chufangao/CTO huggingface dataset:
Clinical trial NCT04423367: Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment
Official title: Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial
Acronym: BID-PERAL
Sponsor: Institute of Hematology & Blood Diseases Hospital, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Did not meet the anticipated outcome.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-13
Primary completion date: 2024-01-31
Completion date: 2024-02-06
Plan to share individual participant data: NO
Clinical trial NCT03961048: Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Official title: Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Change in hospital protocol
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-23
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
Clinical trial NCT02400242: Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma
Official title: A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 85.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-05-07
Primary completion date: 2024-06-03
Completion date: 2024-06-03
Clinical trial NCT04730349: A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
Official title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)
Acronym: PIVOT IO 020
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 15.0 (ACTUAL)
Number of arms: 13.0
Start date: 2021-06-03
Primary completion date: 2022-06-22
Completion date: 2022-06-22
Limitations and caveats: On 14-Apr-2022, a joint decision was made to end the clinical development program for bempegaldesleukin in combination with nivolumab, resulting in the termination of this study. This results disclosure report provides analyses from CA045-020 Part A safety analyses only. Part B of the study (expansion phase) did not enroll any participants.
Clinical trial NCT04951609: A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy
Official title: A Short-term Exploratory Study to Evaluate Safety, Tolerability and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to SSRI Monotherapy and Psychotherapy
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-02
Primary completion date: 2024-04-08
Completion date: 2024-04-08
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04345848: Preventing COVID-19 Complications With Low- and High-dose Anticoagulation
Official title: Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
Acronym: COVID-HEP
Sponsor: University Hospital, Geneva (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low recruitement
Enrollment: 160.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-28
Primary completion date: 2021-06-02
Completion date: 2021-06-02
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02799368: Balanced Salt Solution Versus 0.9% Saline Infusion for Prevention of Contrast-induced Acute Kidney Injury (BASIC Trial)
Official title: A Randomized, Open Label, Active Control, 2 Parallel Groups, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Balanced Salt Solution Versus 0.9% Saline in Patients With High Risk of Contrast Induced Nephropathy.
Sponsor: Seoul National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 493.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2019-05-31
Completion date: 2020-03-31
Plan to share individual participant data: NO
Clinical trial NCT05154630: Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors
Official title: Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancies
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The sponsor has decided to terminate this study based on the current clinical research status of dual antibody drugs and full communication with the investigators.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-14
Primary completion date: 2023-03-31
Completion date: 2023-06-30
Clinical trial NCT02605993: Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Official title: A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-01-04
Primary completion date: 2017-02-23
Completion date: 2022-01-12
Baseline population: Safety set: All participants who received at least 1 dose of ravulizumab.
Clinical trial NCT04625725: Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.
Acronym: PROVENT
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 5197.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-11-21
Primary completion date: 2022-08-16
Completion date: 2023-12-08
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 NCT04158700: A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer
Official title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-05
Primary completion date: 2023-05-11
Completion date: 2023-05-11
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 NCT03964051: Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
Official title: Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
Sponsor: Odense University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Finished
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-01
Primary completion date: 2020-12-21
Completion date: 2020-12-21
Clinical trial NCT05465590: A Phase 1 Study to Evaluate Paclitaxel Conjugated CXC Receptor 4 Antagonist (MB1707) in Patients With Advanced Cancer
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of MB1707 in Patients With Advanced Cancer
Sponsor: Mainline Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The study was terminated due to Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-31
Primary completion date: 2024-11-30
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05077969: Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients
Official title: A Virtual Phase 2 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Post-exposure Prophylaxis (PEP) for Newly-infected COVID-19 Patients
Sponsor: Leidos Life Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low recruitment
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-29
Primary completion date: 2022-06-28
Completion date: 2022-07-08
Limitations and caveats: The study was not able to enroll the requisite number of patients to evaluate the prespecified endpoints. As a result the study was halted prematurely.
Plan to share individual participant data: NO
IPD sharing description: It is not yet known if there will be a plan to make individual participant data (IPD) available.
Clinical trial NCT03822832: A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
Official title: Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 in Adult Patients With Moderate to Severe Atopic Dermatitis
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 51.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-12
Primary completion date: 2020-01-17
Completion date: 2020-07-22
Baseline population: Randomized set (RS): this patient set includes all patients who were randomized into the trial. It will be used for display of patient disposition, baseline and demographic characteristics, and patients with IPDs (Important Protocol Deviations).
