KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

NCT04165070 | Recruiting Phase 1 FDA Drug

• 6 other identifiers: 3475-01AMK-3475-01AKEYMAKER-U01A2023-506932-33-00U1111-1294-64742020-001626-56
• Study Type: interventional
• Target: 450
• Locations: 9 countries
• Sites: 46

Brief Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (4)

• Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be reported.

  Up to approximately 24 months

• Part B: Number of Participants Who Experience One or More Adverse Events (AEs)

  An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.

  Up to approximately 27 months

• Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE)

  An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be reported.

  Up to approximately 24 months

• Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

  A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT per CTCAE 5.0 will be reported.

  Up to approximately 3 Weeks

Secondary Outcomes (11)

• Part A: Progression-Free Survival (PFS) According to RECIST 1.1

  Up to approximately 24 months

• Part A: Number of Participants Who Experience One or More AEs

  Up to approximately 27 months

• Part A: Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 24 months

• Part B: ORR per RECIST 1.1 as assessed by blinded independent central review (BICR)

  Up to approximately 24 months

• Part B: Duration of Response (DOR) per RECIST 1.1 as assessed by BICR

  Up to approximately 24 months

Study Arms (11)

Part A: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg intravenously (IV) PLUS vibostolimab IV PLUS carboplatin Area Under the Concentration-Time Curve (AUC) 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Biological: Vibostolimab

Part A: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Biological: Vibostolimab

Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Biological: Boserolimab

Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS pemetrexed 500 mg/m\^2 IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Biological: Boserolimab

Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Biological: MK-4830

Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Biological: MK-4830

Part A: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Biological: MK-0482

Part A: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Biological: Pembrolizumab; Drug: Carboplatin; Biological: MK-0482

Part B: Pembrolizumab + I-DXd

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants with squamous and nonsquamous NSCLC will receive pembrolizumab 200 mg IV for up to 2 years, PLUS I-DXd in escalating doses until progressive disease or toxicity.

Biological: Pembrolizumab; Biological: Ifinatamab Deruxtecan (I-DXd)

Part B: Pembrolizumab + Carboplatin + I-DXd

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS I-DXd IV in escalating doses until PD or toxicity.

Biological: Pembrolizumab; Drug: Carboplatin; Biological: Ifinatamab Deruxtecan (I-DXd)

Part B: Pembrolizumab + Carboplatin + HER3-DXd

EXPERIMENTAL

On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS HER3-DXd IV in escalating doses until PD or toxicity.

Biological: Pembrolizumab; Drug: Carboplatin; Biological: HER3-DXd

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, SCH 900475, KEYTRUDA®

Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel; Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed; Part A: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed; Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed; Part B: Pembrolizumab + Carboplatin + HER3-DXd; Part B: Pembrolizumab + Carboplatin + I-DXd; Part B: Pembrolizumab + I-DXd

Carboplatin DRUG

IV infusion

Also known as: PARAPLATIN®

Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel; Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed; Part A: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed; Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed; Part B: Pembrolizumab + Carboplatin + HER3-DXd; Part B: Pembrolizumab + Carboplatin + I-DXd

Paclitaxel DRUG

IV infusion

Also known as: ABRAXANE®

Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel

Pemetrexed DRUG

IV infusion

Also known as: ALIMTA®

Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed; Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed

Vibostolimab BIOLOGICAL

IV infusion

Also known as: MK-7684

Part A: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel; Part A: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed

Boserolimab BIOLOGICAL

IV infusion

Also known as: MK-5890

Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel; Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed

MK-4830 BIOLOGICAL

IV infusion

Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed

MK-0482 BIOLOGICAL

IV Infusion

Part A: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel; Part A: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed

Ifinatamab Deruxtecan (I-DXd) BIOLOGICAL

IV infusion

Also known as: DS-7300a, MK-2400

Part B: Pembrolizumab + Carboplatin + I-DXd; Part B: Pembrolizumab + I-DXd

HER3-DXd BIOLOGICAL

IV Infusion

Also known as: U3-1402, MK-1022

Part B: Pembrolizumab + Carboplatin + HER3-DXd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
• Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy
• Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
• Has not received prior systemic treatment for their metastatic NSCLC
• Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B

You may not qualify if:

