Description:
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).
The secondary objectives of the study are:
- To characterize the safety profile of cemiplimab + ISA101b
- To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of
response (DOR), progression-free survival (PFS), and overall survival (OS)
Title
- Brief Title: 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
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-ISA-1981
- SECONDARY ID:
2020-001239-29
- NCT ID:
NCT04646005
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Cemiplimab | REGN2810, Libtayo | Cemiplimab+ISA101b |
ISA101b | | Cemiplimab+ISA101b |
Purpose
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).
The secondary objectives of the study are:
- To characterize the safety profile of cemiplimab + ISA101b
- To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of
response (DOR), progression-free survival (PFS), and overall survival (OS)
Trial Arms
Name | Type | Description | Interventions |
---|
Cemiplimab+ISA101b | Experimental | | |
Eligibility Criteria
Key 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. Must have received prior bevacizumab and taxol unless meets pre-specified protocol
criteria
6. ECOG performance status of 0 or 1.
7. Has adequate organ and bone marrow function as defined in the protocol.
8. Anticipated life expectancy ≥20 weeks.
Key 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
NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | Until disease progression, up to 36 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence and severity of treatment emergent adverse events (TEAEs) |
Time Frame: | Up to 90 days after the last dose of study treatment |
Safety Issue: | |
Description: | |
Measure: | Incidence and severity of adverse events of special interest (AESIs) |
Time Frame: | Up to 90 days after the last dose of study treatment |
Safety Issue: | |
Description: | |
Measure: | Incidence and severity of serious adverse events (SAEs) |
Time Frame: | Up to 90 days after the last dose of study treatment |
Safety Issue: | |
Description: | |
Measure: | Incidence and severity of ≥ grade 3 laboratory abnormalities |
Time Frame: | Up to 90 days after the last dose of study treatment |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Until disease progression, up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) |
Time Frame: | Until disease progression, up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- HPV16 positive
- Squamous histology
- Recurrent
- Metastatic
Last Updated
July 9, 2021