Cemiplimab for Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Carcinoma+3 More
Cemiplimab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is comparing two treatments for cervical cancer. The first treatment is cemiplimab and the second is chemotherapy. The goal is to see which treatment is better at overall survival, progression-free survival, objective response rate, duration of response, and quality of life.

Eligible Conditions
  • Carcinoma
  • Squamous cell carcinoma
  • Neoplasm Metastasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Time from randomization up to approximately 44 months

Month 40
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales
Month 40
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
Therapeutic procedure
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
Month 40
Overall Survival (OS)
Month 40
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Month 44
Overall survival (OS)
Month 40
Duration of Response (DOR) Assessed Per RECIST 1.1
Month 44
Duration of response (DOR)
Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Objective Response Rate (ORR)
Progression-free survival (PFS)
Quality of life (QOL)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control Therapy
1 of 2
Experimental Therapy
1 of 2

Active Control

Experimental Treatment

608 Total Participants · 2 Treatment Groups

Primary Treatment: Cemiplimab · No Placebo Group · Phase 3

Experimental Therapy
Drug
Experimental Group · 1 Intervention: Cemiplimab · Intervention Types: Drug
Control Therapy
Drug
ActiveComparator Group · 1 Intervention: Investigator Choice (IC) Chemotherapy · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from randomization up to approximately 44 months

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
543 Previous Clinical Trials
198,856 Total Patients Enrolled
23 Trials studying Carcinoma
4,232 Patients Enrolled for Carcinoma
SanofiIndustry Sponsor
2,031 Previous Clinical Trials
2,908,229 Total Patients Enrolled
42 Trials studying Carcinoma
5,219 Patients Enrolled for Carcinoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
223 Previous Clinical Trials
87,647 Total Patients Enrolled
12 Trials studying Carcinoma
2,819 Patients Enrolled for Carcinoma

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient must have a disease that can be measured using the RECIST 1.1 standard.
The text is saying that the people in the study had either received bevacizumab therapy before or had a documented reason why they couldn't receive it.
S The three acceptable histologies as defined in the protocol are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.
That is, they had either received paclitaxel therapy in the past, or they had a clinically documented reason why paclitaxel couldn't be given to them.
If your cervical cancer has come back after treatment with platinum therapy, there is a chance that it will progress or recur.
This means that the person has a very good performance status and is able to carry out all usual activities.
The patient requires adequate organ or bone marrow function for transplant.
This clinical trial has specific criteria that a patient must meet in order to participate
This patient has recurrent cervical cancer that is not curable with surgery or radiation therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.