Study of Cemiplimab in Adults With Cervical Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03257267
Phase
PHASE3
Status
Completed

Conditions

  • Recurrent or Metastatic, Platinum-refractory Cervical Cancer
  • Squamous Cell Carcinoma (SCC)

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Intravenous (IV) administration every 3 weeks (Q3W)
  • Investigator Choice (IC) Chemotherapy — DRUG
    IC chemotherapy options include: 1. Antifolate: Pemetrexed 2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan 3. Nucleoside analogue: Gemcitabine 4. Vinca alkaloid: Vinorelbine The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.

Study Details

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Key Dates

Start date
Sep 5, 2017
Status verified
Apr 2025
Primary completion
Mar 15, 2021
Completion
Apr 20, 2023

Study Design

Enrollment
608 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Therapy
    Cemiplimab
  • Active Comparator: Control Therapy
    Investigator choice (IC) chemotherapy

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From first dose up to 90 following last dose (~42 months) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesPhoenixArizona85016-
Arizona Oncology AssociatesTucsonArizona85711-
University of California IrvineOrangeCalifornia92868-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Cancer Research for the OzarksSpringfieldMissouri65804-
New York Presbyterian QueensFlushingNew York11355-
Northwell HealthLake SuccessNew York11042-
Laura and Issac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
First Health of the Carolinas Outpatient Cancer CenterPinehurstNorth Carolina28374-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Texas Oncology, P.A.AustinTexas78745-

Find similar trials in Phoenix, AZ

By research site
Arizona Oncology Associates· Phoenix, AZArizona Oncology Associates· Tucson, AZUniversity of California Irvine· Orange, CAOchsner Clinic Foundation· New Orleans, LACancer Research for the Ozarks· Springfield, MONew York Presbyterian Queens· Flushing, NY

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