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-BE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 105

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 and as described in the protocol, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol. Acceptable histology is squamous carcinoma and adenocarcinoma/adenosquamous
carcinomas. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.
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 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

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