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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04646005

Collaborator

ISA Pharmaceuticals B.V. (Industry)

105

Enrollment

Locations

Arm

39.8

Anticipated Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: Cemiplimab Biological: ISA101b	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 28, 2021

Anticipated Primary Completion Date :

Oct 22, 2024

Anticipated Study Completion Date :

Oct 22, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [Until disease progression, up to 36 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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 Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Associates	Tucson	Arizona	United States	85704
2	Arizona Oncology Associates	Tucson	Arizona	United States	85711
3	Regeneron Research Site	Orange	California	United States	92868
4	Yale University School of Medicine	New Haven	Connecticut	United States	06510
5	Northwell Health - Monter Cancer Center	Lake Success	New York	United States	11042
6	University of Texas Health Science Center	Houston	Texas	United States	77030
7	Universitair Ziekenhuis Gent	Gent	East Flanders	Belgium	9000
8	UZ Leuven	Leuven	Vlaams Brabant	Belgium	3000
9	CHIREC Delta Hospital / Chirec Cancer Institute	Brussels		Belgium	1160
10	Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA	Santo Cristo	Rio De Janeiro	Brazil	20220-410
11	Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
12	Centro De Novos Tratamentos Itajai	Itajai	Santa Catarina	Brazil	88301-220
13	Fundacao Pio XII - Hospital de Cancer de Barretos	Barretos	Sao Paulo	Brazil	14784-400
14	Regeneron Research Site	Rio de Janeiro		Brazil	22793-080
15	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS	Meldola	Emilia-Romagna	Italy	47014
16	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio	Italy	00168
17	IRCCS-Istituto Europeo di Oncologia	Milan		Italy	20141
18	Seoul National University Hospital	Seoul		Korea, Republic of	03080
19	University of Ulsan College of Medicine - Asan Medical Center (AMC)	Seoul		Korea, Republic of	05505
20	Gangnam Severance Hospital	Seoul		Korea, Republic of	06273
21	Korea University Guro Hospital	Seoul		Korea, Republic of	08308
22	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6229 HX
23	University Medical Center Groningen	Groningen		Netherlands	9713 GZ
24	Leiden Universitair Medisch Centrum (LUMC)	Leiden		Netherlands	2333 ZA
25	Radboudumc	Nijmegen		Netherlands	6525 GA
26	Regional Budgetary Healthcare Institution Ivanovo Regional Oncology Dispensary	Ivanovo	Ivanovo Region	Russian Federation	153040
27	State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region	Krasnodar	Krasnodar Region	Russian Federation	350040
28	State Budgetary Healthcare Institution Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman (GBUZ LOKOD)	Vsevolozhskiy District	Leningrad Region	Russian Federation	188663
29	Regeneron Research Site	Saint-Petersburg	Saint-Petersburg Region	Russian Federation	197341
30	Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO)	Girona	Catalonia	Spain	17007
31	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
32	Hospital Universitario La Paz	Madrid		Spain	28046