chufangao/CTO huggingface dataset:
Clinical trial NCT03176537: Periodontal Profile of Hypogonadic Men
Official title: Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men
Sponsor: Universidade Federal do Paraná (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No eligible participants for the RCT were found
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-01
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT04784442: A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia
Sponsor: Otsuka Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 188.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-03-24
Primary completion date: 2022-04-18
Completion date: 2022-05-17
Baseline population: For the full analysis set (FAS), a total of 186 subjects (45 for the 60 mg group, 46 for the 120 mg group, and 48 for the 180 mg group were included in the ETC-1002 group, and 47 subjects were included in the placebo group).
Plan to share individual participant data: YES
IPD sharing description: : Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
IPD access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Clinical trial NCT03449524: PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
Official title: Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
Acronym: PAH
Sponsor: Complexa, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: LOE
Enrollment: 69.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-01
Primary completion date: 2020-08-05
Completion date: 2020-08-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03614052: Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy
Official title: Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
Sponsor: Pontificia Universidad Catolica de Chile (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Problems with the number of participants
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-01
Primary completion date: 2020-01-26
Completion date: 2020-01-26
Clinical trial NCT03727724: Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer
Official title: Phase II Single Arm Study of Afatinib in Combination With Cetuximab in EGFR Exon 20 Insertion Positive Non-small-cell Lung Cancer
Acronym: AFACET
Sponsor: The Netherlands Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 37.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-04
Primary completion date: 2022-09-06
Completion date: 2022-09-06
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04044170: Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Official title: A Phase 2 Study of Poziotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Exon 20 Mutation in China and Korea
Sponsor: Hanmi Pharmaceutical Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study termination by the Sponsor
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-30
Primary completion date: 2020-04-13
Completion date: 2020-04-13
Clinical trial NCT03079102: Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest
Official title: Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest
Acronym: iNOOHCA
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrollment and planned change of institution by PI
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-26
Primary completion date: 2020-05-22
Completion date: 2020-06-02
Limitations and caveats: Planned Echocardiogram data was not able to be collected due to technical and feasibility constraints.~Laser speckle contrast imaging data still requires validation and is therefore not reported.~CPC-extended data was incomplete across many domains and therefore is not reported.
Plan to share individual participant data: NO
Clinical trial NCT02780128: Next Generation Personalized Neuroblastoma Therapy
Official title: Next Generation Personalized Neuroblastoma Therapy (The NEPENTHE Trial)
Acronym: NEPENTHE
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The goals of Part 1 (molecular screening) were met, but lack of therapies to match molecular aberrations made Part 2 (treatment) no longer feasible.
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-31
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Clinical trial NCT04145219: House Dust Mite Allergy Trial In Children
Official title: A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
Acronym: MATIC
Sponsor: ALK-Abelló A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1460.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-12
Primary completion date: 2023-04-01
Completion date: 2023-04-21
Baseline population: All randomized and treated participants
Plan to share individual participant data: NO
Clinical trial NCT04139993: RBX7455 Before Surgery for the Treatment of Operable Breast Cancer
Official title: A Pilot Trial of Preoperative Oral Microbiota-Based Investigational New Drug, RBX7455 to Target Immune Response in Patients With Operable Stage I-III Breast Cancer
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: poor accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-08-31
Primary completion date: 2023-01-11
Completion date: 2023-01-11
Clinical trial NCT02043899: A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma
Official title: A Cancer Research UK Phase I/II Study to Compare [124I]Meta-Iodobenzylguanidine (mIBG) Positron Emission Tomography/Computerised Tomography (PET/CT) to [123I]mIBG Imaging in Patients With Metastatic Neuroblastoma
Sponsor: Cancer Research UK (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-02-28
Primary completion date: 2020-10-15
Completion date: 2020-10-15
Limitations and caveats: An exact one-sided binomial test of the null hypothesis: p ≤90% was performed using α=0.05 on the \[124I\]mIBG PET/CT imaging assessments with SIOPEN consensus scores.
Plan to share individual participant data: NO
Clinical trial NCT04491604: Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
Official title: A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously KB103) for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)
Acronym: GEM-3
Sponsor: Krystal Biotech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-17
Primary completion date: 2021-10-29
Completion date: 2022-01-14
Baseline population: Safety Population
Plan to share individual participant data: NO
Clinical trial NCT03909594: Bubiket Study: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone
Official title: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone in Patients With Hip or Femur Fracture: a Double Blind Randomized Clinical Trial (BupiKet)
Sponsor: Maimonides Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The COVID Pandemic delayed start of study and currently the investigators are not interested in conducting the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-01
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT03836001: A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
Official title: A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-18
Primary completion date: 2021-12-06
Completion date: 2022-06-24
Limitations and caveats: The primary limitation of the study is the small sample size due to the rarity of EB, the COVID-19 pandemic-related disruptions, and limited drug availability.
Plan to share individual participant data: NO
Clinical trial NCT04625517: Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)
Official title: Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-22
Primary completion date: 2022-06-15
Completion date: 2022-06-15
Clinical trial NCT03823131: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat
Official title: The Trifecta Study: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Treatment Ineffective
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-02
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Baseline population: The safety and efficacy analysis population is defined as all enrolled subjects who received at least one dose of study treatment.
Limitations and caveats: The study closed earlier than expected during enrollment into Arm A. Arm B and Arm C were never opened to accrual.
