• 香港中環花園道3號冠君大廈4樓全層
  • 九龍尖沙咀彌敦道132號美麗華廣場A座1908-09室

隨著近年醫藥推陳出新,新藥大幅提升和延長癌症患者的存活率和存活期,癌症已由過往人人聞之色變的噩耗,漸漸演變成一種慢性疾病。不過,在醫療科技躍進的同時,癌細胞也悄悄起了變化,因應治療的方向作出反抗,與科研人員展開一場漫長的搏鬥。

目前,仍有不少癌症種類欠缺有效的治療方法,令醫護人員束手無策。要勝出這場搏鬥和繼續為癌症病人帶來希望,實有賴公衆和病人積極參與臨床試驗,加快新藥的研發步伐,讓醫護人員能夠利用新藥戰勝癌症。

什麽是臨床試驗?

研發新藥是一個漫長的過程。在研發前期,科研人員需要在實驗室内進行一連串複雜的研究及測試;在新藥推出市面之前,科研人員則需要透過臨床試驗,評估新藥應用在人類的效果。

所謂臨床試驗,是指在志願者身上進行藥物醫學測試。一方面,科研人員通過密切監測志願者的反應,驗證藥物的藥理、成效和安全性;另一方面,病人志願者亦可以透過臨床試驗,得到試用新藥物或新治療方法的機會。

臨床試驗五部曲

一般而言,藥物臨床試驗可分爲以下五個階段,尤以三期臨床試驗較常提及和招募較多病人。在香港,臨床試驗主要於兩大教學醫院——瑪麗醫院和威爾斯親王醫院進行。

 零期一期二期三期四期
目的評估藥物的安全性和在身體内的代謝情況探討藥物的藥理和安全性評估藥物在不同劑量下的效果和安全性比較新藥和傳統治療方案或安慰劑的療效和安全性評估藥物推出市場後,病人服食藥物的情況,包括藥物的長遠療效和副作用
招募對象以健康的成年人爲主,部分臨床試驗亦會招募病人參與以健康的成年人爲主,部分臨床試驗亦會招募病人參與以藥物相關的病人為主以藥物相關的病人為主正在服食該藥物的病人,或已經停藥的病人
招募人數數至數十人數至數十人數十至數百人數百至數千人不定

參加臨床試驗的好處

  • 病人有機會嘗試新的藥物或治療方法,為他們帶來一線生機。
  • 病人無須負擔藥物和治療的費用。
  • 醫護團隊會更緊密的跟進和觀察病人的情況,以掌握新藥的效用和風險。
  • 病人如不想繼續參與,可隨時選擇退出。
  • 推動新藥研發。

臨床試驗的限制

  • 參加臨床試驗的病人須符合特定條件,故未必所有病人都合資格參加。
  • 由於臨床試驗普遍採用雙盲隨機對照試驗,即參與者或研究醫生都不能選擇治療藥物的組別,因此病人未必一定能夠嘗試新的藥物或治療方法。
  • 由於醫護團隊需更緊密觀察病人的情況,因此病人需花費較多時間和精力,定期回診所或醫院接受檢查。
  • 由於新藥尚在研究當中,故病人需承受一定的風險或副作用。

以下三期臨床試驗現正於香港招募病人(表格更新自2019年11月28日):

