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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04646005
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Administered intravenously (IV) every three weeks (Q3W)
  • ISA101b — BIOLOGICAL
    Administered by subcutaneous (SC) injection on day 1, day 29, and day 50

Study Details

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)

Key Dates

Start date
Jun 28, 2021
Status verified
Sep 2025
Primary completion
May 22, 2023
Completion
May 29, 2024

Study Design

Enrollment
113 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab+ISA101b

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From enrollment to last dose (~up to 23 months) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesTucsonArizona85704-
Arizona Oncology AssociatesTucsonArizona85711-
Regeneron Research SiteOrangeCalifornia92868-

Find similar trials in Tucson, AZ

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Arizona Oncology Associates· Tucson, AZRegeneron Research Site· Orange, CA

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