Study of Cemiplimab in Adults With Cervical Cancer

An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy.

The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are:

• To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy
• To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy
• To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE)
• To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma (SCC); Recurrent or Metastatic, Platinum-refractory Cervical Cancer
• Intervention / Treatment: Drug: Cemiplimab; Drug: Investigator Choice (IC) Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St. George Hospital
    • Tweed Heads, New South Wales, Australia, 2485
      • Northern NSW Health District, The Tweed Hospital
  • Queensland
    • Herston, Queensland, Australia, 4011
      • Royal Brisbane & Women's Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 03000
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
    • Subiaco, Western Australia, Australia, 6008
      • St. John of God Subiaco Hospital
• Belgium
  • Aalst, Belgium, 9300
    • OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie
  • Brussels, Belgium, 1000
    • Institut Bordet
  • Bruxelles, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • UZLeuven Gynaelologic Oncology
  • Liège, Belgium, 4000
    • Chu Liege
  • Liège, Belgium, 4000
    • CHC Saint Joseph
  • Namur, Belgium, 5000
    • CHU UCL Namur Site Sainte Elisabeth
• Brazil
  • Caxias do Sul, Brazil, 95070-560
    • Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM
  • Rio de Janeiro, Brazil, 20220-410
    • Instituto Nacional de Câncer - INCA
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto COI de Pesquisa
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Liga Norte Riograndense Contra o Câncer
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 09619-900
      • Hosptial Sao Lucas da PUC de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-072
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Centro De Novos Tratamentos Itajai
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N2
      • Tom Baker Cancer Center
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hospital Maisonneuve-Rosemont
    • Montréal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montréal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
• Greece
  • Athens, Greece, 11528
    • General Hospital of Athens Alexandra
  • Ioannina, Greece, 45110
    • University Hospital of Ioannina
  • Patras, Greece, 26335
    • General Hospital of Patras
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic, B'Oncology Clinic
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria di Bologna
  • Lecce, Italy, 73100
    • U.O Oncologia Medica P.O Vito Fazzi
  • Lecco, Italy, 23900
    • ASST Lecco
  • Meldola, Italy, 47014
    • Irst Irccs
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia
  • Reggio Emilia, Italy, 42122
    • AUSL, IRCCS di Reggio Emilia
  • Roma, Italy, 00168
    • Fondazione Policlinico Agostino Gemelli IRCCS di Roma
  • Rome, Italy, 00144
    • Regina Elena National Cancer Institute
• Japan
  • Fukuoka, Japan, 811-1395
    • National Kyushu Cancer Center
  • Kagoshima, Japan, 890-8761
    • Kagoshima City Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0281
      • Shikoku Cancer Center
    • Toon, Ehime, Japan, 791-0296
      • Ehime University Hospital
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1194
      • Fukui University Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0012
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8649
      • Hokkaido University Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8512
      • St. Marianna University School of Medicine Hospital
  • Okinawa
    • Nakagami-gun, Okinawa, Japan, 903-0216
      • University of the Ryukyus Hospital
  • Saitama Prefecture
    • Saitama, Saitama Prefecture, Japan, 350-0495
      • Saitama Medical University
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0046
      • National Cancer Center Hospital
    • Koto-Ku, Tokyo, Japan, 135-8551
      • The Cancer Institute Hospital Of JFCR
    • Mitaka, Tokyo, Japan, 181-8612
      • Kyorin University Hospital
    • Saitama, Tokyo, Japan, 362-0806
      • Saitama Cancer Center
• Korea, Republic of
  • Daegu, Korea, Republic of, 41931
    • Keimyung University Dongsan Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
• Poland
  • Białystok, Poland, 15-027
    • Bialostockie Centrum Onkologii
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie
  • Gliwice, Poland, 44-101
    • Center and Institute of Oncology Gliwice
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli
  • Poznań, Poland, 61-866
    • Greater Poland Cancer Center
• Russian Federation
  • Omsk, Russian Federation, 644013
    • Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary
  • Orenburg, Russian Federation, 460021
    • State Budgetary Institution of Healthcare "Orenburg Regional Clinical Oncology Dispensary"
  • Saint Petersburg, Russian Federation, 197022
    • Saint- Petersburg State Budgetary institution of Healthcare "City Clinical Oncological Dispensary"
  • Ivanovo Region
    • Ivanovo, Ivanovo Region, Russian Federation, 153040
      • Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary
  • Kabardino-Balkarian
    • Nal'chik, Kabardino-Balkarian, Russian Federation, 360000
      • State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic
  • Kaluga
    • Obninsk, Kaluga, Russian Federation, 249036
      • A. Tsyb Medical Radiological Research Center
  • Krasnodar Territory
    • Krasnodar, Krasnodar Territory, Russian Federation, 350040
      • State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region
  • Leningrad Region
    • Vsevolozhsk, Leningrad Region, Russian Federation, 188663
      • State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI "LROD")
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420029
      • State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic
• Spain
  • Barcelona, Spain, 08035
    • Vall d´Hebrón University Hospital
  • Cordoba, Spain, 14004
    • Hospital Reina Sofia
  • Girona, Spain, 17007
    • Instituto Catalan de Oncologia de Gerona
  • Madrid, Spain, 28034
    • Hospital Ramon Y Cajal
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro CIOCC
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Valencia, Spain, 46009
    • Fundación Instituto Valenciano de Oncología
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07120
      • Hospital Universitario Son Espases
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Koo-Foundation Sun Yat-Sen Cancer Center
  • Taipei City, Taiwan, 10449
    • Mackay Memorial Hospital
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • Glasgow, United Kingdom, G12 0YN
    • NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care
  • London, United Kingdom, NW1 2BU
    • University College Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden NHS Foundation Trust, Chelsea
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden NHS Foundation Trust, Sutton
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates
  • California
    • Orange, California, United States, 92868
      • University of California Irvine
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Cancer Research for the Ozarks
  • New York
    • Flushing, New York, United States, 11355
      • New York Presbyterian Queens
    • Lake Success, New York, United States, 11042
      • Northwell Health
    • New York, New York, United States, 10016
      • Laura and Issac Perlmutter Cancer Center at NYU Langone
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • First Health of the Carolinas Outpatient Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

