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
- cervical cancersquamous cell cervical cancer10038594
- Registration Number
- NL-OMON54112
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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 by Qiagen, 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.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective response rate (ORR) [Time Frame: Until disease progression, up to 36<br /><br>months]</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Outcome Measures :<br /><br>1. Incidence and severity of treatment emergent adverse events (TEAEs) [Time<br /><br>Frame: Up to 90 days after the last dose of study treatment]<br /><br>2. Incidence and severity of adverse events of special interest (AESIs) [Time<br /><br>Frame: Up to 90 days after the last dose of study treatment]<br /><br>3. Incidence and severity of serious adverse events (SAEs) [Time Frame: Up to<br /><br>90 days after the last dose of study treatment]<br /><br>4. Incidence and severity of >= grade 3 laboratory abnormalities [Time Frame: Up<br /><br>to 90 days after the last dose of study treatment]<br /><br>5. Duration of response (DOR) [Time Frame: Until disease progression, up to 36<br /><br>months]<br /><br>6. Progression free survival (PFS) [Time Frame: Until disease progression, up<br /><br>to 36 months]<br /><br>Overall survival (OS) [Time Frame: Up to 60 months]</p><br>