研究題目參加條件試驗藥物量度指標了解更多
Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver CancerAdult Primary Hepatocellular Carcinoma|Advanced Adult Primary Liver Cancer|Recurrent Adult Primary Liver CancerDrug: sorafenib tosylate|Radiation: stereotactic body radiation therapyOverall survival (OS)|TTP|PFS|Grade 4 or 5 hepatic adverse events, grade 4 or 5 gastrointestinal AEs, grade 4 thrombocytopenia associated with any bleeding or grade 5 thrombocytopenia. All AEs must be definitely or probably related to protocol treatment and use CTCAE version 4.0|Health related quality of life assessments measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)|Quality adjusted survival defined as the weighted sum of different time in different health states added up to a total quality-adjusted survival time using EuroQol (EQ-5D)https://ClinicalTrials.gov/show/NCT03565354
Study of BGB-290 or Placebo in Patients With Advanced or Inoperable Gastric CancerAdvanced or Inoperable Gastric CancerDrug: BGB-290|Drug: PlaceboProgression free survival|Overall survival between treatment groups (BGB-290 versus placebo)|Progression free survival between treatment groups determined by investigator assessment|Progression free survival on subsequent treatment (PFS2)|Time to second subsequent treatment|Objective response rate by investigator assessment|Duration of response by investigator assessment|Time to response by investigator assessment|Incidence, nature and severity of adverse events between treatment groupshttps://ClinicalTrials.gov/show/NCT03529110
An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small-Cell Lung Cancer (NSCLC) Participants Who Have Progressed on CrizotinibALK+ Advanced NSCLCDrug: Brigatinib|Drug: AlectinibPFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1|Time to Intracranial Progression (iPD) as Assessed by BIRC per Modified RECIST v1.1|Overall Survival (OS)|Objective Response Rate (ORR) as Assessed by Investigator and BIRC per RECIST v1.1|Time to Response as Assessed by Investigator and BIRC|Duration of Response (DOR) as Assessed by BIRC|Intracranial Objective Response Rate (iORR) as Assessed by BIRC per Modified RECIST v1.1|Intracranial Duration of Response (iDOR) as Assessed by the BIRC per Modified RECIST v1.1|Health-Related Quality of Life (HRQOL) from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score|HRQOL from EORTC QLQ- Lung Cancer (LC) 13https://ClinicalTrials.gov/show/NCT03596866
Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical PatientsAnemia, Iron-Deficiency|Colorectal CancerDrug: iron isomaltoside(Monofer®)Preoperative change in hemoglobin concentration (g/dL)|Preoperative change in serum ferritin (mcg/L)|Units of red blood cells transfused in perioperative period|Duration of hospital stay (days)|Quality of recovery as measured by questionnaire (QoR-15(Chinese))|Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions|Rate of surgical complications|Days (alive and) at home within 30 days of surgery (DAH30)https://ClinicalTrials.gov/show/NCT03447769
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)Biliary Tract CarcinomaDrug: Pembrolizumab|Drug: Gemcitabine|Drug: Cisplatin|Drug: PlaceboProgression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)|Overall Survival (OS)|Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR|Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR|Number of Participants Who Experience One or More Adverse Events (AE)|Number of Participants Who Discontinued Study Intervention Due to an Adverse Eventhttps://ClinicalTrials.gov/show/NCT03875235
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)Biliary Tract NeoplasmsDrug: Durvalumab|Drug: PlaceboOverall survival|PFS according to RECIST 1.1 using investigator assessment|ORR according to RECIST 1.1 using investigator assessment|DoR according to RECIST 1.1 using investigator assessmenthttps://ClinicalTrials.gov/show/NCT03515837
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]Breast CancerDrug: Trastuzumab deruxtecan (DS-8201a)|Drug: Ado-trastuzumab emtansine (T-DM1)Progression-free survival (PFS) based on blinded independent central review (BICR)|Overall survival (OS)|Objective response rate (ORR) based on BICR and investigator’s assessment|Duration of response (DoR) based on BICR and investigator’s assessment|Clinical benefit rate (CBR)|Progression-free survival (PFS) based on investigator’s assessmenthttps://ClinicalTrials.gov/show/NCT03194893
Study of Nivolumab Versus Placebo in Participants With High-Risk Breast CancerBreast CancerBiological: nivolumab|Drug: paclitaxel (PTX)|Other: nivolumab placebo|Drug: anthracycline|Drug: cyclophosphamide|Drug: Endocrine Therapy|Procedure: SurgeryPathological Complete response (pCR) Pathological Complete response (pCR) Using the definition of ypT0/Tis ypN0|Event-Free Survival (EFS)|Overall Survival (OS)|Disease-free Survival (DFS)|Distant Metastasis-free survival (DMFS)|Pathological Complete Response (pCR) using the definition of ypT0ypN0|Pathological Complete Response (pCR) rate using the definition of ypT0/is|Objective Response Rate (ORR)|Breast Conserving Surgery (BCS) rate|Number of participants experiencing an adverse event (AE)|Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30)|Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5)https://ClinicalTrials.gov/show/NCT03969121
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast CancerBreast Cancer Female|Hormone Receptor Positive Malignant Neoplasm of BreastDrug: Palbociclib|Drug: Endocrine therapyPre-operative Endocrine Prognostic Index (PEPI Score)|EndoPredictâ„¢ EPclin Score|Clinical Response Rate|Ki67 change|pathological response rate|Breast conserving rate|Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment as Assessed by CTCAE v4.03https://ClinicalTrials.gov/show/NCT03052608
