DISITAMAB VEDOTIN for Urothelial carcinoma

Inclusion criteria

• {"criterion_text":"- Age 18 years and older at the time of consent or considered an adult by local regulations"}
• {"criterion_text":"- The following baseline laboratory data, laboratory values collected within 7 days prior to randomization are acceptable: a.\tHb ≥9 g/dL without transfusion b.\tANC ≥1.5 × 109/L c.\tPlatelet count ≥100 × 109/L d.\tALT and AST ≤2.5 × upper limit of normal (ULN) without liver metastases or ≤5 × ULN with liver metastases e.\tSerum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin >1.5 × ULN; serum total bilirubin ≤3 × ULN for subjects with Gilbert's syndrome f.\tCrCl ≥30 mL/min, as calculated using the Cockcroft-Gault formula g.\tInternational normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Subjects receiving anticoagulant therapy are eligible and are required to have INR/PT and aPTT within therapeutic range. Note: In subjects transfused before the study, the transfusion (such as red blood cell, whole blood, or plasma transfusion) must be ≥14 days prior to start of therapy to establish adequate laboratory parameters independent from transfusion support"}
• {"criterion_text":"- Subjects of childbearing potential (as defined in Section 10.4) under the following conditions: a.\tMust have a negative serum pregnancy test (minimum sensitivity 25 mIU/mL or equivalent units of beta human chorionic gonadotropin [β-hCG]) result within 72 hours prior to the first dose of study intervention. Subjects with false positive results and documented verification that the subject is not pregnant are eligible for participation. b.\tMust agree not to try to become pregnant during the study and for at least 2 months after the final dose of disitamab vedotin and 4 months after the final dose of pembrolizumab, and 6 months after the final dose of cisplatin, carboplatin, and gemcitabine. c.\tMust agree not to breastfeed or donate ova, from the time of informed consent and continuing through 2 months after the final dose of disitamab vedotin and 4 months after the final dose of pembrolizumab, and 6 months after the final dose of cisplatin, carboplatin, and gemcitabine. d.\tIf sexually active in a way that could lead to pregnancy, must consistently use at least 2 acceptable methods of birth control (contraception), at least one of which must be highly effective (as defined in Section 10.4) starting at time of informed consent and continuing through at least 2 months after the final dose of disitamab vedotin and 4 months after the final dose of pembrolizumab, and 6 months after the final dose of cisplatin, carboplatin, and gemcitabine."}
• {"criterion_text":"- Subjects who can get someone pregnant (as defined in Section 10.4) under the following conditions: a.\tMust agree not to donate sperm from the time of informed consent and continuing through at least 4 months after the final dose of disitamab vedotin and 6 months after the final dose of cisplatin, carboplatin, and gemcitabine. b.\tIf sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use at least 2 acceptable methods of birth control (contraception), at least 1 of which must be highly effective (as defined in Section 10.4) from the time of informed consent and continuing through at least 4 months after the final dose of disitamab vedotin and 6 months after the final dose of cisplatin, carboplatin, and gemcitabine. c.\tIf sexually active with a person who is pregnant or breastfeeding, must consistently use a condom (as defined in Section 10.4) from the time of informed consent and continuing through at least 4 months after the final dose of disitamab vedotin and 6 months after the final dose of cisplatin, carboplatin, and gemcitabine."}
• {"criterion_text":"- The subject must provide documented informed consent."}
• {"criterion_text":"- Subject must be willing and able to comply with the trial procedures and the follow-up schedule."}
• {"criterion_text":"- Subjects must have LA/mUC with histopathological confirmation (Stage IIIB-IV per American Joint Committee on Cancer, Cancer Staging Atlas 8th ed.), including UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial (transitional cell histology) carcinoma is the predominant cell type."}
• {"criterion_text":"- Subjects must have measurable disease by investigator assessment according to RECIST v1.1. Note: Subjects with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy."}
