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Checkpoint Inhibitor
Cemiplimab for Colon Cancer
Phase 2
Waitlist Available
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 through study completion; an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
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
~1340
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,731 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,797 Total Patients Enrolled
Michael Overman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have not had any recent treatments within the specified timeframes.I am 18 years old or older.My primary tumor can be reached with an endoscope and I agree to have multiple endoscopic exams.I have recovered from previous cancer treatments, except for mild nerve issues or hair loss.I have other serious health conditions besides my cancer.I have known metastatic disease sites, an active autoimmune disease, or a history of pneumonitis.My colon cancer is localized and meets certain imaging criteria.I am not currently on any experimental drugs or standard treatments for colon cancer.My colon cancer has been confirmed by a specialized lab review.My colon cancer is identified as having high microsatellite instability or mismatch repair deficiency.I have had treatment for colon cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Cemiplimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are involved with utilizing Cemiplimab as a treatment option?
"Our team at Power gave Cemiplimab a score of 2 due to the Phase 2 nature of the trial, indicating that there is some clinical evidence backing its safety but no data yet supporting efficacy."
Answered by AI
Is enrollment in the clinical trial still underway?
"This trial, which was first published on January 31st 2024 and revised on July 18th 2023 is not currently recruiting. Nevertheless, there are 259 other trials actively seeking participants at this time."
Answered by AI
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