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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)

- 11/2/20 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: Administrative, Non-Serious Adverse Event, Non-Serious Adverse Event , Death Form, Study Conclusion - Pregnancy Information, Study Conclusion, Study Conclusion - Investigator's Siganture
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Best overall response assessment; New tumor biopsy/ sample (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Administrative, Best overall response assessment, New tumor biopsy/ sample
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - One Year Survival Assessment (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Administrative, One Year Survival Assessment
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Unscheduled Visit (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 14 itemgroups, 39 items, 1 language
Itemgroups: Administrative, Unscheduled Visit , Physical Examination (Unscheduled Visit), Weight (Unscheduled Visit) , Conclusion of unscheduled visit , Unscheduled Tumor Assessment, Tumor Assessment, Tumor Assessment , Site evaluation for non-target lesion(s) and new lesions, Site evaluation for non-target lesion(s) and new lesions, Target lesion(s) evaluation, Response Assessment, Laboratory Tests, Laboratory Tests
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Radiotherapy; Local Surgery (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 5 itemgroups, 17 items, 1 language
Itemgroups: Administrative, Radiotherapy, Radiotherapy , Local Surgery, Local Surgery
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Treatment Conclusion (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Administrative, Pregnancy Information, Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Check for Study Continuation; Physical Examination; Laboratory Tests (Report Final and Annex Report 2 Final)

- 10/29/20 - 1 form, 43 itemgroups, 93 items, 1 language
Itemgroups: Administrative, Check for Study Continuation (Visit 1), Check for Study Continuation (Visit 2) , Check for Study Continuation (Visit 3) , Check for Study Continuation (Visit 4), Check for Study Continuation (Visit 5) , Check for Study Continuation (Visit 6) , Check for Study Continuation (Visit 7) , Check for Study Continuation (Visit 8) , Check for Study Continuation (Visit 9) , Check for Study Continuation (Visit 10) , Check for Study Continuation (Visit 11) , Check for Study Continuation (Visit 12) , Check for Study Continuation (Visit 13), Check for Study Continuation (Visit 14), Check for Study Continuation (Visit 15) , Check for Study Continuation (Visit 16) , Check for Study Continuation (Visit 17) , Check for Study Continuation (Visit 18) , Check for Study Continuation (Visit 19) , Check for Study Continuation (Visit 20) , Check for Study Continuation (Visit 21) , Check for Study Continuation (Visit 22), Check for Study Continuation (Visit 23) , Check for Study Continuation (Visit 24) , Check for Study Continuation (Visit 25), Check for Study Continuation (Visit 26), Check for Study Continuation (Visit 27), Check for Study Continuation (Visit 28) , Check for Study Continuation (Follow-Up) , Physical Examination (Visit 1), Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28), Physical Examination (Follow-Up) , Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up), Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28), Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up), Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up), HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27), End of follow-up
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment (Report Final and Annex Report 2 Final)

- 10/29/20 - 1 form, 9 itemgroups, 58 items, 1 language
Itemgroups: Administrative, Study Treatment Administration (Visit 1), Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27) , Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up), Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up) , Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up), Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up), Target lesion(s) evaluation (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up), Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Laboratory Tests (Annex Report 2 Final)

- 10/28/20 - 1 form, 8 itemgroups, 16 items, 1 language
Itemgroups: Administrative, Laboratory Tests, Laboratory Assay, Haematology, Biochemistry, Hepatic Function, Renal Function, HCG Urine or Blood Pregnancy Test
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Tumor Assessment; Baseline Melanoma Evaluation (Annex Report 2 Final)

- 10/28/20 - 1 form, 7 itemgroups, 18 items, 1 language
Itemgroups: Administrative, Tumor Assessment, Tumor Assessment , Baseline Melanoma Evaluation, Site and non-target lesions baseline evaluation, Target lesion(s) baseline evaluation, Target lesions
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics (Annex Report 2 Final)

- 10/27/20 - 1 form, 5 itemgroups, 18 items, 1 language
Itemgroups: Administrative, Informed Consent, Optional Translational Research and other Research, Demographics, Cutaneous Melanoma: Disease chracteristics
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia

- 10/7/20 - 1 form, 25 itemgroups, 85 items, 1 language
Itemgroups: Administrative, Coeliac disease, Coeliac disease - Signs and Symptoms, Coeliac disease - Other signs and symptoms, Coeliac disease - Other signs and symptoms , Coeliac disease - Diagnostic Test Results, Coeliac disease - Other Diagnostic Test Results , Coeliac disease - Other Diagnostic Test Results , Coeliac disease - Other diagnostic Procedure, Antiphospholipid Syndrome, Antiphospholipid Syndrome - Signs and symptoms (supporting the final diagnosis), Antiphospholipid Syndrome - Other Signs and symptoms, Antiphospholipid Syndrome - Other Signs and symptoms , Antiphospholipid Syndrome - Diagnostic Test Results, Antiphospholipid Syndrome - Other Diagnostic Test Results , Antiphospholipid Syndrome - Other Diagnostic Test Results , Antiphospholipid Syndrome - Other diagnostic Procedure , Autoimmune Haemolytic Anaemia, Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis), Autoimmune Haemolytic Anaemia - Other Signs and symptoms , Autoimmune Haemolytic Anaemia - Other Signs and symptoms , Autoimmune Haemolytic Anaemia - Diagnostic Test Results , Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results , Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results , Autoimmune Haemolytic Anaemia - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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