• {"criterion_text":"- Subjects must not have received prior systemic therapy for locally advanced or metastatic UC with the following exceptions: a.\tNeoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of therapy"}
• {"criterion_text":"- Subjects must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, per the investigator’s evaluation. Subjects meeting any of the following criteria should be considered cisplatin ineligible, and will receive carboplatin: a.\tCrCl <60 mL/min but ≥30 mL/min within 7 days of randomization (measured by the Cockcroft-Gault formula). Note: Subjects with a CrCl ≥50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator’s clinical judgment. b.\tECOG performance status of 2 within 7 days of randomization (refer to Inclusion Criterion 8 for additional criteria for ECOG 2 subjects). c.\tNCI CTCAE Grade 2 or higher hearing loss. Note: If a subject is determined to be cisplatin eligible, gemcitabine and cisplatin are to be administered without exception."}
• {"criterion_text":"- Subjects must be willing and able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks (or, alternatively, freshly sectioned slides; see laboratory manual for details) from a muscle-invasive or metastatic UC lesion or a biopsy sample of metastatic UC. This must be obtained prior to study treatment initiation and will be sent to a sponsor designated central laboratory for biomarker analysis. If archival tissue is not available, then a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days prior to Cycle 1 Day 1. Biopsy must provide adequate tissue for HER2 testing. a.\tTumor tissue recommended to be collected within 12 months prior to enrollment, and after completion of the most recent (neo) adjuvant systemic therapy"}
• {"criterion_text":"- HER2 expression of 1+ or greater on IHC determined by central laboratory"}
• {"criterion_text":"- An ECOG performance status score of 0, 1, or 2 within 7 days prior to randomization. a.\tSubjects with ECOG 2 must meet additional criteria: Hb ≥10 g/dL, CrCl ≥50 mL/min, and heart failure severity less than New York Heart Association (NYHA) Class III."}
• {"criterion_text":"- Adequate baseline cardiac parameters: a.\tLVEF ≥50% b.\tFridericia’s corrected QT interval (QTcF) <470 ms"}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab"}
• {"criterion_text":"- Subject has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study intervention, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study intervention. Subjects must have recovered from all radiation-related toxicities and must not require corticosteroids. Note: Ongoing hormonal/antihormonal treatment (eg, for breast cancer) is allowed, provided that the subject is eligible per exclusion criteria of prior malignancy"}
• {"criterion_text":"- Subjects who previously received treatment with an MMAE agent or anti-HER2 therapy"}
• {"criterion_text":"- Ongoing sensory or motor neuropathy Grade 2 or higher"}
• {"criterion_text":"- Subjects with acute, chronic, or symptomatic infections, including: a.\tOngoing symptomatic severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) infection except for subjects who have recovered clinically but continue to have a detectable presence of SARS-CoV-2. b.\tHistory of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by local regulations. c.\tHistory of hepatitis B virus (HBV) infection (defined as positive for HBV surface antigen) or known active hepatitis C virus (HCV) infection (defined as HCV RNA [qualitative] is detected). Subjects who have been curatively treated for hepatitis C infection are permitted if they have documented sustained virologic response of ≥12 weeks. HBV negative DNA of ≥12 weeks is also allowed. No HBV or HCV testing is required, unless mandated by local regulations or institutional standard"}
• {"criterion_text":"- Has a diagnosis of immunodeficiency condition/disorder (ie, immunoglobulin A [IgA] deficiency, etc.) or is receiving chronic systemic steroid therapy (dose >10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug"}
• {"criterion_text":"- Subjects with history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, noninfectious pneumonitis, interstitial lung disease, or idiopathic pneumonitis are excluded. Subjects with current pneumonitis or interstitial lung disease are also excluded"}
