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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Cemiplimab
* Biological: ISA101b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cemiplimab+ISA101b<br> | Drug: Cemiplimab<br>* Administered intravenously (IV) every three weeks (Q3W)<br>* Other names: Libtayo;Biological: ISA101b<br>* Administered by subcutaneous (SC) injection on day 1, day 29, and day 50<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV16 positive, Squamous histology, Recurrent, Metastatic, Adenocarcinoma/adenosquamous histology