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Trial record 1 of 1 for:    NCT04646005
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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 : August 26, 2022
Sponsor:
Collaborator:
ISA Pharmaceuticals B.V.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 20, 2020
First Posted Date  ICMJE November 27, 2020
Last Update Posted Date August 26, 2022
Actual Study Start Date  ICMJE June 28, 2021
Estimated Primary Completion Date October 22, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
Objective response rate (ORR) [ Time Frame: Until disease progression, up to 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 90 days after the last dose of study treatment ]
  • Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Up to 90 days after the last dose of study treatment ]
  • Incidence and severity of serious adverse events (SAEs) [ Time Frame: Up to 90 days after the last dose of study treatment ]
  • Incidence and severity of ≥ grade 3 laboratory abnormalities [ Time Frame: Up to 90 days after the last dose of study treatment ]
  • Duration of response (DOR) [ Time Frame: Until disease progression, up to 36 months ]
  • Progression free survival (PFS) [ Time Frame: Until disease progression, up to 36 months ]
  • Overall survival (OS) [ Time Frame: Up to 60 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Cemiplimab+ISA101b
Interventions:
  • Drug: Cemiplimab
  • Biological: ISA101b
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2021)
105
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2020)
103
Estimated Study Completion Date  ICMJE October 22, 2024
Estimated Primary Completion Date October 22, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 cervical cancer as determined by an investigational HPV16 PCR assay, 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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Belgium,   Brazil,   Italy,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04646005
Other Study ID Numbers  ICMJE R2810-ONC-ISA-1981
2020-001239-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ISA Pharmaceuticals B.V.
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP