Clinical trial NCT04646005: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: HPV16 positive
Squamous histology
Recurrent
Metastatic
Adenocarcinoma/adenosquamous histology
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: ISA Pharmaceuticals B.V.
First posted: 2020-11-27
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility 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 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From enrollment to last dose (~up to 23 months)
Secondary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Number of Participants With Any Serious TEAE
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Number of Participants With at Least One Lab Abnormality
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Duration of Response (DOR)
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Progression Free Survival (PFS)
timeFrame: From enrollment to last dose (~up to 23 months)
measure: Overall Survival (OS)
timeFrame: From enrollment to last dose (~up to 23 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Orange
country: United States
facility: Regeneron Research Site
state: California
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: East Flanders
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Brussels
country: Belgium
facility: CHIREC Delta Hospital / Chirec Cancer Institute
city: Santo Cristo
country: Brazil
facility: Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Centro De Novos Tratamentos Itajai
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Milan
country: Italy
facility: IRCCS-Istituto Europeo di Oncologia
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: University of Ulsan College of Medicine - Asan Medical Center (AMC)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden Universitair Medisch Centrum (LUMC)
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
state: Krasnodar Region
city: Girona
country: Spain
facility: Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: