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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04646005
• Other study ID #: R2810-ONC-ISA-1981
• Secondary ID: 2020-001239-29
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 28, 2021
• Est. completion date: October 22, 2024

Study information

• Verified date: September 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: October 22, 2024
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Disease Progression
• Uterine Cervical Neoplasms

Intervention

Drug:
• Cemiplimab
Administered intravenously (IV) every three weeks (Q3W)

Biological:
• ISA101b
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	ISA Pharmaceuticals B.V.

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Italy,  Korea, Republic of,  Netherlands,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)		Until disease progression, up to 36 months
Secondary	Incidence and severity of treatment emergent adverse events (TEAEs)		Up to 90 days after the last dose of study treatment
Secondary	Incidence and severity of adverse events of special interest (AESIs)		Up to 90 days after the last dose of study treatment
Secondary	Incidence and severity of serious adverse events (SAEs)		Up to 90 days after the last dose of study treatment
Secondary	Incidence and severity of = grade 3 laboratory abnormalities		Up to 90 days after the last dose of study treatment
Secondary	Duration of response (DOR)		Until disease progression, up to 36 months
Secondary	Progression free survival (PFS)		Until disease progression, up to 36 months
Secondary	Overall survival (OS)		Up to 60 months