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Study of Cemiplimab in Adults With Cervical Cancer

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cemiplimab
Investigator Choice (IC) Chemotherapy
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma (SCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology Associates
  • Arizona Oncology Associates
  • University of California Irvine
  • Ochsner Clinic Foundation
  • Cancer Research for the Ozarks
  • New York Presbyterian Queens
  • Northwell Health
  • Laura and Issac Perlmutter Cancer Center at NYU Langone
  • First Health of the Carolinas Outpatient Cancer Center
  • Thomas Jefferson University Hospital
  • Texas Oncology, P.A.
  • St. George Hospital
  • Northern NSW Health District, The Tweed Hospital
  • Royal Brisbane & Women's Hospital
  • Peter MacCallum Cancer Centre
  • Sir Charles Gairdner Hospital
  • St. John of God Subiaco Hospital
  • OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie
  • Institut Bordet
  • Cliniques universitaires Saint-Luc
  • UZLeuven Gynaelologic Oncology
  • CHC Saint Joseph
  • CHU Liège
  • CHU UCL Namur site Sainte Elisabeth
  • Liga Norte Riograndense Contra o Câncer
  • Hosptial Sao Lucas da PUC de Porto Alegre
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Centro de Novos Tratamentos Itajai
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM
  • Instituto Nacional de Cancer - INCA
  • Instituto COI de Pesquisa
  • Tom Baker Cancer Center
  • British Columbia Cancer Agency
  • London Health Sciences Centre
  • Princess Margaret Cancer Centre
  • Hospital Maisonneuve-Rosemont
  • Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
  • Jewish General Hospital
  • General Hospital of Athens Alexandra
  • University Hospital of Ioannina
  • General Hospital of Patras
  • Euromedica General Clinic, B'Oncology Clinic
  • Azienda Ospedaliero Universitaria di Bologna
  • U.O Oncologia Medica P.O Vito Fazzi
  • Asst Lecco
  • Irst Irccs
  • Istituto Europeo di Oncologia
  • AUSL, IRCCS di Reggio Emilia
  • Fondazione Policlinico Agostino Gemelli IRCCS di Roma
  • Regina Elena National Cancer Institute
  • Shikoku Cancer Center
  • Ehime University Hospital
  • Fukui University Hospital
  • Kurume University Hospital
  • Hokkaido University Hospital
  • St. Marianna University School of Medicine Hospital
  • University of the Ryukyus Hospital
  • Saitama Medical University
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Kyorin University Hospital
  • Saitama Cancer Center
  • National Kyushu Cancer Center
  • Kagoshima City Hospital
  • National Cancer Center
  • Keimyung University Dongsan Medical Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Korea University Guro Hospital
  • Bialostockie Centrum Onkologii
  • Szpitale Pomorskie
  • Center and Institute of Oncology Gliwice
  • Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli
  • Greater Poland Cancer Center
  • Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary
  • State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic
  • A. Tsyb Medical Radiological Research Center
  • State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region
  • State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI "LROD")
  • State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic
  • Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary
  • State Budgetary Institution of Healthcare "Orenburg Regional Clinical Oncology Dispensary"
  • Saint- Petersburg State Budgetary institution of Healthcare "City Clinical Oncological Dispensary"
  • Hospital Universitario Son Espases
  • Vall d´Hebron University Hospital
  • Hospital Reina Sofia
  • Instituto Catalan de Oncologia de Gerona
  • Hospital Ramon y Cajal
  • Hospital Universitario HM Sanchinarro CIOCC
  • Hospital Virgen de la Victoria
  • Fundacion Instituto Valenciano de Oncologia
  • Hospital Universitario La Fe
  • Hospital Clinico Universitario Lozano Blesa
  • Taichung Veterans General Hospital
  • MacKay Memorial Hospital
  • Koo-Foundation Sun Yat-Sen Cancer Center
  • Taipei Veterans General Hospital
  • Velindre Cancer Centre
  • NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care
  • University College Hospital
  • Royal Marsden NHS Foundation Trust, Chelsea
  • Nottingham University Hospitals NHS Trust
  • Royal Marsden NHS Foundation Trust, Sutton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Therapy

