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Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

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ClinicalTrials.gov Identifier: NCT04646005
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : July 9, 2021
Sponsor:
Collaborator:
ISA Pharmaceuticals B.V.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).

The secondary objectives of the study are:

  • To characterize the safety profile of cemiplimab + ISA101b
  • To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Cemiplimab Biological: ISA101b Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : October 22, 2024
Estimated Study Completion Date : October 22, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Cemiplimab+ISA101b Drug: Cemiplimab
Administered intravenously (IV) every three weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo

Biological: ISA101b
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Until disease progression, up to 36 months ]

Secondary Outcome Measures :
  1. Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 90 days after the last dose of study treatment ]
  2. Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Up to 90 days after the last dose of study treatment ]
  3. Incidence and severity of serious adverse events (SAEs) [ Time Frame: Up to 90 days after the last dose of study treatment ]
  4. Incidence and severity of ≥ grade 3 laboratory abnormalities [ Time Frame: Up to 90 days after the last dose of study treatment ]
  5. Duration of response (DOR) [ Time Frame: Until disease progression, up to 36 months ]
  6. Progression free survival (PFS) [ Time Frame: Until disease progression, up to 36 months ]
  7. Overall survival (OS) [ Time Frame: Up to 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
  2. Has histologically confirmed recurrent or metastatic HPV16 positive squamous cell cervical cancer, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol
  3. Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
  4. Patient must have measurable disease as defined by RECIST 1.1.
  5. Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
  6. ECOG performance status of 0 or 1.
  7. Has adequate organ and bone marrow function as defined in the protocol.
  8. Anticipated life expectancy ≥20 weeks.

Key Exclusion Criteria:

  1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  2. Prior treatment with other systemic immune-modulating agents as defined in the protocol
  3. Major surgery or radiation therapy within 14 days of first administration of study drug
  4. Has received treatment with an approved systemic therapy within 4 weeks of first dose of study drug, or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
  5. Has another malignancy that is progressing or requires active treatment and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug as defined in the protocol
  6. Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 4 weeks prior to the first dose of study drug. 7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646005


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Arizona
Regeneron Research Site Recruiting
Tucson, Arizona, United States, 85704
Regeneron Research Site Recruiting
Tucson, Arizona, United States, 85711
United States, California
Regeneron Research Site Not yet recruiting
Orange, California, United States, 92868
United States, Connecticut
Regeneron Research Site Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, New York
Regeneron Research Site Not yet recruiting
Lake Success, New York, United States, 11042
United States, Texas
Regeneron Research Site Not yet recruiting
Houston, Texas, United States, 77030
Belgium
Regeneron Research Site Not yet recruiting
Brussels, Belgium, 1160
Regeneron Research Site Not yet recruiting
Gent, Belgium, 9000
Regeneron Research Site Not yet recruiting
Leuven, Belgium, 3000
Brazil
Regeneron Research Site Not yet recruiting
Santo Cristo, Rio De Janeiro, Brazil, 20220-410
Regeneron Research Site Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Regeneron Research Site Not yet recruiting
Itajai, Santa Catarina, Brazil, 88301-220
Regeneron Research Site Not yet recruiting
Barretos, Sao Paulo, Brazil, 14784-400
Regeneron Research Site Not yet recruiting
Rio de Janeiro, Brazil, 22793-080
Italy
Regeneron Research Site Not yet recruiting
Meldola, Emilia-Romagna, Italy, 47014
Regeneron Research Site Not yet recruiting
Roma, Lazio, Italy, 00168
Regeneron Research Site Not yet recruiting
Milan, Italy, 20141
Korea, Republic of
Regeneron Research Site Not yet recruiting
Seoul, Korea, Republic of, 03080
Regeneron Research Site Not yet recruiting
Seoul, Korea, Republic of, 05505
Regeneron Research Site Not yet recruiting
Seoul, Korea, Republic of, 06273
Regeneron Research Site Not yet recruiting
Seoul, Korea, Republic of, 08308
Netherlands
Regeneron Research Site Not yet recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Regeneron Research Site Not yet recruiting
Groningen, Netherlands, 9713 GZ
Regeneron Research Site Not yet recruiting
Leiden, Netherlands, 2333 ZA
Regeneron Research Site Not yet recruiting
Nijmegen, Netherlands, 6500 HB
Russian Federation
Regeneron Research Site Not yet recruiting
Ivanovo, Ivanovo Region, Russian Federation, 153040
Regeneron Research Site Not yet recruiting
Krasnodar, Krasnodar Region, Russian Federation, 350040
Regeneron Research Site Not yet recruiting
Vsevolozhskiy District, Leningrad Region, Russian Federation, 188663
Regeneron Research Site Not yet recruiting
Saint-Petersburg, Saint-Petersburg Region, Russian Federation, 197341
Spain
Regeneron Research Site Recruiting
Girona, Catalonia, Spain, 17007
Regeneron Research Site Recruiting
Barcelona, Spain, 08035
Sponsors and Collaborators
Regeneron Pharmaceuticals
ISA Pharmaceuticals B.V.
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04646005    
Other Study ID Numbers: R2810-ONC-ISA-1981
2020-001239-29 ( EudraCT Number )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
HPV16 positive
Squamous histology
Recurrent
Metastatic
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Disease Progression
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Disease Attributes
Pathologic Processes
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents