Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03257267
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2017-07-26
Brief Title:
Study of Cemiplimab in Adults With Cervical Cancer
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
An Open-Label Randomized Phase 3 Clinical Trial of REGN2810 Versus Investigators Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 investigators choice IC chemotherapy
The secondary objectives performed among SCC patients and among all eligible histologies SCC and adenocarcinomaadenosquamous 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 11
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
The secondary objectives performed among SCC patients and among all eligible histologies SCC and adenocarcinomaadenosquamous 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 11
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000350-19 | EUDRACT_NUMBER | None | None |