ClinicalTrials.gg
CompletedNCT03257267Updated Apr 8, 2025Results posted

Study of Cemiplimab in Adults With Cervical Cancer

A Phase 3 interventional study of Cemiplimab and Investigator Choice (IC) Chemotherapy in Squamous Cell Carcinoma (SCC) and Recurrent or Metastatic, Platinum-refractory Cervical Cancer, sponsored by Regeneron Pharmaceuticals. Completed at 105 sites in 14 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
608
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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)
02

Conditions studied

  • Squamous Cell Carcinoma (SCC)
  • Recurrent or Metastatic, Platinum-refractory Cervical Cancer
03

In context

Carcinoma, Squamous Cell

627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.

This study's enrollment of 608 is above the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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:

  1. Recurrent, persistent, and/or 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 as defined by 1.1.
  4. (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 disease that required treatment with systemic treatments
  2. Prior treatment with an agent that blocks the /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
  5. Immunosuppressive 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 reaction attributed to antibody treatments
  9. Concurrent 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

Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
608 participants (actual)

Study arms

  • Experimental
    Experimental Therapy

    Cemiplimab

    Drug: Cemiplimab

  • Active comparator
    Control Therapy

    Investigator choice (IC) chemotherapy

    Drug: Investigator Choice (IC) Chemotherapy

Interventions

  • Intravenous (IV) administration every 3 weeks (Q3W)

    Also known as: REGN2810, Libtayo

  • DrugInvestigator 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.

06

What researchers measure

Primary outcomes

  1. 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 frame: From first dose up to 90 following last dose (~42 months)

  2. 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.

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

Secondary outcomes

  1. 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 did 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)

  2. 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.

    Time frame: From date of randomization up to 40 months

  3. 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 progressed 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)

  4. 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.

    Time frame: From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)

  5. 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 Treatment-emergent adverse event (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 first dose up to 90 following last dose (~36 months)

  6. 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.

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

07

Results

Posted Apr 6, 2022

Participant flow

Participant flow — Overall Study
MilestoneCemiplimabInvestigator Choice (IC) Chemotherapy
Started304304
Full analysis set (fas)304304
Safety analysis set (saf)300290
Completed treatment380
Completed350
Not completed269304
Withdrew: Adverse event177
Withdrew: Death9698
Withdrew: Lost to follow-up22
Withdrew: Non-compliance with study drug02
Withdrew: Participant decision3543
Withdrew: Sponsor decision10
Withdrew: Physician decision13
Withdrew: Disease progression109121
Withdrew: Withdrawal by subject826
Withdrew: Other02

Outcome measures

PrimaryOverall 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 frame:
From first dose up to 90 following last dose (~42 months)
Reported as:
Median · Months
Overall Survival (OS)
MonthsCemiplimabInvestigator Choice (IC) Chemotherapy
Overall Survival (OS)11.7 (9.6 to 13.4)8.5 (7.5 to 9.6)
Statistical analysis
  • Cemiplimab vs Investigator Choice (IC) Chemotherapy · Stratified Log-rank Test · p = <0.00001 (One-sided p-value) · Hazard ratio (hr): 0.665 · 95% CI 0.555 to 0.796
SecondaryProgression-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 did 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)
Reported as:
Median · Months
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
MonthsCemiplimabInvestigator Choice (IC) Chemotherapy
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)2.8 (2.6 to 3.9)2.9 (2.7 to 3.5)
Statistical analysis
  • Cemiplimab vs Investigator Choice (IC) Chemotherapy · Stratified Log-rank Test · p = 0.00031 · Hazard ratio (hr): 0.741 · 95% CI 0.623 to 0.882
SecondaryObjective 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.

Time frame:
From date of randomization up to 40 months
Reported as:
Count of participants · Participants
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
ParticipantsCemiplimabInvestigator Choice (IC) Chemotherapy
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.15219
Statistical analysis
  • Cemiplimab vs Investigator Choice (IC) Chemotherapy · Stratified Cochran-Mantel-Haenszel test · p = 0.00002 · Odds ratio (or): 3.136 · 95% CI 1.798 to 5.468
SecondaryDuration 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 progressed 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)
Reported as:
Median · Months
Duration of Response (DOR) Assessed Per RECIST 1.1
MonthsCemiplimabInvestigator Choice (IC) Chemotherapy
Duration of Response (DOR) Assessed Per RECIST 1.118.7 (16.4 to NA)7.2 (5.1 to 9.9)
SecondaryQuality 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.

Time frame:
From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
Reported as:
Least squares mean · Score on a Scale
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
Score on a ScaleCemiplimabInvestigator Choice (IC) Chemotherapy
Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL0.46 (-2.715 to 3.642)-8.54 (-13.004 to -4.084)
Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning-0.27 (-3.014 to 2.473)-8.86 (-12.517 to -5.196)
SecondaryNumber 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 Treatment-emergent adverse event (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 first dose up to 90 following last dose (~36 months)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
ParticipantsCemiplimabInvestigator Choice (IC) Chemotherapy
Participants with any TEAE269266
Participants with any Serious TEAE9678
Participants with any TEAE leading to Death52
SecondaryNumber 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.

