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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03257267




Registration number
NCT03257267
Ethics application status
Date submitted
26/07/2017
Date registered
22/08/2017

Titles & IDs
Public title
Study of Cemiplimab in Adults With Cervical Cancer
Scientific title
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Secondary ID [1] 0 0
2017-000350-19
Secondary ID [2] 0 0
R2810-ONC-1676
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma (SCC) 0 0
Recurrent or Metastatic, Platinum-refractory Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
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:

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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From first dose up to 90 following last dose (~42 months)
Primary outcome [2] 0 0
Overall Survival (OS) in the SCC Population
Timepoint [2] 0 0
From first dose up to 90 following last dose (~42 months)
Secondary outcome [1] 0 0
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Timepoint [1] 0 0
Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
Timepoint [2] 0 0
From date of randomization up to 40 months
Secondary outcome [3] 0 0
Duration of Response (DOR) Assessed Per RECIST 1.1
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
Secondary outcome [5] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
Timepoint [5] 0 0
From first dose up to 90 following last dose (~36 months)
Secondary outcome [6] 0 0
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
Timepoint [6] 0 0
From first dose up to 90 following last dose (~36 months)

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2023
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Northern NSW Health District, The Tweed Hospital - Tweed Heads
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
St. John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
4011 - Herston
Recruitment postcode(s) [4] 0 0
03000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Aalst
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Belgium
State/province [14] 0 0
Namur
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio Grande Do Norte
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande Do Sul
Country [17] 0 0
Brazil
State/province [17] 0 0
Santa Catarina
Country [18] 0 0
Brazil
State/province [18] 0 0
São Paulo
Country [19] 0 0
Brazil
State/province [19] 0 0
Caxias do Sul
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio de Janeiro
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Greece
State/province [25] 0 0
Athens
Country [26] 0 0
Greece
State/province [26] 0 0
Ioannina
Country [27] 0 0
Greece
State/province [27] 0 0
Patras
Country [28] 0 0
Greece
State/province [28] 0 0
Thessaloniki
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Italy
State/province [30] 0 0
Lecce
Country [31] 0 0
Italy
State/province [31] 0 0
Lecco
Country [32] 0 0
Italy
State/province [32] 0 0
Meldola
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Reggio Emilia
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Italy
State/province [36] 0 0
Rome
Country [37] 0 0
Japan
State/province [37] 0 0
Ehime
Country [38] 0 0
Japan
State/province [38] 0 0
Fukui
Country [39] 0 0
Japan
State/province [39] 0 0
Fukuoka
Country [40] 0 0
Japan
State/province [40] 0 0
Hokkaido
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Okinawa
Country [43] 0 0
Japan
State/province [43] 0 0
Saitama Prefecture
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo
Country [45] 0 0
Japan
State/province [45] 0 0
Kagoshima
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Gyeonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Daegu
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Poland
State/province [49] 0 0
Bialystok
Country [50] 0 0
Poland
State/province [50] 0 0
Gdynia
Country [51] 0 0
Poland
State/province [51] 0 0
Gliwice
Country [52] 0 0
Poland
State/province [52] 0 0
Lublin
Country [53] 0 0
Poland
State/province [53] 0 0
Poznan
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Ivanovo Region
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Kabardino-Balkarian
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Kaluga
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Krasnodar Territory
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Leningrad Region
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Tatarstan
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Omsk
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Orenburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint Petersburg
Country [63] 0 0
Spain
State/province [63] 0 0
Illes Balears
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Spain
State/province [65] 0 0
Cordoba
Country [66] 0 0
Spain
State/province [66] 0 0
Girona
Country [67] 0 0
Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Malaga
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Spain
State/province [70] 0 0
Zaragoza
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taichung
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taipei City
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taipei
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Cardiff
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Glasgow
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Nottingham
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
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
Available to whom?
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03257267