• Has a diagnosis of small cell lung cancer
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
• Has an active infection requiring systemic therapy
• Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure
• Has a known history of human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded
• Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization
• Has had major surgery \<3 weeks before the first dose of study treatment
• Is expected to require any other form of antineoplastic therapy while on study
• Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications
• Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis
• Has preexisting neuropathy that is moderate in intensity

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (46)

Banner MD Anderson Cancer Center ( Site 0001)

Gilbert, Arizona, 85234, United States

COMPLETED

City of Hope ( Site 0014)

Duarte, California, 91010, United States

COMPLETED

UCSF Medical Center at Mission Bay ( Site 0007)

San Francisco, California, 94158, United States

COMPLETED

Georgetown University ( Site 0036)

Washington D.C., District of Columbia, 20007, United States

COMPLETED

University of Kentucky Markey Cancer Center ( Site 0019)

Lexington, Kentucky, 40536-0293, United States

COMPLETED

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, 21237, United States

COMPLETED

Massachusetts General Hospital ( Site 0003)

Boston, Massachusetts, 02114, United States

COMPLETED

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts, 02215, United States

COMPLETED

Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

Omaha, Nebraska, 68130, United States

COMPLETED

Dartmouth Hitchcock Medical Center ( Site 0016)

Lebanon, New Hampshire, 03766, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

Hackensack, New Jersey, 07601, United States

COMPLETED

Laura and Isaac Perlmutter Cancer Center ( Site 0034)

New York, New York, 10016, United States

COMPLETED

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota, 58102, United States

RECRUITING

Cleveland Clinic Main ( Site 0006)

Cleveland, Ohio, 44195, United States

COMPLETED

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)

Columbus, Ohio, 43210, United States

RECRUITING

Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota, 57104, United States

RECRUITING

The University of Texas MD Anderson Cancer Center ( Site 0009)

Houston, Texas, 77030, United States

RECRUITING

Petz Aladar Megyei Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, 9024, Hungary

COMPLETED

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

COMPLETED

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

Budapest, 1121, Hungary

COMPLETED

Soroka Medical Center ( Site 0072)

Beersheba, 8457108, Israel

COMPLETED

Rambam Health Care Campus-Oncology ( Site 0076)

Haifa, 3109601, Israel

COMPLETED

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, 9103102, Israel

RECRUITING

Meir Medical Center ( Site 0071)

Kfar Saba, 4428132, Israel

COMPLETED

Rabin Medical Center ( Site 0074)

Petah Tikva, 4941492, Israel

COMPLETED

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, 5262000, Israel

RECRUITING

Sourasky Medical Center ( Site 0077)

Tel Aviv, 6423906, Israel

COMPLETED

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Firenze, 50134, Italy

COMPLETED

IRCCS Ospedale San Raffaele ( Site 0171)

Milan, 20132, Italy

COMPLETED

Policlinico Gemelli di Roma ( Site 0174)

Roma, 00168, Italy

COMPLETED

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

Warsaw, Masovian Voivodeship, 02-781, Poland

COMPLETED

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship, 80-952, Poland

COMPLETED

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

COMPLETED

Seoul National University Bundang Hospital ( Site 0081)

Seongnam-si, Kyonggi-do, 13620, South Korea

COMPLETED

Severance Hospital ( Site 0080)

Seoul, 03722, South Korea

COMPLETED

Samsung Medical Center ( Site 0082)

Seoul, 06351, South Korea

COMPLETED

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

COMPLETED

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, 28223, Spain

COMPLETED

Changhua Christian Hospital ( Site 0181)

Changhua, 50006, Taiwan

RECRUITING

Taipei Medical University Hospital ( Site 0180)

Taipei, 110301, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

Taoyuan District, 33305, Taiwan

RECRUITING

COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

Rivne, Rivne Oblast, 33010, Ukraine

RECRUITING

Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed; patritumab deruxtecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Only participants in Part A will be randomized.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 15, 2019
• Study Start: December 19, 2019
• Primary Completion (Estimated): February 13, 2032
• Study Completion (Estimated): February 13, 2032
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IL (7); PL (3); HU (3); US (18); IT (3); KR (3); TW (3); UA (4); ES (2)