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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03257267
Registration number
NCT03257267
Ethics application status
Date submitted
26/07/2017
Date registered
22/08/2017
Date last updated
11/07/2023
Titles & IDs
Public title
Study of Cemiplimab in Adults With Cervical Cancer
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Scientific title
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
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Secondary ID [1]
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2017-000350-19
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Secondary ID [2]
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R2810-ONC-1676
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma (SCC)
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Recurrent or Metastatic, Platinum-refractory Cervical Cancer
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
0
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Womb (Uterine or endometrial cancer)
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Cancer
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cemiplimab
Treatment: Drugs - Investigator Choice (IC) Chemotherapy
Experimental: Experimental Therapy - Cemiplimab
Active Comparator: Control Therapy - Investigator choice (IC) chemotherapy
Treatment: Drugs: Cemiplimab
Intravenous (IV) administration every 3 weeks (Q3W)
Treatment: Drugs: Investigator Choice (IC) Chemotherapy
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Time from randomization to the date of death due to any cause (assessed up to 40 months)
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Secondary outcome [1]
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Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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Assessment method [1]
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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.
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Timepoint [1]
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Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
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Secondary outcome [2]
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Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
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Assessment method [2]
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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.
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Timepoint [2]
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From date of randomization up to 40 months
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Secondary outcome [3]
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Duration of Response (DOR) Assessed Per RECIST 1.1
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Assessment method [3]
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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.
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Timepoint [3]
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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)
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
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Secondary outcome [5]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
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Assessment method [5]
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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.
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Timepoint [5]
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From date of randomization up to 40 months
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Secondary outcome [6]
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Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
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Assessment method [6]
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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.
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Timepoint [6]
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From date of randomization up to 40 months
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Eligibility
Key inclusion criteria
The criteria listed below are not intended to contain all considerations relevant to a
patient's potential participation in this clinical trial.
Key
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/04/2023
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Sample size
Target
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Accrual to date
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Final
608
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St. George Hospital - Kogarah
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Recruitment hospital [2]
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Northern NSW Health District, The Tweed Hospital - Tweed Heads
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Recruitment hospital [3]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [6]
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St. John of God Subiaco Hospital - Subiaco
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2217 - Kogarah
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2485 - Tweed Heads
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Recruitment postcode(s) [3]
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4011 - Herston
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Recruitment postcode(s) [4]
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03000 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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6008 - Subiaco
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Recruitment outside Australia
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Bruxelles
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Liège
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Nottingham
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Address
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Other collaborator category [1]
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Sanofi
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Ethics approval
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Summary
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)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03257267
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trial Management
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Address
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Regeneron Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03257267
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