A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma [IMbrave150]Carcinoma, HepatocellularDrug: Atezolizumab|Drug: Bevacizumab|Drug: SorafenibOverall Survival (OS)|Progression Free Survival (PFS) as Determined by an Independent Review Facility (IRF) According to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1|Objective Response (OR) defined as complete response or partial response as determined by the Investigator according to RECIST V1.1|Progression Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1|Time to Progression (TTP) as Determined by an Investigator According to RECIST v1.1|Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1|OR defined as complete or partial response as Determined by an IRF According to RECIST v1.1|TTP as Determined by an IRF According to RECIST v1.1|DOR as Determined by an IRF According to RECIST v1.1|OR defined as complete or partial response, as Determined by an IRF According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST)|PFS as Determined by an IRF According to HCC mRECIST|TTP as Determined by an IRF According to HCC mRECIST|DOR as Determined by an IRF According to HCC mRECIST|Time to Deterioration (TTD) in Patient-Reported GHS/QoL, physical functioning, and role functioning, as determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score|PFS as determined by the investigator according to RECIST v1.1|Serum Concentration of Atezolizumab|Change from Baseline in Anti-Drug Antibodies (ADAs) to Atezolizumab|Percentage of Participants with Adverse Events|PFS as Determined by an IRF According to RECIST v1.1|OShttps://ClinicalTrials.gov/show/NCT03498716
Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)Carcinoma, HepatocellularBiological: pembrolizumab|Drug: placebo|Other: best supportive care (BSC)Overall Survival (OS)|Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Duration Of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Time To Progression (TTP) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Number of Participants Who Experienced At Least One Adverse Event (AE)|Number of Participants Who Discontinued Study Treatment Due to an AEhttps://ClinicalTrials.gov/show/NCT03690388
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLCCarcinoma, Non-Small-Cell LungDrug: Lorlatinib|Drug: CrizotinibProgression-free survival (PFS) based on blinded independent central review (BICR) assessment|Overall Survival (OS)|PFS based on Investigator’s assessment|Objective Response (OR) based on BICR and on Investigator’s assessments|Intracranial Objective Response (IC-OR) based on BICR assessment|Intracranial Time to Progression (IC-TTP) based on BIRC assessment|Duration of Response (DR) based on BIRC assessment|intracranial Duration of Response (IC-DR) based on BICR assessment|Time to Tumor Response (TTR) based on BIRC assessment|Intracranial Time to Tumor Response (IC-TTR) based on BICR assessment|PFS2 based on investigator’s assessment|Adverse Event (AE) as graded by NCI CTCAE v 4.03)|Laboratory abnormalities as graded by NCI CTCAE v 4.03)|Vital signs (blood pressure, pulse rate) and body weight|Electrocardiograms (ECG)|Echocardiograms or multigated acquisition scan (MUGA)|Ophthalmology|PRO as assessed by EORTC QLQ-C30, EORTC QLQ LC13, and EQ-5D-5L|Tumor tissue biomarkers|Peripheral blood cfDNA (circulating free Deoxyribonucleic acid) biomarkershttps://ClinicalTrials.gov/show/NCT03427814
A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer PatientsCarcinoma, Non-Small-Cell LungDrug: Durvalumab|Other: PlaceboProgression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in randomised patients|The efficacy of durvalumab treatment compared to placebo in terms of Overall Survival (OS) in randomised patients|The efficacy of durvalumab treatment compared to placebo in terms of proportion of patients alive at 24 months (OS24) from randomisation.|Objective Response Rate (ORR) assessed by BICR according to RECIST 1.1 in randomised patients|Duration of Response (DoR) assessed by BICR according to RECIST 1.1 in randomised patients|Proportion of patients alive and progression free from randomisation to second progression (PFS2) as defined by local standard clinical practice|Proportion of patients alive and progression free at 12 months from randomisation (PFS12) assessed by BICR according to RECIST 1.1 in randomised patients|Proportion of patients alive and progression free at 18 months from randomisation (PFS18) assessed by BICR according to RECIST 1.1.|Proportion of patients at time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 in randomised patients|Peak Plasma Concentration (Cmax) in randomised patients|Trough Concentration (Ctrough) in randomised patients|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|Detection of ADA neutralising antibodies titres for all randomised patients|IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome OS|IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome PFS|IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome ORR|Number of participants with abnormal findings with physical examination|vital sign (blood pressure [BP])|vital sign (pulse rate)|vital sign (temperature)|vital sign (respiration rate)|vital sign (12-lead electrocardiogram)|Change in Albumin (g/L)|Change in Alkaline phosphatase (U/L)|Change in Alanine aminotransferase (U/L)|Change in Aspartate aminotransferase (U/L)|Change in Amylase (U/L)|Change in Bicarbonate (mmol/L)|Change in Calcium (mmol/L)|Change in Chloride (mmol/L)|Change in Creatinine (μmol/L)|Change in Gamma glutamyltransferase (U/L)|Change in Glucose (mmol/L)|Change in Lactate dehydrogenase (U/L)|Change in Lipase (U/L)|Change in Magnesium (mmol/L)|Change in Potassium (mmol/L)|Change in Sodium (mmol/L)|Change in Total bilirubin (μmol/L)|Change in total protein (g/L)|Change in TSH (mIU/L)|Change in T3 free (reflex) (mIU/L)|Change in T4 free (reflex) (mIU/L)|Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L)|Change in Uric acid (mmol/L)|Change in absolute neutrophil count (/L)|Change in absolute lymphocyte count (/L)|Change in haemoglobin (g/L)|Change in platelet count (/L)|Change in total white blood cell count (/L)|Change in activated partial thromboplastin time|Change in international normalised ratio|Urinalysis: Change in bilirubin (μmol/L)|Urinalysis: Change in blood|Urinalysis: Change in color and apprearance|Urinalysis: Change in ketones (mmol/L)|Urinalysis: Change in pH|Urinalysis: Change in protein (g/L)|Urinalysis: Change in specific gravityhttps://ClinicalTrials.gov/show/NCT04034355