Plan to share individual participant data: NO
Clinical trial NCT04346355: Efficacy of Early Administration of Tocilizumab in COVID-19 Patients
Official title: An Open-label Randomized Multicenter Study to Evaluate the Efficacy of Early Administration of Tocilizumab (TCZ) in Patients With COVID-19 Pneumonia
Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on interim analysis for futility and given an enrolment rate almost nil
Enrollment: 126.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-31
Primary completion date: 2020-06-06
Completion date: 2020-06-06
Clinical trial NCT04345367: Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Official title: A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 727.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-11
Primary completion date: 2021-07-13
Completion date: 2021-07-13
Baseline population: Safety Analysis Set comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
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 NCT03801031: Sexual Dysfunction in Gynecologic Oncology Patients
Official title: Sexual Dysfunction in Gynecologic Oncology Patients
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-06
Primary completion date: 2021-11-03
Completion date: 2021-11-03
Limitations and caveats: This study stopped accrual early due to unmet targeted accrual goals with 4 subjects accrued out of 120 planned.
Plan to share individual participant data: NO
Clinical trial NCT03867370: Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma
Official title: A Phase Ib/II, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Neoadjuvant Toripalimab Injection (JS001) or Toripalimab in Combination With Lenvatinib for Patients With Resectable Hepatocellular Carcinoma (HCC)
Sponsor: Shanghai Junshi Bioscience Co., Ltd. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Enrollment is over, the study was completed
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-26
Primary completion date: 2023-08-08
Completion date: 2023-08-08
Clinical trial NCT04129151: Palbociclib + Ganitumab In Ewing Sarcoma
Official title: Phase 2 Trial of Palbociclib and Ganitumab in Patients With Relapsed or Refractory Ewing Sarcoma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study closed early due to discontinuation of ganitumab supply.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-05
Primary completion date: 2022-12-15
Completion date: 2022-12-15
Limitations and caveats: The study terminated before full accrual.
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: contact Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT03629275: Investigation of Neural Stem Cells in Ischemic Stroke
Official title: A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects With Disability Following an Ischemic Stroke
Acronym: PISCES III
Sponsor: ReNeuron Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic decision to progress stroke disability programme through regional partnerships
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-31
Primary completion date: 2020-09-09
Completion date: 2021-03-02
Clinical trial NCT03364270: TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study
Official title: An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis
Acronym: K5-C200
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-10
Primary completion date: 2020-02-28
Completion date: 2020-05-31
Limitations and caveats: Small sample size Differences in the time between imaging and symptoms of stroke or transient ischemic attack
Clinical trial NCT05065411: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
Official title: P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib
Acronym: VERU-024
Sponsor: Veru Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-11
Primary completion date: 2023-10-19
Completion date: 2024-01-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03526588: Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)
Official title: Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Competing randomized trial of an experimental therapy limited initial enrollment. The trial was completed, published, and the experimental therapy became broadly desired. Given this, the investigators felt it best to terminate this competing study.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-01
Primary completion date: 2022-07-01
Completion date: 2024-07-01
Clinical trial NCT03615040: Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP)
Official title: A Randomised Placebo-controlled Trial of Anti-ST2 in COPD (COPD-ST2OP)
Acronym: COPD-ST2OP
Sponsor: University of Leicester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-11
Primary completion date: 2020-05-29
Completion date: 2020-12-31
Limitations and caveats: * Small sample size (n=81) at a single site, therefore not powered to detect a reduction in exacerbation frequency that was observed.~* Participants were required to have had a minimum of 2 exacerbations in the previous 12 months, so the findings are not representative for a wider clinical population.~* In response to COVID-19, collection of secondary/exploratory outcomes were reduced, with spirometry and sputum induction discontinued.
Plan to share individual participant data: NO
Clinical trial NCT03630770: Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Official title: Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Sponsor: Women and Infants Hospital of Rhode Island (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-05
Primary completion date: 2017-11-29
Completion date: 2021-11-02
Plan to share individual participant data: NO
Clinical trial NCT05621525: Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
Official title: A Phase I, Open Label, Dose Escalation and Expansion, Two- Part Study of SHP-2 Inhibitor BBP-398 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-cancer Activity in Chinese Subjects With Advanced Solid Tumors
Sponsor: LianBio LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business reason
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-10-18
Primary completion date: 2024-03-29
Completion date: 2024-03-29
Clinical trial NCT03642132: Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)
Official title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Phase 3 B9991010 study was stopped due to futility of efficacy at interim analysis on 21Dec2018, and approvals of PARP inhibitors in front-line maintenance setting, Pfizer decided stopping enrollment in the B9991030 study on 19Mar2019.
Enrollment: 79.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-19
Primary completion date: 2021-12-22
Completion date: 2021-12-22
Baseline population: The baseline analysis population included all randomized participants who received at least 1 dose of study drug (avelumab, talazoparib, bevacizumab, carboplatin, paclitaxel).
Limitations and caveats: As of 19 March 2019, the sponsor decided to stop enrollment/randomization in the study. A total of 104 participants were screened and 79 participants completed screening and randomized in the study before study discontinuation. As only 11% projected enrollment was met at the time of enrollment stop, the original study endpoints are no longer applicable and/or feasible; only the Safety, PK and Immunogenicity Analysis were done and these data are included in this report.
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 NCT03631641: Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy
Official title: A Phase II Study of PD-1 Inhibition for the Prevention of Colon Adenomas in Patients With Lynch Syndrome and a History of Partial Colectomy
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-04
Primary completion date: 2021-01-25
Completion date: 2021-01-25
Limitations and caveats: Trial stopped early due to withdrawal of pharmaceutical sponsor support
Plan to share individual participant data: NO
Clinical trial NCT02543749: DC Vaccination in CML
Official title: Dendritic Cells as Autologous Vaccine in Patients With Chronic Myeloid Leukemia
Sponsor: Charite University, Berlin, Germany (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-07-31
Primary completion date: 2022-07-31
Completion date: 2022-07-31