informed consent
  Exclusion Criteria:
  -  Age < 18 years
  -  Female patients who are pregnant or nursing
  -  Multiple organ failure
  -  Contraindications

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma

Summary: The study design includes an open-label, dose escalation phase followed by a blinded, randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved therapy and compares to approved therapy plus placebo in metastatic melanoma patients.


Eligibility: Inclusion Criteria:
  -  Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
  -  A life expectancy of >12 weeks.
  -  Laboratory ranges and medical criteria met, as defined within the protocol.
  -  Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
  -  For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.
  Exclusion Criteria:
  -  Pregnant or nursing women.
  -  Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
  -  Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
  -  Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-PD-1, anti- PD-L1 and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
  -  Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
  -  Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.

Relevance to patient case: not relevant
Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

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: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Efficacy and Safety of Intratumoral CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks

Summary: This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.


Eligibility: Inclusion Criteria:
  -  1. Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction.
  -  2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not have "rapid clinical deterioration" by the investigator since the subject's last tumor measurement leading to irPD assessment.
  -  3. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
  -  4. Patient is able and willing to provide written informed consent to participate in the study.
  -  5. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.
  Exclusion Criteria:
  -  1. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
  -  2. If lesions are too small to be visualized or palpable for accurate injection.
  -  3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.

Relevance to patient case: not relevant