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

NCT04646005 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: R2810-ONC-ISA-19812020-001239-29
• Study Type: interventional
• Target: 113
• Locations: 8 countries
• Sites: 26

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)

Conditions

Cervical Cancer

Keywords

HPV16 positive; Squamous histology; Recurrent; Metastatic; Adenocarcinoma/adenosquamous histology

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).

  From enrollment to last dose (~up to 23 months)

Secondary Outcomes (9)

• Number of Treatment Emergent Adverse Events (TEAEs)

  From enrollment to last dose (~up to 23 months)

• Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)

  From enrollment to last dose (~up to 23 months)

• Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)

  From enrollment to last dose (~up to 23 months)

• Number of Participants With Any Serious TEAE

  From enrollment to last dose (~up to 23 months)

• Number of Participants With at Least One Lab Abnormality

  From enrollment to last dose (~up to 23 months)

Study Arms (1)

Cemiplimab+ISA101b

EXPERIMENTAL

Drug: Cemiplimab; Biological: ISA101b

Interventions

Cemiplimab DRUG

Administered intravenously (IV) every three weeks (Q3W)

Also known as: REGN2810, Libtayo

Cemiplimab+ISA101b

ISA101b BIOLOGICAL

Administered by subcutaneous (SC) injection on day 1, day 29, and day 50

Cemiplimab+ISA101b

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• ISA Pharmaceuticals B.V.: collaborator

Study Sites (26)

Arizona Oncology Associates

Tucson, Arizona, 85704, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

Location

Regeneron Research Site

Orange, California, 92868, United States

Location

Universitair Ziekenhuis Gent

Ghent, East Flanders, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

CHIREC Delta Hospital / Chirec Cancer Institute

Brussels, 1160, Belgium

Location

Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA

Santo Cristo, Rio de Janeiro, 20220-410, Brazil

Location

Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Centro De Novos Tratamentos Itajai

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)

Rio de Janeiro, 22793-080, Brazil

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

IRCCS-Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Leiden Universitair Medisch Centrum (LUMC)

Leiden, 2333 ZA, Netherlands

Location

Radboudumc

Nijmegen, 6525 GA, Netherlands

Location

State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region

Krasnodar, Krasnodarskiy Kray, 350040, Russia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

University of Ulsan College of Medicine - Asan Medical Center (AMC)

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)

Girona, Catalonia, 17007, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Links

• A Plain Language Summary is available on TrialSummaries.com

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Recurrence; Neoplasm Metastasis; Adenocarcinoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: June 28, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 29, 2024
• Last Updated: September 8, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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

Locations

IT (3); BE (3); US (3); BR (5); ES (3); NL (4); RU (1); KR (4)