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:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html 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 http://trials.boehringer-ingelheim.com/ 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 NCT03940690: Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
Official title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
Acronym: COATS-VEGF
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: awaiting results of interim analysis
Enrollment: 30.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2019-10-24
Primary completion date: 2024-11-30
Completion date: 2024-11-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04652700: Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection
Acronym: Impower-024
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 494.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-15
Primary completion date: 2023-08-04
Completion date: 2023-08-04
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04770467: A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
Official title: A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
Sponsor: Brii Biosciences Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-02-28
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Clinical trial NCT04211389: Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Official title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
Acronym: DERMIS-2
Sponsor: Arcutis Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 442.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-17
Primary completion date: 2020-11-23
Completion date: 2020-11-23
Plan to share individual participant data: NO
Clinical trial NCT02460367: Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer
Official title: A Phase 1b/2 Study of Tergenpumatucel-L (HyperAcute Lung) Immunotherapy in Combination With the IDO Pathway Inhibitor Indoximod and Docetaxel in Patients With Advanced Previously Treated Non-Small Cell Lung Cancer (NSCLS)
Sponsor: Lumos Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of enrollment and changing landscape of standard of care.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-31
Primary completion date: 2017-07-17
Completion date: 2021-01-13
Plan to share individual participant data: NO
Clinical trial NCT03201250: Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple Myeloma
Official title: A Phase I/II Study of the c-Met Inhibitor Cabozantinib as a Targeted Strategy to Reverse Resistance to the Proteasome Inhibitor Carfilzomib in Refractory Multiple Myeloma
Sponsor: University of Nebraska (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Phase I response to treatment was not as expected and the myeloma field in treatment has changed since initiating the study, so investigators felt the study should not be pursued into Phase II.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-21
Primary completion date: 2021-04-12
Completion date: 2021-04-12
Baseline population: We only included the 8 subjects that passed eligibility and were dosed.
Clinical trial NCT04313634: Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans
Official title: Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans: A Phase 2, Single-Center, 20-week, Open-Label, Randomized Controlled Trial.
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 74.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-09
Primary completion date: 2023-06-06
Completion date: 2023-06-06
Plan to share individual participant data: NO
Clinical trial NCT02577367: Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding
Official title: The Effect of Holding Tube Feeding When Administering Levothyroxine on the Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding
Sponsor: Maimonides Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lost interest in current study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-01
Primary completion date: 2020-04-08
Completion date: 2020-04-08
Plan to share individual participant data: NO
Clinical trial NCT05565092: Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease
Official title: A Phase 2a, Randomized, Open-Label Study to Evaluate Multiple Dosing Regimens of Subcutaneous ALXN1820 in Adult Participants With Sickle Cell Disease
Acronym: PHOENIX
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision to terminate program.
Enrollment: 2.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-02-22
Primary completion date: 2024-01-09
Completion date: 2024-01-09
Plan to share individual participant data: YES
IPD sharing description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Clinical trial NCT04516759: AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Acronym: ARCADIA
Sponsor: St George Street Capital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 170.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-12
Primary completion date: 2021-04-25
Completion date: 2021-05-12
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to deidentified individual participant data (IDP) that underlie the published clinical trial results.
IPD time frame: Requests for access to the data will be accepted beginning 6 months after article publication and will continue to be accepted for up to 5 years after publication.
IPD access criteria: Researchers must submit a methodologically sound research proposal to St George Street using the contact details provided on our website. See link below.
Clinical trial NCT03744663: Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Official title: A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding for uninsured subjects could not be realized and staffing after COVID hit was also a problem.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT02750514: An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)
Acronym: FRACTION-Lung
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The standard of care for the patient population changed and we were unable to accrue any longer.
Enrollment: 295.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-05-09
Primary completion date: 2020-01-29
Completion date: 2020-01-29
Limitations and caveats: This study was terminated early by sponsor for reasons unrelated to safety.
Clinical trial NCT02493361: Trial of pIL-12/MK-3475 in Metastatic Melanoma
Official title: An Open-label, Phase II, Multicenter Study of Enhancing Pembrolizumab Responses in Melanoma Through Intratumoral pIL-12 Electroporation
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-17
Primary completion date: 2018-04-26
Completion date: 2020-03-02
Limitations and caveats: Closed to enrollment earlier than expected due to high response rate in order to advance to phase 2b in proven PD1-refractory patients. A total of 24 patients were consented instead of the planned enrollment of 42 patients.
Plan to share individual participant data: NO