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Monoclonal Antibodies
Immunotherapy for Early Stage Colon Cancer
Phase 2
Recruiting
Led By Daniel Catenacci, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a measurable primary lesion by lower endoscopy or CT-imaging with a diameter of 1 or more centimeters
Deemed to have surgically resectable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
Study Summary
This trial will study the effects of pembrolizumab on early stage colon cancer. The goal is to see if the immunotherapy drug can prevent the cancer from developing resistance.
Who is the study for?
Adults with early stage colon cancer that can be removed by surgery, who haven't had previous cancer treatments and have a tumor at least 1 cm in size. They must not be pregnant or breastfeeding, agree to use contraception, and have good organ function. People with active infections, other cancers needing treatment, immune diseases requiring recent therapy, or known allergies to pembrolizumab are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of pembrolizumab—an immunotherapy drug—on patients with early stage colon cancer before resistance develops. Participants will receive this medication alongside standard surgical procedures for their condition.See study design
What are the potential side effects?
Pembrolizumab may cause side effects like fatigue, skin reactions, diarrhea or constipation. It could also lead to more serious issues such as inflammation in organs like lungs (pneumonitis), liver problems or changes in how the immune system works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured and is at least 1 cm big.
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My doctor believes my cancer can be removed with surgery.
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My diagnosis is colon adenocarcinoma confirmed by tissue analysis.
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I agree to follow the study's rules for using contraception and not donate sperm for 120 days after my last treatment.
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My kidney function is adequate despite high creatinine levels.
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I have a confirmed tissue sample of my colon cancer available for testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My scans show no signs of cancer spread.
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I am 18 years old or older.
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I have not had chemotherapy, targeted therapy, or immunotherapy for colon cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To measure the feasibility of neoadjuvant pembrolizumab in early stage colon cancer
Secondary outcome measures
Measure the immune response in early stage colon cancer after neoadjuvant pembrolizumab
Measure the tumor response in early stage colon cancer after neoadjuvant pembrolizumab
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ARM A - Pembrolizumab + SurgeryExperimental Treatment2 Interventions
Group II: ARM B - SurgeryActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Surgery
2000
Completed Phase 3
~2550
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,731 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,100 Total Patients Enrolled
Daniel Catenacci, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
1,137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have an active tuberculosis infection.My kidney function is normal.My colon cancer has caused complications like fistulas, bleeding, or blockages.My cancer can be measured and is at least 1 cm big.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have fully recovered from any major surgery before starting treatment.My doctor believes my cancer can be removed with surgery.My organ functions are within normal ranges as required.I am currently being treated for an infection.My diagnosis is colon adenocarcinoma confirmed by tissue analysis.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am not pregnant, not breastfeeding, and meet one of the specific conditions listed.My organ functions are within normal ranges.I agree to follow the study's rules for using contraception and not donate sperm for 120 days after my last treatment.My kidney function is adequate despite high creatinine levels.I have a confirmed tissue sample of my colon cancer available for testing.My blood counts are within normal ranges.I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.I have been diagnosed with HIV.I have had pneumonitis treated with steroids or have it now.I have not received a live vaccine in the last 30 days.I have not taken steroids or immunosuppressants in the last 7 days.I am fully active or restricted in physically strenuous activity but can do light work.My scans show no signs of cancer spread.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I am 18 years old or older.I have not had chemotherapy, targeted therapy, or immunotherapy for colon cancer.My liver is functioning properly.I have active brain metastases or cancer in my brain's lining.
Research Study Groups:
This trial has the following groups:- Group 1: ARM A - Pembrolizumab + Surgery
- Group 2: ARM B - Surgery
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Could you please tell me what other scientific papers have been published that mention Pembrolizumab?
"Pembrolizumab is being researched in 122 Phase 3 trials, with a total of 1000 active clinical trials currently. The majority of these Houston-based studies are running out of Texas, but there are 36030 locations conducting Pembrolizumab research globally."
Answered by AI
How many people are being asked to participate in this clinical research?
"The listing on clinicaltrials.gov says that this research is still looking for patients to enroll. The study was first put up on May 20th, 2020 and the most recent edit was done on August 6th, 2021. They are aiming to have 46 people participate at 2 different locations."
Answered by AI
Are participants being accepted into the trial at this time?
"Yes, the latest information on clinicaltrials.gov suggests that this study is still searching for subjects. The listing was first posted on 5/20/2020 and edited as recently as 8/6/2021. They are looking for 46 individuals willing to participate across 2 locations."
Answered by AI
Are there long-term repercussions to prescription Pembrolizumab?
"Pembrolizumab is still being tested for efficacy in Phase 2 trials, so its safety score is a 2."
Answered by AI
What are some of the conditions that Pembrolizumab is used to treat?
"Pembrolizumab is a medication used to fight malignant neoplasms, but it can also be useful in treating other conditions such as unresectable melanoma and microsatellite instability high."
Answered by AI
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