• {"criterion_text":"- Subjects with a history of another invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. a.\tSubjects with adequately resected early-stage non-melanoma skin cancer or carcinoma in situ are allowed. b.\tSubjects with a history of prostate cancer (T2NXMX or lower with Gleason score ≤7) treated with definitive intent (surgically or with radiation therapy), provided that the subject is considered prostate cancer free and the following criteria are met: \tSubjects who have undergone an adequate surgical resection must have undetectable prostate specific antigen (PSA) for ≥1 year and at screening. \tSubjects who have had radiation must have a PSA doubling time >1 year (based on at least 3 values determined >1 month apart) and a total PSA value that does not meet Phoenix criteria for biochemical recurrence (ie, <2.0 ng/mL above nadir). \tSubjects with untreated low-risk prostate cancer (Gleason score ≤6) on active surveillance with PSA doubling time >1 month (based on at least 3 values determined <1 month apart) are also eligible. c.\tMalignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or radical treatment of ductal carcinoma in situ to the breast)."}
• {"criterion_text":"- Uncontrolled cardiac disease including: a.\tCardiac failure – NYHA Class III or IV heart failure (see Section 10.5) b.\tCardiac arrhythmia – Grade 2 or higher arrhythmia or heart block c.\tCardiac ischemia – unstable angina within the past 12 months, myocardial infarction or cerebral infarction within the past 6 months, etc. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, any other structural heart disease interventions. d.\tHypertension: Subjects with CTCAE Grade 3, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite adequate medical intervention will be excluded. Subjects with hypertension adequately controlled at baseline may be enrolled into the study. e. Unexplained syncope, symptomatic hypotension, or asymptomatic hypotension with systolic blood pressure <90 mmHg"}
• {"criterion_text":"- Subjects who have received radiotherapy within 2 weeks prior to randomization"}
• {"criterion_text":"- Subjects who have received major surgery within 4 weeks prior to randomization. Subject must have recovered adequately from complications from the study intervention prior to randomization"}
• {"criterion_text":"- History of severe/life threatening irAE with PD-(L)1 inhibitors are excluded. Please consult with medical monitor. a.\tGrade ≥3 pneumonitis IMAEs, cardiomyopathy, etc. b.\tGrade 4 diarrhea/colitis IMAEs, hepatitis IMAEs, rash IMAEs c.\tGrade 3/4 adrenal insufficiency, hypophysitis, uveitis, hypothyroidism"}
• {"criterion_text":"- Subjects requiring chronic oxygen therapy or have Grade ≥3 pulmonary disease unrelated to underlying malignancy"}
• {"criterion_text":"- Subjects who have received a live or live-attenuated vaccine within 30 days prior to randomization"}
• {"criterion_text":"- Subjects who are pregnant or breastfeeding women"}
• {"criterion_text":"- Other serious underlying medical condition, psychiatric or substance abuse disorder that, in the opinion of the investigator, would impair the subject’s ability to receive or tolerate the planned treatment, or comply with the requirements of the study and follow-up"}
• {"criterion_text":"- Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes"}
• {"criterion_text":"- CNS and/or leptomeningeal metastasis. a.\tSubjects with treated CNS metastases (by whole brain radiation therapy, surgery or radiosurgery, etc.) are permitted on study if all of the following are met: b.\tCNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis. c.\tSubject is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks"}
• {"criterion_text":"- History of or active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). a.\tReplacement therapy (eg, thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic disease-modifying treatment and is allowed. b.\tSubjects with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy are allowed. c.\tSubjects requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections are allowed. d.\tSubjects with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome are allowed."}
• {"criterion_text":"- Subjects who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded"}
• {"criterion_text":"- Subjects with prior solid organ or bone marrow transplantation"}
• {"criterion_text":"- Pleural effusion or ascites with symptoms or requiring symptomatic treatment"}
• {"criterion_text":"- Subjects with an estimated life expectancy <12 weeks"}
• {"criterion_text":"- Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1 or returned to baseline, except for Grade 2 alopecia"}

