chufangao/CTO huggingface dataset:
Clinical trial NCT04537923: A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
Official title: A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)
Acronym: SURPASS-6
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1428.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-10-19
Primary completion date: 2022-10-11
Completion date: 2022-11-01
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03825718: A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
Official title: A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
Sponsor: Hebei Yanda Ludaopei Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-17
Primary completion date: 2020-09-01
Completion date: 2020-12-01
Clinical trial NCT02483000: Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
Official title: Evaluation of Pretargeted Anti-CD20 Radioimmunotherapy Combined With BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-Cell Malignancies
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Closed early due to lack of funding
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-01
Primary completion date: 2019-11-17
Completion date: 2020-09-02
Clinical trial NCT04145193: Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC
Official title: A Phase 2, Open-label, Randomized, Multicenter, Platform Study of Novel Oncology Therapies in Combination With Adjuvant Chemotherapy in High-risk, Microsatellite-stable Colorectal Cancer (COLUMBIA-2)
Sponsor: MedImmune LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study withdrawn prior to enrollment due to changing standard of care landscape.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-10-01
Primary completion date: 2024-03-19
Completion date: 2024-03-19
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT02004782: Barretts oEsophageal Resection With Steroid Therapy Trial
Official title: Reduction in Symptomatic Oesophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Doubleblind, Placebo-controlled, Multicentre Trial.
Acronym: BERST
Sponsor: Western Sydney Local Health District (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: study abandoned
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-31
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Clinical trial NCT03907124: Clinical Utility of Pharmacogenomics of Psychotropic Medications
Official title: Clinical Utility of Pharmacogenomics of Psychotropic Medications
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: PI left institution prior to recruitment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-03
Primary completion date: 2021-07-09
Completion date: 2021-07-09
Plan to share individual participant data: NO
Clinical trial NCT04880564: A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies
Official title: An Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies
Sponsor: Curon Biopharmaceutical (Australia) Co Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decided that there was no benefit in the drug treatment and due to company change in landscape in the new year.
Enrollment: 7.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-07-28
Primary completion date: 2022-08-29
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT03484650: Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
Official title: Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
Sponsor: Carilion Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Lack of available resources to complete study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-14
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Plan to share individual participant data: NO
IPD sharing description: No data to be shared.
Clinical trial NCT02910752: CLAM Chemotherapy With PBSC Support for Relapsed Patients After Allogeneic Stem Cell Transplantation
Official title: Salavge Chemotherapy With Cladribine, Cytarabine and Mitoxantrone Followed by Mobilized Peripheral Stem Cell Infusion From the Original Donor for Relapsed Patients After Allogeneic Stem Cell Transplantation: Phase I/II Study
Sponsor: Shanghai Jiao Tong University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Low enrollment
Enrollment: 20.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2016-09-30
Primary completion date: 2023-09-30
Completion date: 2023-09-30
Plan to share individual participant data: NO
Clinical trial NCT03953612: The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Official title: The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-12
Primary completion date: 2023-05-08
Completion date: 2023-05-08
Clinical trial NCT02586155: Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
Official title: A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE)
Acronym: BETonMACE
Sponsor: Resverlogix Corp (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2425.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-30
Primary completion date: 2020-11-30
Completion date: 2021-06-21
Baseline population: Of the initial 1215 participants randomized into the High-Intensity statin therapy+RVX000222 group, 3 were randomized in error. Of the initial 1210 participants randomized into the High-Intensity statin therapy+placebo group, 4 were randomized in error.
Plan to share individual participant data: NO
Clinical trial NCT05160168: A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Official title: A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Sponsor: Theseus Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The Sponsor terminated the study due to early dose-limiting toxicities.
Enrollment: 32.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-01-03
Primary completion date: 2024-02-02
Completion date: 2024-02-02
Baseline population: No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study.
Limitations and caveats: The Sponsor made a business decision to terminate the trial early due to observed dose limiting toxicities at dose levels that are below the target THE-630 exposure (set by preclinical studies) required for pan KIT variant inhibition in GIST patients. Therefore, several of the outcome measures could not be evaluated.