The criteria listed below are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

Key Inclusion Criteria:

1. Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy).

   • Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) as defined in the protocol
2. Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer)
3. Patient must have measurable disease as defined by RECIST 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
5. ≥18 years old
6. Adequate organ or bone marrow function
7. Received prior bevacizumab therapy or had clinically documented reason why not administered
8. Received prior paclitaxel therapy or had clinically documented reason why not administered

Key Exclusion Criteria:

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway

3. Prior treatment with other systemic immune-modulating agents that was

   1. within fewer than 4 weeks (28 days) of the enrollment date, or
   2. associated with irAEs of any grade within 90 days prior to enrollment, or
   3. associated with toxicity that resulted in discontinuation of the immune modulating agent
4. Active or untreated brain metastases
5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo)
6. Active infection requiring therapy
7. History of pneumonitis within the last 5 years
8. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
9. Concurrent malignancy other than cervical cancer and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or death, such as adequately treated cutaneous squamous cell carcinoma or basal cell carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.

Note: Other protocol defined Inclusion/Exclusion apply

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Therapy; Cemiplimab	Drug: Cemiplimab; Intravenous (IV) administration every 3 weeks (Q3W); Other Names: REGN2810; Libtayo
Active Comparator: Control Therapy; Investigator choice (IC) chemotherapy	Drug: Investigator Choice (IC) Chemotherapy; IC chemotherapy options include: Antifolate: Pemetrexed; Topoisomerase 1 inhibitor: Topotecan or Irinotecan; Nucleoside analogue: Gemcitabine; Vinca alkaloid: Vinorelbine The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.	Time from randomization to the date of death due to any cause (assessed up to 40 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who do not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.	Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1	ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm) (<1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	From date of randomization up to 40 months
Duration of Response (DOR) Assessed Per RECIST 1.1	DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progress while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.	Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales	EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.	From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death	An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.	From date of randomization up to 40 months
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade	Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.	From date of randomization up to 40 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Oaknin A, Monk BJ, Vergote I, Cristina de Melo A, Kim YM, Lisyanskaya AS, Samouelian V, Kim HS, Gotovkin EA, Damian F, Chang CL, Takahashi S, Li J, Mathias M, Fury MG, Ivanescu C, Reaney M, LaFontaine PR, Lowy I, Harnett J, Chen CI, Tewari KS. EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer. Eur J Cancer. 2022 Oct;174:299-309. doi: 10.1016/j.ejca.2022.03.016. Epub 2022 Jul 31.
• Tewari KS, Monk BJ, Vergote I, Miller A, de Melo AC, Kim HS, Kim YM, Lisyanskaya A, Samouelian V, Lorusso D, Damian F, Chang CL, Gotovkin EA, Takahashi S, Ramone D, Pikiel J, Mackowiak-Matejczyk B, Guerra Alia EM, Colombo N, Makarova Y, Rischin D, Lheureux S, Hasegawa K, Fujiwara K, Li J, Jamil S, Jankovic V, Chen CI, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Mathias M, Fury MG, Oaknin A; Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med. 2022 Feb 10;386(6):544-555. doi: 10.1056/NEJMoa2112187.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1676; 2017-000350-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy
• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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