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
- Conditions
- Cervical Cancer
- Interventions
- Registration Number
- NCT04646005
- Lead Sponsor
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 113
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cemiplimab+ISA101b Cemiplimab - Cemiplimab+ISA101b ISA101b -
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) From enrollment to last dose (~up to 23 months) Objective response rate (ORR) is determined by the proportion of patients with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).
- Secondary Outcome Measures
Name Time Method Number of Treatment Emergent Adverse Events (TEAEs) From enrollment to last dose (~up to 23 months) Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) With Severity of ≥ Grade 3 From enrollment to last dose (~up to 23 months) Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.Number of Participants With Any Adverse Events of Special Interest (AESIs) From enrollment to last dose (~up to 23 months) Number of Participants With Adverse Events of Special Interest (AESIs) With Severity of ≥ Grade 3 From enrollment to last dose (~up to 23 months) Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.Number of Participants With Serious Adverse Events (SAEs) From enrollment to last dose (~up to 23 months) Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Number of Participants With Serious Adverse Events (SAEs) With Severity of ≥ Grade 3 From enrollment to last dose (~up to 23 months) Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Number of Participants With at Least One Lab Abnormality From enrollment to last dose (~up to 23 months) Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3 From enrollment to last dose (~up to 23 months) Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Duration of Response (DOR) From enrollment to last dose (~up to 23 months) Progression Free Survival (PFS) From enrollment to last dose (~up to 23 months) Overall Survival (OS) From enrollment to last dose (~up to 23 months)
Trial Locations
- Locations (25)
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Universitair Ziekenhuis Gent
🇧🇪Gent, East Flanders, Belgium
CHIREC Delta Hospital / Chirec Cancer Institute
🇧🇪Brussels, Belgium
Centro De Novos Tratamentos Itajai
🇧🇷Itajai, Santa Catarina, Brazil
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Lazio, Italy
University Medical Center Groningen
🇳🇱Groningen, Netherlands
State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
🇷🇺Krasnodar, Krasnodar Region, Russian Federation
Regeneron Research Site
🇺🇸Orange, California, United States
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium
Hospital Universitario La Paz
🇪🇸Madrid, Spain
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
Fundacao Pio XII - Hospital de Cancer de Barretos
🇧🇷Barretos, Sao Paulo, Brazil
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
🇮🇹Meldola, Emilia-Romagna, Italy
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
🇧🇷Rio de Janeiro, Brazil
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
IRCCS-Istituto Europeo di Oncologia
🇮🇹Milan, Italy
University of Ulsan College of Medicine - Asan Medical Center (AMC)
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Leiden Universitair Medisch Centrum (LUMC)
🇳🇱Leiden, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
🇪🇸Girona, Catalonia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of