Pembrolizumab in Early Stage Colon Cancer

NCT04231526 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB19-1411
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• To measure the feasibility of neoadjuvant pembrolizumab in early stage colon cancer

  Measured using RECIST 1.1

  14 months

Secondary Outcomes (2)

• Measure the tumor response in early stage colon cancer after neoadjuvant pembrolizumab

  14 months

• Measure the immune response in early stage colon cancer after neoadjuvant pembrolizumab

  14 months

Study Arms (2)

ARM A - Pembrolizumab + Surgery

EXPERIMENTAL

Drug: Pembrolizumab; Procedure: Surgery

ARM B - Surgery

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

Pembrolizumab DRUG

2 cycles of neoadjuvant pembrolizumab (200mg IV every 21 days)

ARM A - Pembrolizumab + Surgery

Surgery PROCEDURE

Standard of care surgery

ARM A - Pembrolizumab + Surgery; ARM B - Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed colon adenocarcinoma.
• No prior chemotherapy, targeted therapy, or immunotherapy for colon cancer.
• Deemed to have surgically resectable disease.
• Archival tissue block containing colon adenocarcinoma must be confirmed available prior to enrollment. MSI testing should be obtained prior to starting therapy.
• Be willing and able to provide written informed consent/assent for the trial.
• Be 18 years of age or older on day of signing informed consent.
• Have a measurable primary lesion by lower endoscopy or CT-imaging with a diameter of 1 or more centimeters.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Have no histologically confirmed disseminated disease by CT or PET-CT staging.
• Male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 90 days after the last dose of study treatment.
• Demonstrate adequate organ function as defined below. All screening labs should be performed within 14 days of treatment initiation.
• Adequate Organ Function Laboratory Values

You may not qualify if:

• A WOCBP who has a positive urine pregnancy test during screening (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has a known history of active TB (Bacillus Tuberculosis)
• Known hypersensitivity to pembrolizumab or any of its excipients.
• If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

Sponsors & Collaborators

• University of Chicago: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

pembrolizumab; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Daniel Catenacci, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 18, 2020
• Study Start: May 20, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (2)