Plan to share individual participant data: NO
Clinical trial NCT04927247: A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated due to poor accrual and associated recrutiment challenges
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-09
Primary completion date: 2023-11-24
Completion date: 2023-11-24
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05870059: Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
Official title: Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
Sponsor: Ziauddin University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 102.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-02
Primary completion date: 2022-07-04
Completion date: 2022-11-16
Plan to share individual participant data: NO
IPD sharing description: it was written in the consent form that no information regarding patients will be shared to anyone in any case considering the ethics.
Clinical trial NCT04842630: A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Official title: An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: R\&d strategy adjustment
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-08
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Clinical trial NCT04186988: [18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy
Official title: Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy
Sponsor: University of California, Davis (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Unable to recruit to study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-05
Primary completion date: 2020-03-12
Completion date: 2020-03-12
Clinical trial NCT04450004: Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
Official title: A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age
Sponsor: Medicago (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 9.0
Start date: 2020-07-10
Primary completion date: 2020-09-20
Completion date: 2021-08-30
Plan to share individual participant data: NO
Clinical trial NCT03751007: A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)
Official title: A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)
Sponsor: Precigen Actobio T1D, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-10-24
Primary completion date: 2021-10-13
Completion date: 2021-10-13
Clinical trial NCT05017246: Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
Official title: A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 110.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-18
Primary completion date: 2024-07-17
Completion date: 2024-08-29
Plan to share individual participant data: NO
Clinical trial NCT04152863: Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)
Official title: A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 85.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-05
Primary completion date: 2023-07-12
Completion date: 2023-07-12
Limitations and caveats: This study was terminated due to the sponsor's development decision.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02545049: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
Acronym: FIGARO-DKD
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 7352.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-17
Primary completion date: 2021-02-02
Completion date: 2021-02-02
Baseline population: Full analysis set (FAS): the FAS comprised all randomized participants (except those with critical GCP violations).
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Clinical trial NCT04676087: Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides
Official title: Mogamulizumab and Extracorporeal Photopheresis (ECP) for the Treatment of Sézary Syndrome and Erythrodermic Mycosis Fungoides, a Phase 1b/2 Study
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of funding
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-21
Primary completion date: 2023-10-11
Completion date: 2023-10-11
Clinical trial NCT03905525: Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
Official title: A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)
Acronym: TWINSS
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 273.0 (ACTUAL)
Number of arms: 8.0
Start date: 2019-10-01
Primary completion date: 2022-09-28
Completion date: 2023-06-06
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT05081518: A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
Official title: Interventional, Randomized, Double-blind, Crossover, Placebo-controlled, Multiple-dose Lu AG06466 Phase 1 B Study in Patients With Focal Epilepsy Using EEG and PSG to Investigate Its Pharmacodynamic Effects on Prolonged Period of Inter- Icterical Spikes, Sleep and Neuroinflammation
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to enrolment challenges
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-29
Primary completion date: 2022-04-14
Completion date: 2022-04-14
Clinical trial NCT05238207: A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Official title: A Phase Ia/Ib Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BBI-001 in Iron Deficient Volunteers and HH Patients
Sponsor: Bond Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Only Part A (single dosing) was conducted due to business considerations
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-28
Primary completion date: 2023-05-04
Completion date: 2023-05-04
Plan to share individual participant data: NO
Clinical trial NCT04690855: A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer
Official title: A Multi-institutional Phase II Study to Evaluate Efficacy and Safety of TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer
Acronym: TARA
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study has been terminated due to Lack of Accrual.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-04
Primary completion date: 2022-02-18
Completion date: 2022-12-20
Plan to share individual participant data: NO
Clinical trial NCT05061251: Surgical Window of Opportunity Study of Orally Administered BAY 2402234 in Recurrent Glioma
Official title: An Open-Label Surgical Window of Opportunity Study Evaluating Pharmacodynamic Response of Orally Administered BAY 2402234 in Subjects With Recurrent Glioma, IDH Mutant, Grade 3 or 4
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Drug availability
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-01
Primary completion date: 2022-12-01
Completion date: 2023-12-01
Clinical trial NCT03769467: Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
Official title: An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy of Tabelecleucel in Combination With Pembrolizumab in Subjects With Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma
Sponsor: Atara Biotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Phase 1B part was completed with review of DLTs and cumulative safety data by Safety Data Review Committee and identification of a safe RP2D. Post-internal review, sponsor decided to terminate the study, and hence, Phase 2 part was not conducted.
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-19
Primary completion date: 2021-08-19
Completion date: 2021-08-19
Plan to share individual participant data: NO