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Immunotherapy for Early Stage Colon Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: ARM A - Pembrolizumab + Surgery
- Group 2: ARM B - Surgery
- 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.
- 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
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."
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."
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."
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."
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."
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