Back to resultsCemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy
Primary Purpose
Cervical Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cemiplimab
ISA101b
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring HPV16 positive, Squamous histology, Recurrent, Metastatic, Adenocarcinoma/adenosquamous histology
Eligibility Criteria
Key Inclusion Criteria:
- Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
- 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
- Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
- Patient must have measurable disease as defined by RECIST 1.1.
- Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
- ECOG performance status of 0 or 1.
- Has adequate organ and bone marrow function as defined in the protocol.
- Anticipated life expectancy ≥20 weeks.
Key Exclusion Criteria:
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Prior treatment with other systemic immune-modulating agents as defined in the protocol
- Major surgery or radiation therapy within 14 days of first administration of study drug
- 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
- 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
- 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
Sites / Locations
- Arizona Oncology Associates
- Arizona Oncology Associates
- Regeneron Research Site
- Universitair Ziekenhuis Gent
- UZ Leuven
- CHIREC Delta Hospital / Chirec Cancer Institute
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
- Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
- Centro De Novos Tratamentos Itajai
- Fundacao Pio XII - Hospital de Cancer de Barretos
- Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- IRCCS-Istituto Europeo di Oncologia
- Seoul National University Hospital
- University of Ulsan College of Medicine - Asan Medical Center (AMC)
- Gangnam Severance Hospital
- Korea University Guro Hospital
- Maastricht University Medical Center
- University Medical Center Groningen
- Leiden Universitair Medisch Centrum (LUMC)
- Radboudumc
- State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
- Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
- Hospital Universitari Vall d'Hebron
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cemiplimab+ISA101b
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
Secondary Outcome Measures
Incidence and severity of treatment emergent adverse events (TEAEs)
Incidence and severity of adverse events of special interest (AESIs)
Incidence and severity of serious adverse events (SAEs)
Incidence and severity of ≥ grade 3 laboratory abnormalities
Duration of response (DOR)
Progression free survival (PFS)
Overall survival (OS)
Full Information
NCT ID
NCT04646005
First Posted
November 20, 2020
Last Updated
October 2, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
ISA Pharmaceuticals B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04646005
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
October 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
ISA Pharmaceuticals B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
HPV16 positive, Squamous histology, Recurrent, Metastatic, Adenocarcinoma/adenosquamous histology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cemiplimab+ISA101b
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Administered intravenously (IV) every three weeks (Q3W)
Intervention Type
Biological
Intervention Name(s)
ISA101b
Intervention Description
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
Until disease progression, up to 36 months
Secondary Outcome Measure Information:
Title
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame
Up to 90 days after the last dose of study treatment
Title
Incidence and severity of adverse events of special interest (AESIs)
Time Frame
Up to 90 days after the last dose of study treatment
Title
Incidence and severity of serious adverse events (SAEs)
Time Frame
Up to 90 days after the last dose of study treatment
Title
Incidence and severity of ≥ grade 3 laboratory abnormalities
Time Frame
Up to 90 days after the last dose of study treatment
Title
Duration of response (DOR)
Time Frame
Until disease progression, up to 36 months
Title
Progression free survival (PFS)
Time Frame
Until disease progression, up to 36 months
Title
Overall survival (OS)
Time Frame
Up to 60 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
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
Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
Patient must have measurable disease as defined by RECIST 1.1.
Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
ECOG performance status of 0 or 1.
Has adequate organ and bone marrow function as defined in the protocol.
Anticipated life expectancy ≥20 weeks.
Key Exclusion Criteria:
Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
Prior treatment with other systemic immune-modulating agents as defined in the protocol
Major surgery or radiation therapy within 14 days of first administration of study drug
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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Regeneron Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHIREC Delta Hospital / Chirec Cancer Institute
City
Brussels
ZIP/Postal Code
1160
Country
Belgium
Facility Name
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
City
Santo Cristo
State/Province
Rio De Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Centro De Novos Tratamentos Itajai
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS-Istituto Europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
University of Ulsan College of Medicine - Asan Medical Center (AMC)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Leiden Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
City
Krasnodar
State/Province
Krasnodar Region
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
City
Girona
State/Province
Catalonia
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing 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.
IPD Sharing 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
IPD Sharing URL
https://vivli.org/
Learn more about this trial
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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