Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer (KESTREL)

A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Biological: MEDI4736; Biological: Tremelimumab; Biological: MEDI4736+Tremelimumab; Biological: Cetuximab; Drug: 5-fluorouracil (5FU); Drug: Cisplatin; Drug: Carboplatin

Detailed Description

Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.

• Study Type: Interventional
• Enrollment (Actual): 823
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Linz, Austria, 4010
    • Research Site
  • Wien, Austria, 1140
    • Research Site
• Belgium
  • Brussels, Belgium, 1000
    • Research Site
  • Brussels, Belgium, 1090
    • Research Site
  • Bruxelles, Belgium, 1200
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Namur, Belgium, 5000
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Curitiba, Brazil, 81520-060
    • Research Site
  • Florianópolis, Brazil, 88034-000
    • Research Site
  • Ijui, Brazil, 98700-000
    • Research Site
  • Porto Alegre, Brazil, 90035-003
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Research Site
  • Porto Alegre, Brazil, 90619-900
    • Research Site
  • Recife, Brazil, 50040-000
    • Research Site
  • Rio de Janeiro, Brazil, 22793-080
    • Research Site
  • Santo Andre, Brazil, 09080-110
    • Research Site
  • Santo André, Brazil, 09060-650
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 03102-002
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Research Site
    • London, Ontario, Canada, N6A 4L6
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
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  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Research Site
• France
  • Bordeaux, France, 33000
    • Research Site
  • Brest, France, 29200
    • Research Site
  • Dijon, France, 21079
    • Research Site
  • Lyon Cedex 08, France, 69373
    • Research Site
  • Nice, France, 06100
    • Research Site
  • Paris, France, 75015
    • Research Site
  • Poitiers Cedex, France, 86021
    • Research Site
  • Toulouse Cedex, France, 31059
    • Research Site
  • Vandoeuvre les Nancy, France, 54519
    • Research Site
  • Villejuif, France, 94800
    • Research Site
• Germany
  • Berlin, Germany, 12203
    • Research Site
  • Erlangen, Germany, 91054
    • Research Site
  • Essen, Germany, 45147
    • Research Site
  • Frankfurt am Main, Germany, 60590
    • Research Site
  • Freiburg, Germany, 79106
    • Research Site
  • Hamburg, Germany, 20246
    • Research Site
  • Heidelberg, Germany, 69120
    • Research Site
  • Mainz, Germany, 55131
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  • Tübingen, Germany, 72076
    • Research Site
  • Würzburg, Germany, 97070
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 18547
    • Research Site
  • Athens, Greece, 115 22
    • Research Site
  • Athens, Greece, 124 61
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  • Heraklion, Greece, 711 11
    • Research Site
  • Thessaloniki, Greece, 54645
    • Research Site
• India
  • Bangalore, India, 560076
    • Research Site
  • Bangalore, India, 560027
    • Research Site
  • Bengaluru, India, 560076
    • Research Site
  • Gurgaon, India, 122001
    • Research Site
  • Karamsad, India, 388325
    • Research Site
  • Madurai, India, 625107
    • Research Site
  • Pune, India, 411001
    • Research Site
• Italy
  • Cona, Italy, 44124
    • Research Site
  • Firenze, Italy, 50134
    • Research Site
  • Messina, Italy, 98158
    • Research Site
  • Milano, Italy, 20133
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Palermo, Italy, 90127
    • Research Site
  • Salerno, Italy, 84131
    • Research Site
  • Siena, Italy, 53100
    • Research Site
  • Torino, Italy, 10126
    • Research Site
• Japan
  • Akashi-shi, Japan, 673-8558
    • Research Site
  • Chiba-shi, Japan, 260-8717
    • Research Site
  • Fukuoka-shi, Japan, 811-1347
    • Research Site
  • Hirakata-shi, Japan, 573-1191
    • Research Site
  • Isehara-shi, Japan, 259-1193
    • Research Site
  • Kagoshima-shi, Japan, 890-8520
    • Research Site
  • Kanazawa-shi, Japan, 920-8650
    • Research Site
  • Kitaadachi-gun, Japan, 362-0806
    • Research Site
  • Kobe-shi, Japan, 650-0017
    • Research Site
  • Koto-ku, Japan, 135-8550
    • Research Site
  • Natori-shi, Japan, 981-1293
    • Research Site
  • Okayama-shi, Japan, 700-8558
    • Research Site
  • Osaka-shi, Japan, 541-8567
    • Research Site
  • Osakasayama, Japan, 589-8511
    • Research Site
  • Sapporo, Japan, 060-8648
    • Research Site
  • Sapporo-shi, Japan, 003-0804
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
  • Takatsuki-shi, Japan, 569-8686
    • Research Site
  • Toyoake-shi, Japan, 470-1192
    • Research Site
  • Yokohama-shi, Japan, 241-8515
    • Research Site
• Korea, Republic of
  • Cheongju-si, Korea, Republic of, 28644
    • Research Site
  • Hwasun-gun, Korea, Republic of, 58128
    • Research Site
  • Incheon, Korea, Republic of, 21565
    • Research Site
  • Seo-Gu, Korea, Republic of, 49241
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 135-710
    • Research Site
  • Suwon-si, Korea, Republic of, 16499
    • Research Site
• Philippines
  • Cebu City, Philippines, 6000
    • Research Site
  • Las Pinas, Philippines, 1740
    • Research Site
  • Quezon City, Philippines, 1112
    • Research Site
• Poland
  • Białystok, Poland, 15-027
    • Research Site
  • Bielsko-Biała, Poland, 43-300
    • Research Site
  • Gdańsk, Poland, 80-214
    • Research Site
  • Gdynia, Poland, 81-519
    • Research Site
  • Lublin, Poland, 20-090
    • Research Site
  • Poznan, Poland, 61-866
    • Research Site
  • Poznan, Poland, 60-780
    • Research Site
  • Szczecin, Poland, 71-730
    • Research Site
  • Warszawa, Poland, 02-781
    • Research Site
  • Łódź, Poland, 93-513
    • Research Site
• Romania
  • Suceava, Romania, 720237
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Research Site
  • Ekaterinburg, Russian Federation, 620905
    • Research Site
  • Krasnodar, Russian Federation, 350040
    • Research Site
  • Moscow, Russian Federation, 125367
    • Research Site
  • Obninsk, Russian Federation, 249036
    • Research Site
  • Omsk, Russian Federation, 644013
    • Research Site
  • Saint Petersburg, Russian Federation, 195271
    • Research Site
  • Saint Petersburg, Russian Federation, 198255
    • Research Site
  • Saint-Petersburg, Russian Federation, 197758
    • Research Site
  • Sochi, Russian Federation, 354057
    • Research Site
  • St.Petersburg, Russian Federation, 191014
    • Research Site
  • Ufa, Russian Federation, 450054
    • Research Site
• Slovakia
  • Bratislava, Slovakia, 833 01
    • Research Site
  • Kosice, Slovakia, 041 91
    • Research Site
• Spain
  • Badajoz, Spain, 06008
    • Research Site
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Jaén, Spain, 23007
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08907
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28050
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Marbella, Spain, 29600
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan, 10449
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Pathumthani, Thailand, 12120
    • Research Site
• Ukraine
  • Dnipro, Ukraine, 49102
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Kapitanivka Village, Ukraine, 08111
    • Research Site
  • Kharkiv Region, Ukraine, 61070
    • Research Site
  • Kirovohrad, Ukraine, 25006
    • Research Site
  • Kryvyi Rih, Ukraine, 50048
    • Research Site
  • Kyiv, Ukraine, 03115
    • Research Site
  • Kyiv, Ukraine, 03022
    • Research Site
  • Odesa, Ukraine, 65055
    • Research Site
  • Sumy, Ukraine, 40022
    • Research Site
  • Vinnytsia, Ukraine, 21029
    • Research Site
• United Kingdom
  • Bebington, United Kingdom, CH63 4JY
    • Research Site
  • Birmingham, United Kingdom, B15 2TT
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Research Site
  • London, United Kingdom, SW3 6JJ
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Research Site
  • Taunton, United Kingdom, TA1 5DA
    • Research Site
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Research Site
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Research Site
    • Saint Petersburg, Florida, United States, 33705
      • Research Site
    • Tampa, Florida, United States, 33612
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Research Site
    • Baltimore, Maryland, United States, 21231
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Research Site
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Research Site
  • New York
    • New York, New York, United States, 10065
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Research Site
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Winston-Salem, North Carolina, United States, 27157
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Research Site
    • Columbus, Ohio, United States, 43210
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Research Site
• Vietnam
  • Ha Noi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam
    • Research Site
  • Ho Chi Minh city, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years at the time of screening
2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
4. No prior systemic chemotherapy for recurrent or metastatic disease
5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. No prior exposure to immune-mediated therapy,