Primary endpoints

• {"endpoint_text":"- PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by blinded independent central review (BICR)","definition_or_measurement_approach":"Progression-free survival (PFS) as assessed by RECIST v1.1 using blinded independent central review (BICR)"}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) — time from randomization to death from any cause"}

Secondary endpoints

• {"endpoint_text":"- ORR per RECIST v1.1 by BICR","definition_or_measurement_approach":"Objective response rate (ORR) assessed by RECIST v1.1 via blinded independent central review (BICR)"}
• {"endpoint_text":"- ORR per RECIST v1.1 by investigator assessment","definition_or_measurement_approach":"Objective response rate (ORR) assessed by RECIST v1.1 via investigator assessment"}
• {"endpoint_text":"- DOR per RECIST v1.1 by BICR","definition_or_measurement_approach":"Duration of response (DOR) per RECIST v1.1 as assessed by BICR"}
• {"endpoint_text":"- DOR per RECIST v1.1 by investigator","definition_or_measurement_approach":"Duration of response (DOR) per RECIST v1.1 as assessed by investigator"}
• {"endpoint_text":"- DCR per RECIST v1.1 by BICR","definition_or_measurement_approach":"Disease control rate (DCR) per RECIST v1.1 assessed by BICR"}
• {"endpoint_text":"- DCR per RECIST v1.1 by investigator","definition_or_measurement_approach":"Disease control rate (DCR) per RECIST v1.1 assessed by investigator"}
• {"endpoint_text":"- PFS per RECIST v1.1 by investigator","definition_or_measurement_approach":"Progression-free survival (PFS) per RECIST v1.1 as assessed by investigator"}
• {"endpoint_text":"- Type, incidence, relatedness, severity, and seriousness of adverse events (AEs)","definition_or_measurement_approach":"Safety: adverse events characterised by type, incidence, relatedness, severity and seriousness (per CTCAE)"}
• {"endpoint_text":"- Type, incidence, and severity of laboratory abnormalities","definition_or_measurement_approach":"Laboratory safety endpoints: laboratory abnormality type, incidence, and severity"}
• {"endpoint_text":"- Treatment discontinuation rate due to AEs","definition_or_measurement_approach":"Proportion of subjects discontinuing treatment because of adverse events"}
• {"endpoint_text":"- Electrocardiogram abnormalities, including changes in QTc","definition_or_measurement_approach":"ECG monitoring including QTc changes (QTcF)"}
• {"endpoint_text":"- Effect on left ventricular ejection fraction","definition_or_measurement_approach":"Left ventricular ejection fraction (LVEF) measurements to detect changes from baseline"}
• {"endpoint_text":"- Change from baseline to Week 16 in European Organisation for Research and Treatment of Cancer core QoL questionnaire (EORTC QLQ C30) Global Health Status (GHS)/QoL Score (Items 29+30)","definition_or_measurement_approach":"Change in EORTC QLQ-C30 Global Health Status / QoL (items 29+30) from baseline to Week 16"}
• {"endpoint_text":"- Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score (Items 29 + 30)","definition_or_measurement_approach":"Time from baseline to clinically meaningful deterioration in EORTC QLQ-C30 GHS/QoL score (items 29+30)"}
• {"endpoint_text":"- Time to pain progression","definition_or_measurement_approach":"Time to progression of pain measured by standard pain assessments"}

Methods

• Advocacy outreach letters to patient advocacy groups (documents named 'Advocacy outreach letter' are present for multiple countries, e.g., CZ, PT, NO, HU, FR, NL, SE, EL, IT, ES).
• Patient-facing materials: patient recruitment brochures, patient flyers, and patient trial cards for distribution at sites and to interested patients (country-specific materials present: Czechia, Norway, Portugal, Hungary, Sweden, Greece, France, Spain, Italy, Netherlands, Belgium, Ireland).
• GP / primary care physician communication letters to inform referring physicians (GP letters listed for some countries, e.g., PT, IT).
• Site-based 'Scout' program: email communications, ScoutPass (reloadable), Scout study brochure and Scout ICF/consent procedures to identify and engage potential participants (documents present in several countries e.g., NO, PT, NL, BE).
• Emergency/participant ID cards and visit guides provided to participants (documents listed as participant emergency card / visit guide).

