A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)
Overview
- Phase
- Phase 2
- Intervention
- ISA101b
- Conditions
- Squamous Cell Carcinoma of the Oropharynx
- Sponsor
- ISA Pharmaceuticals
- Enrollment
- 194
- Locations
- 44
- Primary Endpoint
- Overall Response Rate
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.
Detailed Description
This study will assess the ability of ISA101b to improve Overall Response Rate in subjects with HPV16 positive OPC, when combined with cemiplimab, an investigational anti-PD-1 antibody being developed by Regeneron Pharmaceuticals. ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16. Trials in HPV16 driven malignancies indicate it has activity in HPV16 driven malignancies including oropharyngeal and cervical cancers. Cemiplimab, also known as REGN2810, is in late stage trials and appears to have similar activity to approved anti PD-1 antibodies in a number of malignancies .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, ≥ 18 years of age.
- •Sign and date an Institutional Review Board/Independent Ethics Committee (IRB)/(IEC)-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
- •Be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- •Diagnosed with histologically confirmed recurrent or metastatic HPV16 positive OPC, whose tumors express PD-L1 (Combined Positive Score \[CPS\] ≥1) and who are candidates for first line therapy with an PD-1 blocking antibody, AND subjects with recurrent or metastatic HPV16 positive OPC with disease progression on or after platinum containing chemotherapy.
- •HPV-16 genotyping will be determined by the specified central reference laboratory.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
- •Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration.
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of study drug.
- •Exclusion criteria:
Exclusion Criteria
- Not provided
Arms & Interventions
Active ISA101b and cemiplimab.
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
Intervention: ISA101b
Active ISA101b and cemiplimab.
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
Intervention: Cemiplimab
Placebo and cemiplimab
Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months
Intervention: Cemiplimab
Placebo and cemiplimab
Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months
Intervention: Placebo
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: 25months
Measured using RECIST 1.1
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 "Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0".
Time Frame: 25 months
Secondary Outcomes
- Duration of response (DOR) by independent review in subjects randomized to receive ISA101b plus cemiplimab compared to placebo plus cemiplimab.(25months)