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical HysterectomyCervical CancerDrug: carboplatin|Drug: cisplatin|Drug: paclitaxelDisease-free survival|Overall survival|Chemotherapy-induced neuropathy as measured by FACT-GOG/NTX4|Quality of life as measured by FACT-Cx and FACIT-Dhttps://ClinicalTrials.gov/show/NCT00980954
Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus CarriersChronic Lymphocytic Leukemia|Indolent B-cell Lymphomas|Chronic Hepatitis B|Lymphoma, Small Lymphocytic|Mantle-Cell Lymphoma|Waldenstrom’s Macroglobulinaemia|Follicular LymphomaDrug: IbrutinibOverall response rate (ORR)|Duration of remission|Rates of HBV Reactivation while on Ibrutinib therapy|Adverse events and severe adverse eventshttps://ClinicalTrials.gov/show/NCT03654729
Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal CancerColorectal Cancer|Chemotherapy-induced Peripheral NeuropathyDrug: Calmangafodipir (5 µmol/kg)|Other: PlaceboTo compare PledOx versus Placebo with respect to the proportion of patients with moderate or severe chronic chemotherapy induced peripheral neuropathy|Proportion of patients with mild, moderate or severe chronic chemotherapy induced peripheral neuropathy|Sensitivity to touching cold items|Cumulative dose of oxaliplatin during chemotherapy|Vibration sensitivity on the lateral malleolus|Worst pain in hands or feet|Functional impairment (in the non-dominant hand)|Sustained efficacy on prevention of chemotherapy induced peripheral neuropathy during long-term follow-up|Disease free survival|Tolerability of PledOx as assessed by Adverse Events|Tolerability of PledOx as assessed by laboratory variables|Tolerability of PledOx as assessed by vital signs|Safety of PledOx as assessed by Adverse Events|Safety of PledOx as assessed by laboratory variables|Safety of PledOx as assessed by vital signshttps://ClinicalTrials.gov/show/NCT01730937
Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)Colorectal Cancer|Chemotherapy-induced Peripheral NeuropathyDrug: Calmangafodipir (2 µmol/kg)|Drug: Calmangafodipir (5 µmol/kg)|Drug: PlaceboModerate or severe chronic chemotherapy induced peripheral neuropathy (CIPN)|Mild, moderate or severe chronic chemotherapy induced peripheral neuropathy (CIPN)|Sensitivity to touching cold items|Cumulative dose of oxaliplatin during chemotherapy|Vibration sensitivity on the lateral malleolus|Worst pain in hands or feet|Functional impairment (in the non-dominant hand)|Sustained efficacy on prevention of CIPN during long-term follow-up|Overall response rate (ORR)|Progression-free survival (PFS)|Overall survival (OS)https://ClinicalTrials.gov/show/NCT03143153
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted TherapyDifferentiated Thyroid CancerDrug: Cabozantinib|Drug: PlaceboProgression Free Survival (PFS)|Objective Response Rate (ORR)https://ClinicalTrials.gov/show/NCT03623087
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell LymphomaDiffuse Large B-Cell LymphomaDrug: Polatuzumab Vedotin|Drug: Rituximab|Drug: Cyclophosphamide|Drug: Doxorubicin|Drug: Vincristine|Drug: Vincristine Placebo|Drug: Prednisone|Drug: Polatuzumab vedotin PlaceboProgression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma|Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)|Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma|Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma|Overall Survival|Percentage of Participants With CR as Assessed by FDG-PET by Investigator|Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma|Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma|Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma|Time to Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue|Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)|Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue|Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS|EORTC QLQ-C30 Treatment-Related Symptoms Score|Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score|Percentage of Participants With adverse Events (AEs)|Serum Concentration of Total Polatuzumab Vedotin|Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])|Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE|Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotinhttps://ClinicalTrials.gov/show/NCT02435433
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNAEpstein-Barr Virus Infection|Stage II Nasopharyngeal Carcinoma|Stage III Nasopharyngeal Carcinoma|Stage IVA Nasopharyngeal Carcinoma|Stage IVB Nasopharyngeal CarcinomaDrug: Cisplatin|Other: Clinical Observation|Drug: Fluorouracil|Drug: Gemcitabine Hydrochloride|Radiation: Intensity-Modulated Radiation Therapy|Other: Laboratory Biomarker Analysis|Drug: Paclitaxel|Other: Quality-of-Life AssessmentOverall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III)|Progression-free survival (PFS) (Detectable Plasma EBV DNA Cohort Phase II)|Changes in pure tone audiometry (Phase II and III)|Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III)|Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III)|Changes in quality of life (QOL) (general and physical well-being) assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP) (Phase II and III)|Cost effectiveness as assessed by the health-related QOL (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III)|Incidence of acute grade 3-5 adverse events (Phase II and III)|Incidence of death (Phase II and III)|Incidence of late grade 3-5 adverse events (Phase II and III)|OS (Detectable Plasma EBV DNA Cohort Phase II)|PFS (Undetectable Plasma EBV DNA Cohort Phase III)|Time to distant metastasis (DM) (Phase II and III)|Time to local progression (Phase II and III)|Time to regional progression (Phase II and III)https://ClinicalTrials.gov/show/NCT03178552
