chufangao/CTO huggingface dataset:
Clinical trial NCT01625286: Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients
Official title: A Phase I/II Study of AZD5363 Combined With Paclitaxel in Patients With Advanced or Metastatic Breast Cancer. Comprising a Safety Run-In and a Placebo-controlled Randomised Expansion in ER+ve Patients Stratified by PIK3CA Mutation Status
Acronym: BEECH
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 148.0 (ACTUAL)
Number of arms: 4.0
Start date: 2012-10-03
Primary completion date: 2017-01-28
Completion date: 2022-10-03
Baseline population: All patients with data who were included in the full analysis set for Part A and the intention to treat analysis set in Part B'
Limitations and caveats: QoL, PK/PD \& efficacy response modelling were considered non-key secondary endpoints and not disclosed at this time. QoL data was limited and considered exploratory, PK/PD and modelling were not reported in CSR. Diarrhoea burden is reported with AEs
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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 deidentified 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 NCT05662332: A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Official title: A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes
Acronym: QWINT-1
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 795.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-14
Primary completion date: 2024-07-17
Completion date: 2024-07-17
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 United States (US) and European Union (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 NCT05313009: Tarlox and Sotorasib in Patients With KRAS G12C Mutations
Official title: A Phase Ib / II Trial of Tarloxotinib and Sotorasib in Patients With KRAS G12C Mutations
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study drug was discontinued by manufacturer for business reasons.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-07
Primary completion date: 2023-07-07
Completion date: 2023-12-31
Clinical trial NCT05171920: A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia
Official title: A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia (CARDEA-Plus)
Acronym: CARDEA-Plus
Sponsor: CalciMedica, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: lack of sufficient numbers of critically ill patients to enroll the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-24
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT03805360: The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
Official title: The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient enrollment
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-24
Primary completion date: 2020-01-10
Completion date: 2020-01-10
Clinical trial NCT02994433: NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits
Official title: NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: remaining visits and enrollment terminated due to the pandemic
Enrollment: 49.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-27
Primary completion date: 2020-02-28
Completion date: 2020-02-28
Clinical trial NCT05116917: Immunotherapy Combined With Radiation and Influenza Vaccine for Pancreatic Cancer.
Official title: Nivolumab, Ipilimumab and Radiation in Combination With Influenza Vaccine in Patients With Pancreatic Cancer (INFLUENCE)
Acronym: INFLUENCE
Sponsor: Herlev Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on the precpecified interim analysis the predictive probability was below 10% for the prespecified endpoint.
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-05
Primary completion date: 2023-10-19
Completion date: 2023-10-19
Plan to share individual participant data: NO
Clinical trial NCT03498313: Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality
Official title: Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality
Acronym: CLEAR-2
Sponsor: University of Illinois at Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-27
Primary completion date: 2021-05-09
Completion date: 2021-05-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03612466: A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
Official title: A Dose Finding Study of CycloSam® (153Sm-DOTMP) Combined With External Beam Radiotherapy to Treat High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone
Sponsor: Albert Einstein College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study withdrawn before any participants could be enrolled. Issues being able to effectively recruit participants into the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-31
Primary completion date: 2023-01-31
Completion date: 2024-09-30
Plan to share individual participant data: NO
Clinical trial NCT02056574: Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
Official title: Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms
Acronym: ENACT-2
Sponsor: NoNO Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-30
Primary completion date: 2019-11-30
Completion date: 2020-04-30
Clinical trial NCT02614859: Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients
Official title: Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)
Acronym: BIMET-1
Sponsor: Fox Chase Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-01
Primary completion date: 2020-01-24
Completion date: 2020-01-24
Baseline population: Participant in metformin and bicalutamide arm removed from study due to non-compliance
Plan to share individual participant data: NO
Clinical trial NCT05288283: Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
Official title: A Randomized, Double-blind, Placebo-controlled, Multisite, Phase 3 Study to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P) in Children and Adolescents With Epilepsy With Myoclonic-Atonic Seizures
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to a business decision.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-31
Primary completion date: 2023-09-28
Completion date: 2023-09-28
Plan to share individual participant data: NO
Clinical trial NCT02635061: Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer
Official title: A Phase 1b Study of the Selective HDAC6 Inhibitor ACY-241 in Combination With Nivolumab in Patients With Unresectable Non-Small Cell Lung Cancer
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-25
Primary completion date: 2024-01-22
Completion date: 2024-01-22
Plan to share individual participant data: NO
Clinical trial NCT03951623: The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients
Official title: The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523, a Syk Inhibitor in Adult Patients of Immune Thrombocytopenia: a Randomized, Double Blinded, Placebo Controlled Phase Ib Study
Sponsor: Hutchmed (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-12
Primary completion date: 2021-10-30
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT04449965: Povidone-Iodine Rinses in the Management of COVID-19
Official title: The Efficacy of Topical Povidone-Iodine Rinses in the Management of the Coronavirus Disease 2019 (COVID-19)
Sponsor: St. Paul's Hospital, Canada (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The site struggled with patient recruitment as we were not able to reach patients with COVID-19
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-19
Primary completion date: 2021-08-16
Completion date: 2021-08-16
Clinical trial NCT04046146: Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
Official title: Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
Acronym: NIR-ICG MRL
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-15
Primary completion date: 2020-03-15
Completion date: 2020-03-15
Plan to share individual participant data: YES
IPD sharing description: Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.
