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
NCT ID: NCT04646005
Last Updated: 2025-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2021-06-28
2024-05-29
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cemiplimab+ISA101b
Cemiplimab
Administered intravenously (IV) every three weeks (Q3W)
ISA101b
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50
Interventions
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Cemiplimab
Administered intravenously (IV) every three weeks (Q3W)
ISA101b
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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ISA Pharmaceuticals B.V.
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Arizona Oncology Associates
Tucson, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Regeneron Research Site
Orange, California, United States
Universitair Ziekenhuis Gent
Ghent, East Flanders, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
CHIREC Delta Hospital / Chirec Cancer Institute
Brussels, , Belgium
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
Santo Cristo, Rio de Janeiro, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro De Novos Tratamentos Itajai
Itajaí, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
Rio de Janeiro, , Brazil
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
IRCCS-Istituto Europeo di Oncologia
Milan, , Italy
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leiden Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Radboudumc
Nijmegen, , Netherlands
State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
Krasnodar, Krasnodarskiy Kray, Russia
Seoul National University Hospital
Seoul, , South Korea
University of Ulsan College of Medicine - Asan Medical Center (AMC)
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
Girona, Catalonia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Summary is available on TrialSummaries.com
Other Identifiers
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2020-001239-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R2810-ONC-ISA-1981
Identifier Type: -
Identifier Source: org_study_id
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