A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-FetoproteinHepatocellular CarcinomaDrug: Ramucirumab|Drug: PlaceboOverall Survival (OS)|Progression Free Survival (PFS)|Time to Radiographic Progression|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)|Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion|PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion|Percentage of Participants With Anti-Ramucirumab Antibodies|Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)|Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire|Time to Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS)https://ClinicalTrials.gov/show/NCT03631199
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer TherapyHepatocellular CarcinomaDrug: Cabozantinib|Drug: Sorafenib|Drug: AtezolizumabDuration of Progression Free Survival (PFS) for the experimental arm vs. the control arm|Duration of Overall Survival (OS) for the experimental arm vs. the control arm|Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control armhttps://ClinicalTrials.gov/show/NCT04109066
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative TreatmentHepatocellular CarcinomaDrug: Durvalumab|Drug: Bevacizumab|Other: PlaceboRecurrence-free survival (RFS) for Arm B vs Arm C|Recurrence-free survival (RFS) Arm A vs Arm C|Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C|Recurrence-free survival at 24 months (RFS24) for Arm A vs Arm C and Arm B vs Arm C|Recurrence-free survival at 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C|Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C|Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm Chttps://ClinicalTrials.gov/show/NCT03706690
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular CarcinomaHepatocellular CarcinomaDrug: Durvalumab|Drug: Bevacizumab|Other: Placebo|Procedure: Transarterial Chemoembolization (TACE)Progression Free Survival (PFS) for Arm A vs Arm C|Progression Free Survival (PFS) for Arm B vs Arm C|Overall Survival (OS)|Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)|Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)https://ClinicalTrials.gov/show/NCT03675737
Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)Hepatocellular CarcinomaBiological: Pembrolizumab|Drug: PlaceboRecurrence-Free Survival (RFS)|Overall Survival (OS)|Percentage of Participants who Experience an Adverse Event (AE)|Percentage of Participants who Discontinue Study Treatment due to an AE|Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score|Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score|Time to Deterioration (TTD) in the EORTC-QLQ-C30, Combined GHS / QoL Scale Score|Time to Deterioration (TTD) in the EORTC QLQ-HCC18 Scale Score|Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Scorehttps://ClinicalTrials.gov/show/NCT03143049
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular CarcinomaHepatocellular CarcinomaDrug: Nivolumab|Drug: Ipilimumab|Drug: Sorafenib|Drug: lenvatinibOverall Survival (OS)|Objective Response Rate (ORR)|Duration of Response (DOR)|Time to Symptom Deterioration (TTSD)https://ClinicalTrials.gov/show/NCT03755791
A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or AblationHepatocellular Carcinoma|Liver CancerBiological: Nivolumab|Other: PlaceboRecurrence-free Survival (RFS)|Overall Survival (OS)|Time to recurrence (TTR)https://ClinicalTrials.gov/show/NCT03299244
A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell LymphomaLymphoma, Mantle CellDrug: Acalabrutinib in combination with bendamustine and rituximab|Drug: Placebo in combination with bendamustine and rituximabProgression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2|Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2|Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2|IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2|Overall survival in Arm 1 compared to Arm 2|IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2|IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2https://ClinicalTrials.gov/show/NCT03217812
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL)Lymphoma, Non-HodgkinDrug: Copanlisib (BAY80-6946)|Drug: Placebo|Drug: Rituximab|Drug: Cyclophosphamide|Drug: Doxorubicin|Drug: Vincristine|Drug: Bendamustine|Drug: PrednisoneSafety run-in_Determination of the recommended Phase-III dose (RP3D) of copanlisib in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities / adverse events|Phase III_Evaluation whether copanlisib in combination with standard immunochemotherapy is superior to placebo and standard immunochemotherapy assessed by the prolongation of progression free survival (PFS)|Safety run-in_Best Overall Response (BOR)|Safety run-in_Number of participants with treatment-emergent adverse events|Phase III_Objective tumor response rate (ORR)|Phase III_Duration of tumor response (DOR)|Phase III_Complete tumor response rate (CRR)|Phase III_Time to tumor progression (TTP)|Phase III_Time to next anti-lymphoma treatment (TTNT)|Phase III_Overall survival (OS)|Phase III_Time to improvement in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaire|Phase III_Time to deterioration in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaire|Phase III_Number of participants with treatment-emergent adverse eventshttps://ClinicalTrials.gov/show/NCT02864251
