chufangao/CTO huggingface dataset:
Clinical trial NCT05144984: A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Official title: Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 500.0 (ACTUAL)
Number of arms: 10.0
Start date: 2021-11-29
Primary completion date: 2023-02-13
Completion date: 2023-03-23
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04422392: Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer
Official title: Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer: A Randomized Phase II Study
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: since the CheckMate816 study is published in NEJM, enrolling patients becomes difficult
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-13
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Clinical trial NCT04256148: ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study is withdrawn due to the global impact of the COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-07-31
Primary completion date: 2022-10-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT04730206: The DAWN Antivirals Trial for Ambulatory COVID-19 Patients
Official title: The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
Acronym: DAWN
Sponsor: KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: recruitment was too slow
Enrollment: 44.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-15
Primary completion date: 2022-07-13
Completion date: 2022-07-13
Clinical trial NCT04788459: Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers
Official title: A Phase I/II Study to Assess the Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers
Sponsor: Takis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.
Enrollment: 68.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-02-25
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Clinical trial NCT04640194: A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19
Official title: The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19
Acronym: TRISTARDS
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-12-16
Primary completion date: 2022-07-19
Completion date: 2022-07-25
Baseline population: The Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint of interest.
Limitations and caveats: Results for the invasive mechanical ventilation (IMV) patients were only analyzed descriptively due to insufficient enrolled patients. For the All-Cause Mortality endpoint, the non-invasive mechanical ventilation (NIV) arm did not have enough events to perform the adjusted statistical model, instead the unadjusted model is presented for this endpoint.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT03589768: Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
Official title: A Phase II Double-Blind Trial to Evaluate the Safety, Immunogenicity and Effect on Infant Immune Responses of a Single Dose of Tdap in Pregnant Women in Mali
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 399.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-24
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Baseline population: Population includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.
Clinical trial NCT04863339: Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
Official title: Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Challenges in recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-31
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD time frame: 12 to 24 months following publication
IPD access criteria: Requests for IPD can be made by email and will be reviewed by the PI. The study protocol and deidentified data can be provided for scientific analyses performed by physicians and researchers affiliated with academic institutions.
Clinical trial NCT02788019: Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
Official title: Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to complete the sample size needed for 80% power due to changes in surgical approach to adductor block usage.
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-26
Primary completion date: 2020-03-23
Completion date: 2020-03-23
Baseline population: The study was terminated for failure of enrollment prior to reaching 34 participants in each group.
Clinical trial NCT02554812: A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
Official title: A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)
Enrollment: 409.0 (ACTUAL)
Number of arms: 19.0
Start date: 2015-11-09
Primary completion date: 2023-03-23
Completion date: 2023-03-23
Baseline population: The safety analysis set included all participants who received at least one dose of study drug.
Limitations and caveats: For combination C and D the level of clinical activity observed in Cohorts C11 to C13 and D11 to D32 did not support development beyond Phase 1b. For combination F, the level of clinical activity did not warrant further enrolment. Therefore, Phase 2 was not planned.
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 NCT03938337: Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer
Official title: Clinical Trial of Abemaciclib in Combination With Pembrolizumab in Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor terminated study due to higher incidence of pulmonary toxicity than expected, including death
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-08
Primary completion date: 2020-04-03
Completion date: 2020-04-03
Baseline population: study terminated prematurely due to toxicity from other trials with this combination
Plan to share individual participant data: YES
IPD sharing description: To Be Determined
IPD time frame: As long as study record is posted on CT.gov
IPD access criteria: To Be Determined
Clinical trial NCT04116632: A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Official title: A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-30
Primary completion date: 2020-02-10
Completion date: 2020-02-10
Clinical trial NCT05270460: Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis
Official title: A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina GEBT in Patients With Moderate to Severe Gastroparesis
Acronym: MOMENTUM
Sponsor: Processa Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-09
Primary completion date: 2022-09-29
Completion date: 2022-10-06
Plan to share individual participant data: NO
Clinical trial NCT02457910: Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Official title: A Phase Ib/II Trial of Taselisib (GDC-0032), a PI3K Inhibitor, in Combination With Enzalutamide in Patients With Androgen Receptor Positive Triple Negative Metastatic Breast Cancer
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Interim analysis - toxicity
Enrollment: 30.0 (ACTUAL)
Number of arms: 7.0
Start date: 2015-06-30
Primary completion date: 2018-12-31
Completion date: 2022-08-08
Baseline population: ER/PR+ or TNBC AR+ women with breast cancer
Clinical trial NCT03115489: Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus
Official title: Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus- a Pilot Study
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Low eligibility of patients, no successful recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-04
Primary completion date: 2019-12-31
Completion date: 2021-05-18
Plan to share individual participant data: NO
Clinical trial NCT02864953: Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
Acronym: CHARM
Sponsor: Remedy Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Early completed to operational challenges and other strategic considerations, not for efficacy or safety reasons
Enrollment: 535.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-29
Primary completion date: 2023-08-18
Completion date: 2023-08-18
Baseline population: The Intent-to-treat (ITT) population included all randomized participants.
