Study of Cemiplimab in Adults With Cervical Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

608

Participants

Timeline

Start Date

September 5, 2017

Primary Completion Date

March 15, 2021

Study Completion Date

April 20, 2023

Conditions
Squamous Cell Carcinoma (SCC)Recurrent or Metastatic, Platinum-refractory Cervical Cancer
Interventions
DRUG

Cemiplimab

Intravenous (IV) administration every 3 weeks (Q3W)

DRUG

Investigator Choice (IC) Chemotherapy

"IC chemotherapy options include:~1. Antifolate: Pemetrexed~2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan~3. Nucleoside analogue: Gemcitabine~4. 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."

Trial Locations (105)

112

Koo-Foundation Sun Yat-Sen Cancer Center, Taipei

Taipei Veterans General Hospital, Taipei

1000

Institut Bordet, Brussels

1200

Cliniques universitaires Saint-Luc, Brussels

2217

St. George Hospital, Kogarah

2485

Northern NSW Health District, The Tweed Hospital, Tweed Heads

3000

UZLeuven Gynaelologic Oncology, Leuven

4000

CHC Saint Joseph, Liège

CHU Liège, Liège

4011

Royal Brisbane & Women's Hospital, Herston

5000

CHU UCL Namur site Sainte Elisabeth, Namur

6008

St. John of God Subiaco Hospital, Subiaco

6009

Sir Charles Gairdner Hospital, Nedlands

9300

OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie, Aalst

10016

Laura and Issac Perlmutter Cancer Center at NYU Langone, New York

10408

National Cancer Center, Goyang-si

10449

MacKay Memorial Hospital, Taipei

11042

Northwell Health, Lake Success

11355

New York Presbyterian Queens, Flushing

11528

General Hospital of Athens Alexandra, Athens

14004

Hospital Reina Sofia, Córdoba

17007

Instituto Catalan de Oncologia de Gerona, Girona

19107

Thomas Jefferson University Hospital, Philadelphia

20141

Istituto Europeo di Oncologia, Milan

23900

Asst Lecco, Lecco

26335

General Hospital of Patras, Pátrai

28034

Hospital Ramon y Cajal, Madrid

28050

Hospital Universitario HM Sanchinarro CIOCC, Madrid

28374

First Health of the Carolinas Outpatient Cancer Center, Pinehurst

29010

Hospital Virgen de la Victoria, Málaga

40138

Azienda Ospedaliero Universitaria di Bologna, Bologna

40705

Taichung Veterans General Hospital, Taichung

41931

Keimyung University Dongsan Medical Center, Daegu

42122

AUSL, IRCCS di Reggio Emilia, Reggio Emilia

45110

University Hospital of Ioannina, Ioannina

46009

Fundacion Instituto Valenciano de Oncologia, Valencia

46026

Hospital Universitario La Fe, Valencia

47014

Irst Irccs, Meldola

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

54645

Euromedica General Clinic, B'Oncology Clinic, Thessaloniki

65804

Cancer Research for the Ozarks, Springfield

70121

Ochsner Clinic Foundation, New Orleans

73100

U.O Oncologia Medica P.O Vito Fazzi, Lecce

78745

Texas Oncology, P.A., Austin

85016

Arizona Oncology Associates, Phoenix

85711

Arizona Oncology Associates, Tucson

92868

University of California Irvine, Orange

153040

Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary, Ivanovo

188663

"State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI LROD)", Vsevolozhsk

197022

"Saint- Petersburg State Budgetary institution of Healthcare City Clinical Oncological Dispensary", Saint Petersburg

249036

A. Tsyb Medical Radiological Research Center, Obninsk

350040

State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region, Krasnodar

360000

"State Budgetary Healthcare Institution Oncology Dispensary of Ministry of Healthcare of the Kabardino-Balkarian Republic", Nal'chik

420029

State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic, Kazan'

460021

"State Budgetary Institution of Healthcare Orenburg Regional Clinical Oncology Dispensary", Orenburg

644013

Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary, Omsk

03000

Peter MacCallum Cancer Centre, Melbourne

59075-740

Liga Norte Riograndense Contra o Câncer, Natal

09619-900

Hosptial Sao Lucas da PUC de Porto Alegre, Porto Alegre

90035-072

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

88301-220

Centro de Novos Tratamentos Itajai, Itajaí

14784-400

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos

95070-560

Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM, Caxias do Sul

20220-410

Instituto Nacional de Cancer - INCA, Rio de Janeiro

22793-080

Instituto COI de Pesquisa, Rio de Janeiro

T2N4N2

Tom Baker Cancer Center, Calgary

V5Z 4E6

British Columbia Cancer Agency, Vancouver

N6A 4L6

London Health Sciences Centre, London

M5G 1Z5

Princess Margaret Cancer Centre, Toronto

H1T 2M4

Hospital Maisonneuve-Rosemont, Montreal

H2L 4M1

Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal, Montreal

H3T 1E2

Jewish General Hospital, Montreal

00168

Fondazione Policlinico Agostino Gemelli IRCCS di Roma, Roma

00144

Regina Elena National Cancer Institute, Rome

791-0281

Shikoku Cancer Center, Matsuyama

791-0296

Ehime University Hospital, Tōon

910-1194

Fukui University Hospital, Yoshida-gun

830-0012

Kurume University Hospital, Kurume

060-8649

Hokkaido University Hospital, Sapporo

216-8512

St. Marianna University School of Medicine Hospital, Kawasaki

903-0216

University of the Ryukyus Hospital, Nakagami-gun

350-0495

Saitama Medical University, Saitama

104-0046

National Cancer Center Hospital, Chuo-ku

135-8551

The Cancer Institute Hospital of JFCR, Koto-Ku

181-8612

Kyorin University Hospital, Mitaka

362-0806

Saitama Cancer Center, Saitama

811-1395

National Kyushu Cancer Center, Fukuoka

890-8761

Kagoshima City Hospital, Kagoshima

15-027

Bialostockie Centrum Onkologii, Bialystok

81-519

Szpitale Pomorskie, Gdynia

44-101

Center and Institute of Oncology Gliwice, Gliwice

20-090

Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli, Lublin

61-866

Greater Poland Cancer Center, Poznan

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

07120

Hospital Universitario Son Espases, Palma de Mallorca

08035

Vall d´Hebron University Hospital, Barcelona

CF14 2TL

Velindre Cancer Centre, Cardiff

G12 0YN

NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care, Glasgow

NW1 2BU

University College Hospital, London

SW3 6JJ

Royal Marsden NHS Foundation Trust, Chelsea, London

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton, Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Regeneron Pharmaceuticals

INDUSTRY