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin’s Lymphoma (iNHL)Lymphoma,Non-HodgkinDrug: Copanlisib (BAY 80-6946)|Drug: Placebo|Drug: RituximabProgression free survival (PFS)|Objective tumor response|Duration of response (DOR)|Complete response|Time to progression (TTP)|Overall survival (OS)|Time to deterioration in DRS-P of at least 3 points as measured by the FLymSI-18 (Lymphoma Symptom Index -18)questionnaire|Number of participants with adverse Events as a measure of safety and tolerability|Time to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, will be evaluated for patients with a baseline DRS-P score of 30 points or lesshttps://ClinicalTrials.gov/show/NCT02163759
A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)Multiple MyelomaDrug: Velcade|Drug: Melphalan|Drug: Prednisone|Drug: DaratumumabVery Good Partial Response (VGPR) or Better Rate at 6 Month After Last Participant First Dose|Very Good Partial Response (VGPR) or Better Rate at 3 Years After Last Participant First Dose|Progression-Free Survival (PFS)|Time to Next Treatment|Overall Response Rate (ORR)|Complete Response Rate|Stringent Complete Response (sCR) Rate|Time to Response|Overall Survival (OS)|Duration of Response|Time to VGPR or Better Response|Duration of VGPR or Better Response|EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (QLQ-C30) Questionnaire|Number of Participants With Antibodies to Daratumumab|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability|Clinical Efficacy of D-VMP in High Risk Molecular Subgroupshttps://ClinicalTrials.gov/show/NCT02991638
A Roll Over Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive CancerNeoplasmsDrug: Alectinib|Drug: CrizotinibNumber of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest|Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters|Number and Causes of Death Occurring on Studyhttps://ClinicalTrials.gov/show/NCT03822507
SIMPLE Chemotherapy for NK Lymphoma/LeukaemiaNon-Hodgkin’s Lymphoma, Relapsed|Non-Hodgkin T-cell Lymphoma|Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeDrug: Cisplatin|Drug: Gemcitabine|Drug: Etoposide (VP-16)|Device: Ifosfamide|Drug: Dexamethasone|Drug: L-asparaginaseEfficacy as measured by overall response rate measured at the time of best response.|Adverse events and severe adverse events related to the treatment|Progression-free survival (PFS)|Overall survival (OS)https://ClinicalTrials.gov/show/NCT03937219
Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-ANon-Small Cell Lung CancerDrug: Canakinumab|Drug: PlaceboDisease Free Survival (DFS) by local investigator|Overall Survival (OS)|Lung Cancer Specific Survival (LCSS)|Serum concentration-time profiles of canakinumab and appropriate individual PK parameters based on population PK model|Serum concentrations of anti-canakinumab antibodies|Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire|Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 together withhttps://ClinicalTrials.gov/show/NCT03383458
Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)Non-small Cell Lung CancerBiological: pembrolizumab|Drug: pemetrexed|Drug: carboplatin|Drug: cisplatin|Drug: saline solutionProgression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Overall Survival (OS)|Objective Response Rate (ORR) Per RECIST 1.1|Duration of Response (DOR) Per RECIST 1.1|Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 Item (QLQ-C30) Global Health Status (Item 29) Scale Score|Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea|Adverse Events (AEs)|Study Treatment Discontinuations Due to AEs|Change from Baseline in EORTC-QLQ-C30 Quality of Life (Item 30) Scale Scorehttps://ClinicalTrials.gov/show/NCT03847428
A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerDrug: Alectinib|Drug: Atezolizumab|Drug: Pemetrexed|Drug: Cisplatin|Drug: Carboplatin|Drug: Gemcitabine|Drug: EntrectinibCohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1|Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the RECIST v1.1|Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on the RECIST v1.1|Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the RECIST v1.1|All Cohorts: Duration of Response as Assessed by the Investigator Based on the RECIST v1.1|Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on the RECIST v1.1|Cohorts A, B and D: PFS as Assessed by the Investigator Based on the RECIST v1.1|All Cohorts: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on the RECIST v1.1|Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on the RECIST v1.1|All Cohorts: PFS as Assessed by IRF Based on the RECIST v1.1|All Cohorts: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on the RECIST v1.1|All Cohorts: Overall Survival|All Cohorts: Percentage of Participants with Adverse Events|Cohorts A, B and D: Percentage of Participants who Have Shown Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain)|All Cohorts: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by SILC Scale|Cohort C: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale|All Cohorts: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – C30 (EORTC QLQ-C30)|Cohorts A, B and D: Change from Baseline in HRQoL Scores as Measured by the SILC Scale|All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30|Cohorts A, B and D: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale|All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire|Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)|Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib|Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib|Cohort