Limitations and caveats: Early termination of trial due to operational challenges and other strategic considerations, not for efficacy or safety reasons.
Plan to share individual participant data: NO
Clinical trial NCT04109482: Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.
Official title: A Phase 1/2, Open Label, Multicenter Trial to Assess the Safety and Efficacy of MB-102 in Patients With Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
Sponsor: Mustang Bio (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business reasons.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-17
Primary completion date: 2023-05-17
Completion date: 2023-05-17
Plan to share individual participant data: NO
Clinical trial NCT03500549: Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Official title: A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsor: Apellis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-14
Primary completion date: 2019-11-14
Completion date: 2020-08-13
Baseline population: The intent-to-treat (ITT) set included all randomized subjects.
Clinical trial NCT04063124: Senolytic Therapy to Modulate Progression of Alzheimer's Disease
Official title: Pilot Study to Investigate the Safety and Feasibility of Senolytic Therapy to Modulate Progression of Alzheimer's Disease (SToMP-AD)
Acronym: SToMP-AD
Sponsor: The University of Texas Health Science Center at San Antonio (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-14
Primary completion date: 2021-12-10
Completion date: 2023-01-30
Baseline population: Five participants enrolled in the intervention
Plan to share individual participant data: YES
IPD sharing description: All IPD that underlie results in a publication
IPD time frame: At study completion
IPD access criteria: Through journal publication
Clinical trial NCT02628626: A Study of Colesevelam in Fecal Incontinence
Official title: A Placebo Controlled Study of Colesevelam in Fecal Incontinence
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-30
Primary completion date: 2022-04-14
Completion date: 2022-04-14
Plan to share individual participant data: NO
Clinical trial NCT03715166: Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder
Official title: A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The 6-month efficacy analysis did not show any significant difference between bumetanide versus placebo in the treatment of ASD in the overall studied population. No unexpected safety concerns were identified.
Enrollment: 211.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-24
Primary completion date: 2021-09-13
Completion date: 2021-09-13
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT03960645: Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
Official title: A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-28
Primary completion date: 2022-07-21
Completion date: 2022-08-18
Baseline population: B/F/TAF: Safety analysis set included all adult participants who took at least 1 dose of study drug (B/F/TAF). Neonates: Safety analysis set included neonates who were born to women participating in the study and had been enrolled into the study as well.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT03437720: Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
Official title: A 52-week Double-blind, Randomized, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of SAR425899 for the Treatment of Non-alcoholic Steatohepatitis (NASH)
Acronym: Restore
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decision to cancel TRIAL, not related to safety concern.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-05-23
Primary completion date: 2021-08-25
Completion date: 2021-08-25
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT01905657: Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
Official title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 1034.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-08-09
Primary completion date: 2015-09-30
Completion date: 2020-09-30
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03138499: A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
Official title: Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
Acronym: CheckMate 812
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient enrollment.
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-26
Primary completion date: 2021-02-22
Completion date: 2021-02-22
Limitations and caveats: Due to a treatment paradigm shift and subsequent low enrollment, the Sponsor chose to terminate the study and consequently there is limited data. These reasons were unrelated to any adverse events (AEs) or safety concerns.~The sample size was smaller than expected, therefore, results should be interpreted with caution. PFS, CRR, and ORR outcomes should be interpreted with caution given large confidence intervals around medians and early study closure.