Control Therapy

Arm Description

Cemiplimab

Investigator choice (IC) chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 26, 2017
Last Updated
July 7, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03257267
Brief Title
Study of Cemiplimab in Adults With Cervical Cancer
Official Title
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
608 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Therapy
Arm Type
Experimental
Arm Description
Cemiplimab
Arm Title
Control Therapy
Arm Type
Active Comparator
Arm Description
Investigator choice (IC) chemotherapy
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Intravenous (IV) administration every 3 weeks (Q3W)
Intervention Type
Drug
Intervention Name(s)
Investigator Choice (IC) Chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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 Frame
Time from randomization to the date of death due to any cause (assessed up to 40 months)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Description
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 Frame
Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
Title
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
Description
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.
Time Frame
From date of randomization up to 40 months
Title
Duration of Response (DOR) Assessed Per RECIST 1.1
Description
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 Frame
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)
Title
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
Description
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.
Time Frame
From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
Description
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.
Time Frame
From date of randomization up to 40 months
Title
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
Description
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.
Time Frame
From date of randomization up to 40 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer) Patient must have measurable disease as defined by RECIST 1.1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 ≥18 years old Adequate organ or bone marrow function Received prior bevacizumab therapy or had clinically documented reason why not administered Received prior paclitaxel therapy or had clinically documented reason why not administered Key Exclusion Criteria: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments Prior treatment with an agent that blocks the PD-1/PD-L1 pathway Prior treatment with other systemic immune-modulating agents that was within fewer than 4 weeks (28 days) of the enrollment date, or associated with irAEs of any grade within 90 days prior to enrollment, or associated with toxicity that resulted in discontinuation of the immune modulating agent Active or untreated brain metastases Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo) Active infection requiring therapy History of pneumonitis within the last 5 years History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
New York Presbyterian Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Laura and Issac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
First Health of the Carolinas Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Texas Oncology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Northern NSW Health District, The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4011
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
03000
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
St. John of God Subiaco Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Institut Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZLeuven Gynaelologic Oncology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHC Saint Joseph
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur site Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Liga Norte Riograndense Contra o Câncer
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hosptial Sao Lucas da PUC de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
09619-900
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-072
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM
City
Caxias do Sul
ZIP/Postal Code
95070-560
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCA
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Instituto COI de Pesquisa
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Hospital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
General Hospital of Athens Alexandra
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45110
Country
Greece
Facility Name
General Hospital of Patras
City
Patras
ZIP/Postal Code
26335
Country
Greece
Facility Name
Euromedica General Clinic, B'Oncology Clinic
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Azienda Ospedaliero Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
U.O Oncologia Medica P.O Vito Fazzi
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Asst Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Irst Irccs
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
AUSL, IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42122
Country
Italy
Facility Name
Fondazione Policlinico Agostino Gemelli IRCCS di Roma
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Regina Elena National Cancer Institute
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0281
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0296
Country
Japan
Facility Name
Fukui University Hospital
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1194
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0012
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8649
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8512
Country
Japan
Facility Name
University of the Ryukyus Hospital
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0216
Country
Japan
Facility Name
Saitama Medical University
City
Saitama
State/Province
Saitama Prefecture
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0046
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
135-8551
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8612
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
State/Province
Tokyo
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kagoshima City Hospital
City
Kagoshima
ZIP/Postal Code
890-8761
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Bialostockie Centrum Onkologii
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Szpitale Pomorskie
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Center and Institute of Oncology Gliwice
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Greater Poland Cancer Center
City
Poznań
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary
City
Ivanovo
State/Province
Ivanovo Region
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic
City
Nal'chik
State/Province
Kabardino-Balkarian
ZIP/Postal Code
360000
Country
Russian Federation
Facility Name
A. Tsyb Medical Radiological Research Center
City
Obninsk
State/Province
Kaluga
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region
City
Krasnodar
State/Province
Krasnodar Territory
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI "LROD")
City
Vsevolozhsk
State/Province
Leningrad Region
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare "Orenburg Regional Clinical Oncology Dispensary"
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Saint- Petersburg State Budgetary institution of Healthcare "City Clinical Oncological Dispensary"
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Facility Name
Vall d´Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Instituto Catalan de Oncologia de Gerona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Koo-Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust, Chelsea
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust, Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Citations:
PubMed Identifier
35922251
Citation
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.
Results Reference
derived
PubMed Identifier
35139273
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Cemiplimab in Adults With Cervical Cancer

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