Important: Models were tasked with extracting evidence from documents. Some outputs may be low quality and should be scored accordingly.
Your task: Compare the model-generated prediction (right panel) against the ground truth criteria (left panel).
Evaluation scale (0-4):
Consider both content accuracy and completeness. Some predictions may be technically "correct" but incomplete or out of order.
INCLUSION CRITERIA 1. Written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information prior to registration for protocol therapy. 2. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 3. Age ≥ 18 years at the time of consent. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy. 5. Histological evidence of primary Stage III or IV or recurrent endometrial carcinoma who have had definitive surgery for endometrial cancer. 6. Pathologic documentation of the recurrence is required if there is only a single site of disease on imaging and that site is less than 2cm. 7. If a subject with recurrence is undergoing a biopsy for clinical indications and is willing and able, an optional collection of 3 frozen tissue cores of the recurrence site is requested for correlative analysis. 8. Measurable disease according to RECIST v1.1 and obtained by imaging within 28 days prior to registration for protocol therapy. 9. Disease in an irradiated field as the only site of measurable disease is acceptable only if there has been clear progression since completion of radiation treatment. 10. The subject must have recovered (</= grade 1) from the acute toxic effects of prior therapy. 11. NOTES: Subjects may have received a single platinum-based cytotoxic chemotherapy regimen. 12. Subjects having received prior cytotoxic chemotherapy must have completed their treatment more than 6 months prior to registration. 13. Subjects may have received prior therapy with hormones or biologic agents, but such therapies must be discontinued at least 28 days prior to registration for protocol therapy. 14. The subject must have completed prior radiation therapy at least 28 days prior to registration for protocol therapy. 15. NOTES: Subjects may have received prior radiation therapy for treatment of endometrial carcinoma. 16. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy. 17. Chemotherapy used for radiation sensitization is allowed. 18. Chemotherapy used for radiation sensitization will not count as second chemotherapy regimen. 19. Subjects with recurrence, subjects must have a documented complete response upon completion of initial definitive therapy. 20. No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 5 years. 21. Female subjects must be of non-childbearing potential. 22. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥1 year. EXCLUSION CRITERIA 1. Subjects with carcinosarcoma. 2. Subjects who have a solitary central pelvic recurrence which can be curatively resected. 3. Hypersensitivity to pembrolizumab or any of its excipients. 4. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to registration for protocol therapy or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 6. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to registration for protocol therapy and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior registration for protocol therapy. 7. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. 8. NOTE: Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. 9. Treatment with any investigational agent within 28 days prior to registration for protocol therapy. 10. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 11. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 12. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 13. Has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to registration for protocol therapy. 14. Has a known history of active TB (Bacillus Tuberculosis)Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or hypersensitivity pneumonitis. 15. Has a history of (non-infectious) pneumonitis that required steroids or active, non-infectious pneumonitis. 16. Evidence of interstitial lung disease. 17. Has an active infection requiring systemic therapy with the exception of an uncomplicated urinary tract infection. 18. Pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v 4 criteria. 19. Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent. 20. Has a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HVC RNA [quantitative] is detected). 21. Has received a live vaccine within 30 days prior to registration for protocol therapy. 22. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. 23. History of solid organ or stem cell transplant requiring immunosuppressive medications.
Based on the information provided, here is the modified eligibility criteria for version 6: Version Context: This task is for the transition from ClinicalTrials.gov version 5 to version 6. The evidence may use different labels (e.g. "Amendment 1", "Version 2.0") that do not always match our version numbers 1:1; use the evidence to infer the intended change. Original Eligibility Criteria (version 5): Age ≥ 18 years at the time of consent. Economic status (income): Not Submitting to IRB Approval: Expected IRB Approval Date: Please Complete and Email to BTCRC ADMINISTRATIVE HEADQUARTERS Instructions to the site investigator: Please SIGN and DATE this signature page. PRINT your name and title, the name and location of the facility in which the study will be conducted, and the expected IRB approval date. Scan and email the completed form to BTCRC Administrative Headquarters and keep a record for your files. EXCLUSION CRITERIA 1. Carcinosarcoma. 2. Hyper-Sensitivity to pembrolizumab or any of its excipients. 3. History of prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to registration for protocol therapy. 4. Previous anti-cancer monoclonal antibody (mAb) with prior cytotoxic chemotherapy regimen. 5. Prior cytotoxic chemotherapy with hormones or biologic agents. 6. Recurrent endometrial carcinoma. 7. Patient with a single platinum-based cytotoxic chemotherapy regimen. 8. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 9. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 10. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 11. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 12. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 13. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 14. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 15. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 16. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 17. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 18. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 19. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 20. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 21. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 22. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 23. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 24. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 25. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 26. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 27. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 28. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 29. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 30. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 31. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 32. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 33. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 34. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 35. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 36. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 37. Patient with a prior cytotoxic chemotherapy with hormones or biologic agents. 38. 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