B: Time to Reach Cmax (Tmax) of Alectinib|Cohort B: Half-Life (t1/2) of Alectinib|Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last|Cohort B: Metabolite to Parent Exposure Ratio for Cmax|Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on the RECIST v1.1|Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on the RECIST v1.1 at Months 6 and 12|Cohort D: Time to CNS progression as Assessed by the Investigator Based on the RECIST v1.1|Cohort D: Time to CNS progression as Assessed by the IRF Based on the RECIST v1.1|Cohort D: Intracranial Tumor Response Rate as Assessed by the Investigator Based on the RECIST v1.1|Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30|Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20|Cohort D: Mean Plasma Concentration of Entrectinib|Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5https://ClinicalTrials.gov/show/NCT03778957
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC SubjectsNon-small Cell Lung CancerDrug: canakinumab|Drug: canakinumab matching placebo|Drug: pembrolizumab|Drug: carboplatin|Drug: cisplatin|Drug: paclitaxel|Drug: nab-paclitaxel|Drug: pemetrexedSafety run-in part: Incidence of dose limiting toxicities (DLTs)|Double-blind, randomized, placebo-controlled part: Progression free survival (PFS) per investigator assessment using RECIST v1.1|Double-blind, randomized, placebo-controlled part: Overall survival (OS) per investigator assessment using RECIST v1.1|Safety run-in part: Overall response rate (ORR) per investigator assessment using RECIST v1.1|Double-blind, randomized, placebo-controlled part : Overall response rate (ORR) per investigator assessment using RECIST v1.1|Safety run-in part: Disease control rate (DCR) per investigator assessment using RECIST v1.1|Double-blind, randomized, placebo-controlled part : Disease control rate (DCR) per investigator assessment using RECIST v1.1|Safety run-in part: Duration of response (DOR) per investigator assessment using RECIST v1.1|Double-blind, randomized, placebo-controlled part : Duration of response (DOR) per investigator assessment using RECIST v1.1|Double-blind, randomized, placebo-controlled part only: Time to response (TTR) per investigator assessment using RECIST v1.1|Safety run-in part: Antidrug antibodies (ADA) of canakinumab|Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of canakinumab|Safety run-in part: Antidrug antibodies (ADA) of pembrolizumab|Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of pembrolizumab|Safety run-in part: Serum canakinumab concentration|Double-blind, randomized, placebo-controlled part : Serum canakinumab concentration|Safety run-in part: Serum pembrolizumab concentration|Double-blind, randomized, placebo-controlled part : Serum pembrolizumab concentration|Safety run-in part: Plasma pemetrexed concentration|Double-blind, randomized, placebo-controlled part : : Plasma pemetrexed concentration|Safety run-in part: Plasma cisplatin concentration|Double-blind, randomized, placebo-controlled part: Plasma cisplatin concentration|Safety run-in part: Plasma carboplatin concentration|Double-blind, randomized, placebo-controlled part: Plasma carboplatin concentration|Safety run-in part: Plasma paclitaxel concentration|Double-blind, randomized, placebo-controlled part: Plasma paclitaxel concentration|Double-blind, randomized, placebo-controlled part: Plasma nab-paclitaxel concentration|Double-blind, randomized, placebo-controlled part only :Time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea per QLQ-LC13 questionnaire|Double-blind, randomized, placebo-controlled part only: Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 questionnaire|Double-blind, randomized, placebo-controlled part only: change from baseline in score as per the EQ-5D-5L questionnairehttps://ClinicalTrials.gov/show/NCT04003636
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in NSCLC Patients With EGFR Mutation Who Failed 1L or 2L EGFR TKI TherapyNon-Small-Cell Lung CarcinomaBiological: Nivolumab|Biological: Ipilimumab|Drug: Pemetrexed|Drug: Cisplatin|Drug: CarboplatinProgression free survival (PFS) in participants with epidermal growth factor receptor (EGFR) mutation positive non-small cell lung carcinoma (NSCLC)|Overall survival (OS)|Objective response rate (ORR)|Duration of response (DOR)|Progression free survival (PFS) ratehttps://ClinicalTrials.gov/show/NCT01828489
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 YearsPediatric Acute Myeloblastic LeukemiaDrug: Randomisation course 1 mitoxantrone versus DaunoXome|Drug: Randomisation course 2 ADxE versus FLADxMinimal residual disease|Event-free survival|Acute toxicity|Long-term toxicity|Overall survivalhttps://ClinicalTrials.gov/show/NCT02135042
Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory MyelomaRelapse Multiple MyelomaDrug: PCD|Drug: PDProgression free survival (PFS)|Overall response rate (ORR)|Overall survival (OS)|Duration of response (DOR)|Number of Participants affected by Adverse Eventshttps://ClinicalTrials.gov/show/NCT02367040
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell CarcinomaRenal Cell CarcinomaDrug: Cabozantinib|Biological: Nivolumab|Biological: Ipilimumab|Drug: Cabozantinib-matched placeboDuration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC)|Duration of Overall Survival (OS)https://ClinicalTrials.gov/show/NCT03867084
