- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231526
Pembrolizumab in Early Stage Colon Cancer
A Window of Opportunity Study of Pembrolizumab in Colon Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Daniel Catenacci, MD
- Phone Number: 773-702-2042
- Email: dcatenacci@medicine.bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Not yet recruiting
- University of Chicago Medicine Comprehensive Cancer Center
-
Principal Investigator:
- Daniel Catenacci, MD
-
Contact:
- Daniel Catenacci, MD
- Phone Number: 773-702-2042
- Email: dcatenacci@medicine.bsd.uchicago.edu
-
Decatur, Illinois, United States, 62526
- Recruiting
- Decatur Memorial Hospital
-
Contact:
- Casey Eaton
- Phone Number: 217-876-4758
- Email: eaton.casey@mhsil.com
-
Contact:
- Dianna Richardson
- Phone Number: 217-876-4760
- Email: richardson.dinna@mhsil.com
-
Principal Investigator:
- James Wade, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- Hematological
- Absolute neutrophil count (ANC) - ≥1500/µL
- Platelets - ≥100 000/µL
Hemoglobin - ≥7.0 g/dL or ≥5.6 mmol/La
- Renal
Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) - ≤1.5 × ULN OR
30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- Hepatic
- Total bilirubin - ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
AST (SGOT) and ALT (SGPT) - ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Coagulation
International normalized ratio (INR) OR prothrombin time (PT)/ Activated partial thromboplastin time (aPTT) - ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
- Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
Exclusion Criteria:
- 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).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has complications from colon cancer including but not limited to organ fistulas, bleeding and obstruction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARM A - Pembrolizumab + Surgery
|
2 cycles of neoadjuvant pembrolizumab (200mg IV every 21 days)
Standard of care surgery
|
Active Comparator: ARM B - Surgery
|
Standard of care surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the feasibility of neoadjuvant pembrolizumab in early stage colon cancer
Time Frame: 14 months
|
Measured using RECIST 1.1
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the tumor response in early stage colon cancer after neoadjuvant pembrolizumab
Time Frame: 14 months
|
Measured using RECIST 1.1
|
14 months
|
Measure the immune response in early stage colon cancer after neoadjuvant pembrolizumab
Time Frame: 14 months
|
Measured using RECIST 1.1
|
14 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Catenacci, MD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Pembrolizumab
Other Study ID Numbers
- IRB19-1411
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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