Austria

Earliest CTIS Part Ii Submission Date

18-04-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

188

Number Of Sites

4

Number Of Participants

5

Czechia

Earliest CTIS Part Ii Submission Date

17-04-2024

Latest Decision Or Authorization Date

12-06-2024

Processing Time Days

56

Number Of Sites

2

Number Of Participants

2

Norway

Earliest CTIS Part Ii Submission Date

06-05-2024

Latest Decision Or Authorization Date

14-06-2024

Processing Time Days

39

Number Of Sites

2

Number Of Participants

2

Portugal

Earliest CTIS Part Ii Submission Date

09-05-2024

Latest Decision Or Authorization Date

12-06-2024

Processing Time Days

34

Number Of Sites

4

Number Of Participants

6

Sweden

Earliest CTIS Part Ii Submission Date

20-04-2024

Latest Decision Or Authorization Date

14-06-2024

Processing Time Days

55

Number Of Sites

3

Number Of Participants

1

Greece

Earliest CTIS Part Ii Submission Date

21-02-2024

Latest Decision Or Authorization Date

17-06-2024

Processing Time Days

117

Number Of Sites

3

Number Of Participants

4

Hungary

Earliest CTIS Part Ii Submission Date

20-03-2024

Latest Decision Or Authorization Date

13-06-2024

Processing Time Days

85

Number Of Sites

4

Number Of Participants

3

Netherlands

Earliest CTIS Part Ii Submission Date

23-04-2024

Latest Decision Or Authorization Date

17-06-2024

Processing Time Days

55

Number Of Sites

6

Number Of Participants

1

Ireland

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

14-06-2024

Processing Time Days

60

Number Of Sites

4

Number Of Participants

2

France

Earliest CTIS Part Ii Submission Date

24-04-2024

Latest Decision Or Authorization Date

12-06-2024

Processing Time Days

49

Number Of Sites

12

Number Of Participants

14

Spain

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

12-06-2024

Processing Time Days

71

Number Of Sites

23

Number Of Participants

42

Italy

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

14-06-2024

Processing Time Days

73

Number Of Sites

17

Number Of Participants

11

Belgium

Earliest CTIS Part Ii Submission Date

22-04-2024

Latest Decision Or Authorization Date

12-06-2024

Processing Time Days

51

Number Of Sites

5

Number Of Participants

5

Primary sponsor

Full Name

Seagen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Multiple sponsorDuties (codes: 1,12,15,5,8) including document collection for Part II in GR/HU/CZ (text provided in duties). Contact: Gilles.Galliot@iconplc.com

Name

PPD Development LP

Responsibilities

sponsorDuties code: 4 (as listed); contact: deborah.ferstl@ppd.com

Name

Bioclinica Inc.

Responsibilities

sponsorDuties code: 4 (as listed); contact: Jenna.Sturzik@Clario.com

Name

Frontage Laboratories Inc.

Responsibilities

sponsorDuties code: 4 (as listed); contact: BWalter@frontagelab.com

Name

Labcorp Central Laboratory Services LP

Responsibilities

sponsorDuties code: 4 (as listed); contact: andrea.ellingwood@labcorp.com

Name

Advarra Inc.

Responsibilities

sponsorDuties code: 2 (as listed); contact: eimear.odonnell@advarra.com

Name

WCG Clinical Inc.

Responsibilities

sponsorDuties code: 7 (as listed); contact: jwhittier@wcgclinical.com

Name

Cytel Inc.

Responsibilities

sponsorDuties code: 6 (as listed); contact: mary.young@cytel.com

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties code: 3 (as listed); contact: Rachel.JOHNSON@3ds.com

Name

4g Clinical LLC

Responsibilities

sponsorDuties code: 3 (as listed); contact: info@4gclinical.com

Third parties

• {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: [14]; contact: sophie.meyer@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact: jwhittier@wcgclinical.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact: Jenna.Sturzik@Clario.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact: BWalter@frontagelab.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"sponsorDuties codes: [2]; contact: eimear.odonnell@advarra.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,15,5,8]; note: For Greece, Hungary and Czech Republic: collection of documents for submission CTR Part II for initial submission; contact: Gilles.Galliot@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]; contact: andrea.ellingwood@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]; contact: info@4gclinical.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"sponsorDuties codes: [4]; contact: kristine.ciruelas@cellcarta.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]; contact: deborah.ferstl@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"sponsorDuties codes: [6]; contact: mary.young@cytel.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [3]; contact: Rachel.JOHNSON@3ds.com","organisation_type":"Non-Pharmaceutical company"}