Time frame:
From first dose up to 90 following last dose (~36 months)
Reported as:
Count of participants · Participants
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
ParticipantsCemiplimabInvestigator Choice (IC) Chemotherapy
Hematology (Grades 3/4)84137
Electrolytes (Grades 3/4)4732
Chemistry (Other) (Grades 3/4)1210
Liver Function (Grades 3/4)2823
PrimaryOverall 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.

Time frame:
From first dose up to 90 following last dose (~42 months)
Reported as:
Median · Months
Overall Survival (OS) in the SCC Population
MonthsCemiplimabInvestigator Choice (IC) Chemotherapy
Overall Survival (OS) in the SCC Population10.9 (8.9 to 12.9)8.8 (7.6 to 9.8)
Statistical analysis
  • Cemiplimab vs Investigator Choice (IC) Chemotherapy · Stratified Log-rank Test · p = 0.00024 (One-sided p-value) · Hazard ratio (hr): 0.698 · 95% CI 0.570 to 0.855

Adverse events

Collected over From first dose up to 90 following last dose (~42 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cemiplimab234/300 (78%)100/300 (33.3%)239/300 (79.7%)
Chemotherapy*249/290 (85.9%)84/290 (29%)253/290 (87.2%)
Chemotherapy to Cemiplimab*2/8 (25%)1/8 (12.5%)4/8 (50%)
Most frequent serious events
Showing 10 of 147
Most frequent serious events
EventCemiplimabChemotherapy*Chemotherapy to Cemiplimab*
VomitingGastrointestinal disorders2/3003/2901/8
NauseaGastrointestinal disorders2/3000/2901/8
Urinary tract infectionInfections and infestations15/30011/2900/8
AnaemiaBlood and lymphatic system disorders3/30014/2900/8
Febrile neutropeniaBlood and lymphatic system disorders3/3006/2900/8
PyrexiaGeneral disorders4/3006/2900/8
PneumoniaInfections and infestations5/3003/2900/8
Acute kidney injuryRenal and urinary disorders5/3003/2900/8
PyelonephritisInfections and infestations4/3003/2900/8
Autoimmune hepatitisHepatobiliary disorders4/3000/2900/8
Most frequent other events
Showing 10 of 38
Most frequent other events
EventCemiplimabChemotherapy*Chemotherapy to Cemiplimab*
AnaemiaBlood and lymphatic system disorders79/300128/2900/8
NauseaGastrointestinal disorders63/300100/2900/8
PyrexiaGeneral disorders36/30062/2902/8
VomitingGastrointestinal disorders49/30066/2900/8
ConstipationGastrointestinal disorders46/30058/2901/8
FatigueGeneral disorders52/30045/2900/8
Decreased appetiteMetabolism and nutrition disorders46/30046/2900/8
NeutropeniaBlood and lymphatic system disorders9/30045/2900/8
AstheniaGeneral disorders35/30045/2900/8
DiarrhoeaGastrointestinal disorders35/30041/2901/8

Baseline characteristics

The FAS included all randomized participants.

Age, Continuous
Age, Continuous(Years)CemiplimabInvestigator Choice (IC) ChemotherapyTotal
Mean51.1 ± 11.5951.2 ± 11.7751.1 ± 11.67
Sex: Female, Male
Sex: Female, Male(Participants)CemiplimabInvestigator Choice (IC) ChemotherapyTotal
Female304304608
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CemiplimabInvestigator Choice (IC) ChemotherapyTotal
Hispanic or Latino474491
Not Hispanic or Latino251250501
Unknown or Not Reported61016
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CemiplimabInvestigator Choice (IC) ChemotherapyTotal
White193192385
Black or African American91221
Asian8888176
American Indian or Alaska Native213
Other8412
Unknown112
Not Reported369
08

Study locations

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

Showing the first 100 of 105 sites across 14 countries. Choose a country and city above to see the rest.

09

References and documents

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. PubMed 35922251 ↗
  • 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. PubMed 35139273 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Mar 2021, 42 months.

Results were first posted in Apr 2022, 1 year after primary completion.

Of 21 phase 3 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 91. This study's 42 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2017
First posted
Aug 22, 2017
StartActual
Sep 5, 2017
Primary completionActual
Mar 15, 2021
CompletionActual
Apr 20, 2023
Results first posted
Apr 6, 2022
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03257267
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Sep 5, 2017
Primary completion
Mar 15, 2021
Completion
Apr 20, 2023
Results posted
Apr 6, 2022
Last update
Apr 8, 2025

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Cemiplimab

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