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

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Cemiplimab; Biological: ISA101b

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1160
    • CHIREC Delta Hospital / Chirec Cancer Institute
  • East Flanders
    • Gent, East Flanders, Belgium, 9000
      • Universitair Ziekenhuis Gent
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
  • Rio De Janeiro
    • Santo Cristo, Rio De Janeiro, Brazil, 20220-410
      • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Centro De Novos Tratamentos Itajai
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos
• Italy
  • Milan, Italy, 20141
    • IRCCS-Istituto Europeo di Oncologia
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • University of Ulsan College of Medicine - Asan Medical Center (AMC)
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Leiden, Netherlands, 2333 ZA
    • Leiden Universitair Medisch Centrum (LUMC)
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center
• Russian Federation
  • Krasnodar Region
    • Krasnodar, Krasnodar Region, Russian Federation, 350040
      • State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Catalonia
    • Girona, Catalonia, Spain, 17007
      • Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates
  • California
    • Orange, California, United States, 92868
      • Regeneron Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cemiplimab+ISA101b	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	Until disease progression, up to 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of treatment emergent adverse events (TEAEs)	Up to 90 days after the last dose of study treatment
Incidence and severity of adverse events of special interest (AESIs)	Up to 90 days after the last dose of study treatment
Incidence and severity of serious adverse events (SAEs)	Up to 90 days after the last dose of study treatment
Incidence and severity of ≥ grade 3 laboratory abnormalities	Up to 90 days after the last dose of study treatment
Duration of response (DOR)	Until disease progression, up to 36 months
Progression free survival (PFS)	Until disease progression, up to 36 months
Overall survival (OS)	Up to 60 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: ISA Pharmaceuticals B.V.
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): May 22, 2023
• Study Completion (Estimated): October 22, 2024

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic; Recurrent; HPV16 positive; Squamous histology; Adenocarcinoma/adenosquamous histology
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Disease Progression; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-ISA-1981; 2020-001239-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No