Exclusion Criteria:

1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Standard of Care treatment	Biological: Cetuximab; Monoclonal Antibody; Drug: 5-fluorouracil (5FU); Chemotherapy Agent; Drug: Cisplatin; Chemotherapy agent; Drug: Carboplatin; Chemotherapy Agent
Experimental: Monotherapy; MEDI4736 monotherapy.	Biological: MEDI4736; Anti-PD-L1 antibody
Experimental: Combination Therapy; MEDI4736+Tremelimumab combination therapy	Biological: Tremelimumab; Anti-CTLA-4 Antibody; Biological: MEDI4736+Tremelimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)	Number of participants with Overall Survival (OS)	From date of randomization until time of final analysis, an average of approximately 4 years
Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup	Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)	From date of randomization until time of final analysis, an average of approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)	Number of participants with Overall Survival (OS)	From date of randomization until time of final analysis, an average of approximately 4 years
Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup	Percentage of patients alive	12, 18 and 24 months after randomization
Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup	Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup	Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup	Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Overall Survival (OS) Status in the All-comers (Full Analysis Set)	Number of participants with Overall Survival (OS)	From date of randomization until time of final analysis, an average of approximately 4 years
Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)	Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)	From date of randomization until time of final analysis, an average of approximately 4 years
Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)	Percentage of patients alive	12, 18 and 24 months after randomization
Progression Free Survival (PFS) in the All-comers (Full Analysis Set)	Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Objective Response Rate (ORR) in the All-comers (Full Analysis Set)	Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Duration of Response (DoR) in the All-comers (Full Analysis Set)	Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Richard Olsson; Principal Investigator: Tanguy Seiwert, The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637

Publications and helpful links

General Publications

• Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available. Erratum In: Lancet Oncol. 2021 Apr;22(4):e134.

Helpful Links

• Related Info
• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Carboplatin; Cisplatin; Fluorouracil; Durvalumab; Tremelimumab; Antibodies, Monoclonal; Cetuximab
• Other Study ID Numbers: D419LC00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan 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 Sharing 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 Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No