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

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 105 人开始时间: 2021年5月20日最近更新: 2023年11月20日

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•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

•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

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