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

Phase 1

• Conditions: Recurrent/Metastatic HPV16 Cervical Cancer; MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10008231Term: Cervical cancer recurrentSystem Organ Class: 100000004864; MedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001239-29-IT
• Lead Sponsor: REGENERON PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 103

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 squamous cell cervical cancer, 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. ECOG performance status of 0 or 1.
6. Has adequate organ and bone marrow function as defined in the protocol.
7. Anticipated life expectancy =20 weeks.

Other protocol-defined Inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Other protocol-defined Exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: The secondary objectives of the study are:<br>- To characterize the safety profile of cemiplimab + ISA101b<br>- To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS);Primary end point(s): Objective response rate (ORR);Timepoint(s) of evaluation of this end point: Up to 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence and severity of treatment emergent adverse events (TEAEs)<br>2. Incidence and severity of adverse events of special interest (AESIs)<br>3. Incidence and severity of serious adverse events (SAEs)<br>4. Incidence and severity of = grade 3 laboratory abnormalities<br>5. Duration of response (DOR)<br>6. Progression free survival (PFS) <br>7. Overall survival (OS);Timepoint(s) of evaluation of this end point: 1-4: Up to 90 days after the last dose of study treatment<br>5-7: Up to 36 months