Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
608 participants
INTERVENTIONAL
2017-09-05
2023-04-20
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Therapy
Cemiplimab
Cemiplimab
Intravenous (IV) administration every 3 weeks (Q3W)
Control Therapy
Investigator choice (IC) chemotherapy
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.
Interventions
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Cemiplimab
Intravenous (IV) administration every 3 weeks (Q3W)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Arizona Oncology Associates
Phoenix, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
University of California Irvine
Orange, California, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
New York Presbyterian Queens
Flushing, New York, United States
Northwell Health
Lake Success, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
First Health of the Carolinas Outpatient Cancer Center
Pinehurst, North Carolina, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Texas Oncology, P.A.
Austin, Texas, United States
St. George Hospital
Kogarah, New South Wales, Australia
Northern NSW Health District, The Tweed Hospital
Tweed Heads, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia
OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie
Aalst, , Belgium
Institut Bordet
Brussels, , Belgium
Cliniques universitaires Saint-Luc
Brussels, , Belgium
UZLeuven Gynaelologic Oncology
Leuven, , Belgium
CHC Saint Joseph
Liège, , Belgium
CHU Liège
Liège, , Belgium
CHU UCL Namur site Sainte Elisabeth
Namur, , Belgium
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hosptial Sao Lucas da PUC de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Novos Tratamentos Itajai
Itajaí, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM
Caxias do Sul, , Brazil
Instituto Nacional de Cancer - INCA
Rio de Janeiro, , Brazil
Instituto COI de Pesquisa
Rio de Janeiro, , Brazil
Tom Baker Cancer Center
Calgary, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
General Hospital of Athens Alexandra
Athens, , Greece
University Hospital of Ioannina
Ioannina, , Greece
General Hospital of Patras
Pátrai, , Greece
Euromedica General Clinic, B'Oncology Clinic
Thessaloniki, , Greece
Azienda Ospedaliero Universitaria di Bologna
Bologna, , Italy
U.O Oncologia Medica P.O Vito Fazzi
Lecce, , Italy
Asst Lecco
Lecco, , Italy
Irst Irccs
Meldola, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
AUSL, IRCCS di Reggio Emilia
Reggio Emilia, , Italy
Fondazione Policlinico Agostino Gemelli IRCCS di Roma
Roma, , Italy
Regina Elena National Cancer Institute
Rome, , Italy
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Ehime University Hospital
Tōon, Ehime, Japan
Fukui University Hospital
Yoshida-gun, Fukui, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
University of the Ryukyus Hospital
Nakagami-gun, Okinawa, Japan
Saitama Medical University
Saitama, Saitama, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Saitama Cancer Center
Saitama, Tokyo, Japan
National Kyushu Cancer Center
Fukuoka, , Japan
Kagoshima City Hospital
Kagoshima, , Japan
Bialostockie Centrum Onkologii
Bialystok, , Poland
Szpitale Pomorskie
Gdynia, , Poland
Center and Institute of Oncology Gliwice
Gliwice, , Poland
Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli
Lublin, , Poland
Greater Poland Cancer Center
Poznan, , Poland
Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary
Ivanovo, Ivanovo Oblast, Russia
State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic
Nal'chik, Kabardino-Balkarian, Russia
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, Russia
State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region
Krasnodar, Krasnodar Territory, Russia
State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI "LROD")
Vsevolozhsk, Leningradskaya Oblast', Russia
State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic
Kazan', Tatarstan Republic, Russia
Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary
Omsk, , Russia
State Budgetary Institution of Healthcare "Orenburg Regional Clinical Oncology Dispensary"
Orenburg, , Russia
Saint- Petersburg State Budgetary institution of Healthcare "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Vall d´Hebron University Hospital
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Instituto Catalan de Oncologia de Gerona
Girona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario HM Sanchinarro CIOCC
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
MacKay Memorial Hospital
Taipei, , Taiwan
Koo-Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Velindre Cancer Centre
Cardiff, , United Kingdom
NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care
Glasgow, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Marsden NHS Foundation Trust, Chelsea
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton
Sutton, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Summary is available on TrialSummaries.com
Other Identifiers
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2017-000350-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R2810-ONC-1676
Identifier Type: -
Identifier Source: org_study_id
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