Immunotherapy for Early Stage Colon Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Daniel Catenacci, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will gather information on the safety and effectiveness of pembrolizumab, an immunotherapy drug. The purpose of this study is to target early stage colon cancer before it has developed resistance to immunotherapy.

Eligibility Criteria

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.

Inclusion Criteria

My kidney function is normal.

My cancer can be measured and is at least 1 cm big.

My doctor believes my cancer can be removed with surgery.

Exclusion Criteria

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

I have an active tuberculosis infection.

Treatment Details

Interventions

• Pembrolizumab (Monoclonal Antibodies)
• Surgery (Surgery)

Trial Overview 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.

Participant Groups

Group I: ARM A - Pembrolizumab + Surgery Experimental Treatment 2 Interventions

Group II: ARM B - Surgery Active Control 1 Intervention

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

🇪🇺 Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

🇬🇧 Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Decatur Memorial Hospital Decatur, IL

University Of Chicago Medicine Comprehensive Cancer Center Chicago, IL

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

Merck Sharp & Dohme LLC Industry Sponsor

References