A Study of NKTR-214 in Combination With Nivolumab Compared With the Investigator’s Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)Renal Cell Carcinoma|Metastatic Renal Cell CarcinomaBiological: Bempegaldesleukin|Drug: Sunitinib|Biological: Nivolumab|Drug: CabozantinibOverall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk patients|ORR per RECIST 1.1 by BICR in IMDC all-risk patients|Overall survival (OS) in IMDC intermediate- or poor-risk patients|OS in IMDC all-risk patients|Progression-free survival (PFS) by BICR in IMDC intermediate- or poor-risk patients|PFS by BICR in IMDC all risk-patients|Incidence of treatment-related Adverse Events (AEs)|ORR using RECIST 1.1 by investigator and in biomarker population|PFS by investigator and in biomarker population|OS in biomarker population|Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19)https://ClinicalTrials.gov/show/NCT03729245
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in AsiaSecondary HyperparathyroidismDrug: KHK7580|Drug: Cinacalcet HydrochlorideMean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period|Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period|Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period|Number of subjects achieving a mean percent decrease in intact PTH level of ≧30% (percent change ≦-30%) from baseline in the evaluation period|Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧30% (percent change ≦-30%) from baseline in the evaluation period|Intact PTH level|corrected serum Ca level|serum P levelhttps://ClinicalTrials.gov/show/NCT02972840
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian HD Subjects With SHPTSecondary Hyperparathyroidism|Chronic Kidney DiseaseDrug: Etelcalcetide|Drug: Cinacalcet>30% reduction predialysis serum PTH|> 50% reduction predialysis serum PTH|Percent change from baseline in mean predialysis serum cCa|Serum P ≤ 4.5 mg/dL during the EAPhttps://ClinicalTrials.gov/show/NCT03434379
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)Stomach NeoplasmsDrug: Pembrolizumab|Drug: Cisplatin|Drug: 5-fluorouracil|Drug: oxaliplatin|Drug: capecitabine|Drug: Placebo for PembrolizumabOverall Survival (OS)|Progression-free Survival (PFS)|Objective Response Rate (ORR)|Duration of Response (DOR)|Percentage of Participants Experiencing Adverse Events (AEs)|Percentage of Participants Discontinuing Study Drug Due to AEshttps://ClinicalTrials.gov/show/NCT03062358
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast CancerTriple Negative Breast CancerDrug: Atezolizumab|Drug: Paclitaxel|Drug: Dose-dense Doxorubicin or dose-dense Epirubicin|Drug: CyclophosphamideInvasive Disease-Free Survival (iDFS)|Overall Survival (OS)|Disease-Free Survival (DFS)|Recurrence-Free Interval (RFI)|Distant RFI|Percentage of participants with adverse events|Serum concentration of Atezolizumab|Invasive Disease-Free Survival (iDFS) in PDL1- Selected Patients|Invasive Disease-Free Survival (iDFS) in Node- Positive Disease|Invasive Disease Free Survival (iDFS) including second primary non-breast invasive cancer|Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab|Mean changes from baseline in patient-reported function (role, physical)|Mean changes from baseline in patient-reported health-related quality of life (HRQoL)https://ClinicalTrials.gov/show/NCT04039607
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1)Ulcerative ColitisDrug: Adalimumab|Other: Adalimumab Placebo|Drug: Etrolizumab|Other: Etrolizumab PlaceboPercentage of Participants With Induction of Remission With Etrolizumab Compared With Placebo at Week 10, as Determined by the Mayo Clinic Score (MCS)|Percentage of Participants With Induction of Remission With Etrolizumab Compared With Adalimumab at Week 10, as Determined by the MCS|Percentage of Participants With Induction of Clinical Remission at Week 10, as Determined by the MCS|Percentage of Participants With Clinical Response at Week 10, as Determined by the MCS|Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, as Determined by the Mayo Endoscopic Subscore|Percentage of Participants With Endoscopic Remission at Week 10, as Determined by the Mayo Endoscopic Subscore|Percentage of Participants who Achieve Remission at Week 10 and who Maintained Remission to Week 14, as Determined by the MCS|Percentage of Participants With Histological Remission at Week 10, as Determined by the Nancy Histological Subscore|Change from Baseline in MCS Rectal Bleeding Subscore at Week 6|Change from Baseline in MCS Stool Frequency Subscore at Week 6|Change From Baseline in Ulcerative Colitis (UC) Bowel Movement Signs and Symptoms at Week 10, as Assessed by UC-Participant-Reported Outcome Signs and Symptoms (PRO/SS)|Change From Baseline in UC Abdominal Symptoms at Week 10, as Assessed by UC-PRO/SS|Change From Baseline in Health-Related Quality of Life (QOL) at Week 10, as Assessed by Overall Inflammatory Bowel Disease Questionnaire (IBDQ)|Pharmacokinetics of Etrolizumab: Serum Concentration|Percentage of Participants With at Least One Adverse Event by Severity, According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0)|Percentage of Participants With at Least One Serious Adverse Event|Percentage of Participants With Adverse Events Leading To Study Drug Discontinuation|Percentage of Participants With Infection-Related Adverse Events by Severity, According to NCI CTCAE v4.0|Percentage of Participants With Serious Infection-Related Adverse Events|Percentage of Participants With Injection-Site Reactions by Severity, According to NCI CTCAE v4.0|Percentage of Participants With Hypersensitivity Reaction Events by Severity, According to NCI CTCAE v4.0|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Etrolizumab|Percentage of Participants With Laboratory Abnormalitieshttps://ClinicalTrials.gov/show/NCT02626455
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus CisplatinVarious Advanced CancerBiological: Nivolumab|Biological: Ipilimumab|Drug: Cisplatin|Drug: FluorouracilOverall survival (OS)|Progression-free Survival (PFS)|Objective Response Rate (ORR)https://ClinicalTrials.gov/show/NCT03274492

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