Clinical trial NCT03389893: Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis
Official title: Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis, Dupilumab Study
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to inability to meet accrual goals within the funding period.
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-25
Primary completion date: 2020-04-03
Completion date: 2020-09-09
Baseline population: Modified intent-to-treat (mITT): All participants who were randomized and have Staphylococcus aureus (S. aureus) abundance measured at Day 0 and Day 28.
Limitations and caveats: One randomized participant did not meet criteria to be in the modified intent-to-treat (mITT) population because they withdrew prior to Day 28. Ten participants had 23 modified visits due to the coronavirus disease 2019 (COVID-19) pandemic.
Clinical trial NCT04679194: Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT
Official title: Ph 1 Study of Escalating Single & Multiple Doses of Mana 312 (Multi Tumor-Associated Antigen T Cells) Administered to Adult Subjects With Acute Myeloid Leukemia or Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplant
Sponsor: Mana Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Product manufacturing
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-08
Primary completion date: 2023-03-28
Completion date: 2023-03-28
Plan to share individual participant data: NO
Clinical trial NCT04575558: HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19
Official title: A Randomized, Multi-institutional, Phase 2 Study of Hydroxichloroquine Plus Azithromycin for High Risk SARS-CoV-2 Positive Patients (COVID-19)
Acronym: HOPE_BRAZIL
Sponsor: Latin American Cooperative Oncology Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn due to lack of study centers interested in participating.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2020-09-01
Completion date: 2020-10-30
Plan to share individual participant data: NO
Clinical trial NCT04493099: Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML
Official title: A Phase 1/2 Study of Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The original sponsor was acquired by a new company and has elected to end funding for all Investigator Sponsored Trials (ISTs)
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-31
Primary completion date: 2020-10-12
Completion date: 2020-10-12
Clinical trial NCT05155020: A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
Sponsor: Akeso (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The clinical development strategy has been changed
Enrollment: 1.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-02-11
Primary completion date: 2022-08-05
Completion date: 2022-08-05
Plan to share individual participant data: NO
Clinical trial NCT04922021: An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-site, Proof of Concept Trial to Evaluate the Efficacy and Safety of LEO 138559 in Adult Subjects With Moderate to Severe Atopic Dermatitis (AD).
Sponsor: LEO Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-14
Primary completion date: 2022-06-02
Completion date: 2022-09-26
Plan to share individual participant data: YES
IPD sharing description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
IPD time frame: Data are available to request after results of the trial are available on leopharmatrials.com.
IPD access criteria: Data sharing is subject to approved scientifically sound research proposal and signed data sharing agreement.
Clinical trial NCT05121948: A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Official title: A Multicenter, Open-label, Phase 1a/b Study of HC-7366 in Subjects With Advanced Solid Tumors
Sponsor: HiberCell, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: sponsor decision
Enrollment: 35.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-02-23
Primary completion date: 2024-02-09
Completion date: 2024-03-01
Plan to share individual participant data: NO
Clinical trial NCT04369365: A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic
Official title: A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic
Sponsor: Medical University of Vienna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 74.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-27
Primary completion date: 2021-06-15
Completion date: 2021-06-15
Clinical trial NCT03816553: SHR-1210 in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer
Official title: SHR-1210, a Novel Anti-pd-1 Antibody, in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer: a Single-arm, Open Label, Multi-center, Phase II Study
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-19
Primary completion date: 2020-04-30
Completion date: 2022-08-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03266900: A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
Official title: A Pilot, Single-centre, Randomized, 5-year, Parallel-group, Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival
Acronym: RESECT
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Difficulties with accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-16
Primary completion date: 2021-10-04
Completion date: 2021-10-04
Plan to share individual participant data: NO
Clinical trial NCT03961815: Open-label Extension Study of Brazikumab in Crohn's Disease
Official title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)
Acronym: INTREPID OLE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2023-09-19
Completion date: 2023-09-19
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 NCT02033993: Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.
Official title: A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen.
Sponsor: Canadian Cancer Trials Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 199.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-03-11
Primary completion date: 2018-05-03
Completion date: 2020-10-28
Baseline population: ITT
Plan to share individual participant data: NO
Clinical trial NCT03912220: Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration
Official title: Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2023-05-01
Completion date: 2023-05-30
Plan to share individual participant data: NO
Clinical trial NCT03284424: Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)
Official title: A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-26
Primary completion date: 2020-07-29
Completion date: 2023-09-13
Baseline population: The analysis population consisted of all participants who received ≥1 dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf