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Checkpoint Inhibitor

Cemiplimab for Colon Cancer

Phase 2
Recruiting
Led By Michael Overman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if cemiplimab can help people with dMMR colon cancer manage their disease.

Who is the study for?
Adults with localized colon cancer that is dMMR or MSI-H, confirmed by specific tests. They should have a certain level of physical fitness (ECOG 0-1), accessible tumors for endoscopic evaluation, and acceptable blood test results. Women of childbearing potential and men must agree to use contraception during the study and for some time after.
What is being tested?
The trial is testing Cemiplimab's effectiveness in controlling dMMR colon cancer without surgery. Participants will receive this immunotherapy drug to see if it can manage their cancer by enhancing their immune system's ability to fight tumor cells.
What are the potential side effects?
Cemiplimab may cause side effects such as fatigue, skin reactions, joint pain, diarrhea, and possibly immune-related conditions like inflammation in organs similar to autoimmune diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267
25%
Pyrexia
13%
Subcutaneous abscess
13%
Diarrhoea
13%
Hyperthyroidism
13%
Nausea
13%
Constipation
13%
Infusion related reaction
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy to Cemiplimab*
Cemiplimab
Chemotherapy*

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CemiplimabExperimental Treatment1 Intervention
Participants will receive cemiplimab by vein over about 30 minutes on Day 1 of each 3-week study cycle, up to 8 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,596 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
386,452 Total Patients Enrolled
Michael Overman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Cemiplimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05961709 — Phase 2
Colon Cancer Research Study Groups: Cemiplimab
Colon Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05961709 — Phase 2
Cemiplimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961709 — Phase 2
~33 spots leftby Apr 2026
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