Study of Cemiplimab in Adults With Cervical Cancer

NCT03257267 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: R2810-ONC-16762017-000350-19
• Study Type: interventional
• Target: 608
• Locations: 14 countries
• Sites: 105

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)

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  From first dose up to 90 following last dose (~42 months)

• Overall Survival (OS) in the SCC Population

  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.

  From first dose up to 90 following last dose (~42 months)

Secondary Outcomes (6)

• Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  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

  From date of randomization up to 40 months

• Duration of Response (DOR) Assessed Per RECIST 1.1

  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

  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

  From first dose up to 90 following last dose (~36 months)

Study Arms (2)

Experimental Therapy

EXPERIMENTAL

Cemiplimab

Drug: Cemiplimab

Control Therapy

ACTIVE COMPARATOR

Investigator choice (IC) chemotherapy

Drug: Investigator Choice (IC) Chemotherapy

Interventions

Cemiplimab DRUG

Intravenous (IV) administration every 3 weeks (Q3W)

Also known as: REGN2810, Libtayo

Experimental Therapy

Investigator Choice (IC) Chemotherapy DRUG

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.

Control Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (105)

Arizona Oncology Associates

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

New York Presbyterian Queens

Flushing, New York, 11355, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Laura and Issac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

First Health of the Carolinas Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Oncology, P.A.

Austin, Texas, 78745, United States

Location

St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Northern NSW Health District, The Tweed Hospital

Tweed Heads, New South Wales, 2485, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4011, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 03000, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

St. John of God Subiaco Hospital

Subiaco, Western Australia, 6008, Australia

Location

OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie

Aalst, 9300, Belgium

Location

Institut Bordet

Brussels, 1000, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

UZLeuven Gynaelologic Oncology

Leuven, 3000, Belgium

Location

CHC Saint Joseph

Liège, 4000, Belgium

Location

CHU Liège

Liège, 4000, Belgium

Location

CHU UCL Namur site Sainte Elisabeth

Namur, 5000, Belgium

Location

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hosptial Sao Lucas da PUC de Porto Alegre

Porto Alegre, Rio Grande do Sul, 09619-900, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-072, Brazil

Location

Centro de Novos Tratamentos Itajai

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM

Caxias do Sul, 95070-560, Brazil

Location

Instituto Nacional de Cancer - INCA

Rio de Janeiro, 20220-410, Brazil

Location

Instituto COI de Pesquisa

Rio de Janeiro, 22793-080, Brazil

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N4N2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

Location

Hospital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

General Hospital of Athens Alexandra

Athens, 11528, Greece

Location

University Hospital of Ioannina

Ioannina, 45110, Greece

Location

General Hospital of Patras

Pátrai, 26335, Greece

Location

Euromedica General Clinic, B'Oncology Clinic

Thessaloniki, 54645, Greece

Location

Azienda Ospedaliero Universitaria di Bologna

Bologna, 40138, Italy

Location

U.O Oncologia Medica P.O Vito Fazzi

Lecce, 73100, Italy

Location

Asst Lecco

Lecco, 23900, Italy

Location

Irst Irccs

Meldola, 47014, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

AUSL, IRCCS di Reggio Emilia

Reggio Emilia, 42122, Italy

Location

Fondazione Policlinico Agostino Gemelli IRCCS di Roma

Roma, 00168, Italy

Location

Regina Elena National Cancer Institute

Rome, 00144, Italy

Location

Shikoku Cancer Center

Matsuyama, Ehime, 791-0281, Japan

Location

Ehime University Hospital

Tōon, Ehime, 791-0296, Japan

Location

Fukui University Hospital

Yoshida-gun, Fukui, 910-1194, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0012, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8649, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, 216-8512, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, Okinawa, 903-0216, Japan

Location

Saitama Medical University

Saitama, Saitama, 350-0495, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0046, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, 135-8551, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8612, Japan

Location

Saitama Cancer Center

Saitama, Tokyo, 362-0806, Japan

Location

National Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kagoshima City Hospital

Kagoshima, 890-8761, Japan

Location

Bialostockie Centrum Onkologii

Bialystok, 15-027, Poland

Location

Szpitale Pomorskie

Gdynia, 81-519, Poland

Location

Center and Institute of Oncology Gliwice

Gliwice, 44-101, Poland

Location

Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli

Lublin, 20-090, Poland

Location

Greater Poland Cancer Center

Poznan, 61-866, Poland

Location

Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary

Ivanovo, Ivanovo Oblast, 153040, Russia

Location

State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic

Nal'chik, Kabardino-Balkarian, 360000, Russia

Location

A. Tsyb Medical Radiological Research Center

Obninsk, Kaluga Oblast, 249036, Russia

Location

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

Krasnodar, Krasnodar Territory, 350040, Russia

Location

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

Vsevolozhsk, Leningradskaya Oblast', 188663, Russia

Location

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

Kazan', Tatarstan Republic, 420029, Russia

Location

Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

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

Orenburg, 460021, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Vall d´Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Instituto Catalan de Oncologia de Gerona

Girona, 17007, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario HM Sanchinarro CIOCC

Madrid, 28050, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Fundacion Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

Koo-Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

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

Glasgow, G12 0YN, United Kingdom

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Royal Marsden NHS Foundation Trust, Chelsea

London, SW3 6JJ, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Royal Marsden NHS Foundation Trust, Sutton

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35922251 DERIVED

• 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.

  PMID: 35139273 DERIVED

Related Links

• A Plain Language Summary is available on TrialSummaries.com

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Recurrence; Neoplasm Metastasis

Interventions

cemiplimab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 22, 2017
• Study Start: September 5, 2017
• Primary Completion: March 15, 2021
• Study Completion: April 20, 2023
• Last Updated: April 8, 2025
• Results First Posted: April 6, 2022

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

ES (10); GB (6); US (11); GR (4); BE (7); PL (5); KR (6); JP (14); BR (8); AU (6); CA (7); TW (4); IT (8); RU (9)