Colon CancerPhase 2NCT04231526
Pembrolizumab in Early Stage Colon Cancer
A Phase 2 study testing Pembrolizumab and Surgery in people with Colon Cancer, run by University of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Pembrolizumab and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2020to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Decatur Memorial Hospital
Decatur, Illinois, 62526
About this study
Official title: A Window of Opportunity Study of Pembrolizumab in Colon Cancer
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
- Being tested
- Pembrolizumab, Surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
2 cycles of neoadjuvant pembrolizumab (200mg IV every 21 days)
SurgeryProcedure or surgery
Standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| ARM A - Pembrolizumab + Surgery | Experimental | Not described Receives: Drug: Pembrolizumab; Procedure: Surgery |
| ARM B - Surgery | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the feasibility of neoadjuvant pembrolizumab in early stage colon cancer
Measured using RECIST 1.1
Measured: 14 months
Secondary outcomes (2)
Measure the tumor response in early stage colon cancer after neoadjuvant pembrolizumab
Measured using RECIST 1.1
Measured: 14 months
Measure the immune response in early stage colon cancer after neoadjuvant pembrolizumab
Measured using RECIST 1.1
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 May 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: unable to accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Daniel Catenacci, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231526
- Sponsor's protocol ID
- IRB19-1411
- Status last verified
- Jul 2024
- First submitted
- 20 Dec 2019
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window of Opportunity Study of Pembrolizumab in Colon Cancer
- ClinicalTrials.gov ID
- NCT04231526
- Acronym / sponsor ID
- IRB19-1411
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to accrue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A - Pembrolizumab + Surgery | Experimental | Drug: Pembrolizumab, Procedure: Surgery |
| ARM B - Surgery | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab2 cycles of neoadjuvant pembrolizumab (200mg IV every 21 days) | Drug | ARM A - Pembrolizumab + Surgery |
| SurgeryStandard of care surgery | Procedure or surgery | ARM A - Pembrolizumab + Surgery, ARM B - Surgery |
Primary outcome
To measure the feasibility of neoadjuvant pembrolizumab in early stage colon cancer
Time frame: 14 months
Measured using RECIST 1.1
2 secondary outcomes
Measure the tumor response in early stage colon cancer after neoadjuvant pembrolizumab
Time frame: 14 months
Measure the immune response in early stage colon cancer after neoadjuvant pembrolizumab
Time frame: 14 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Catenacci, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Surgery in people with Colon Cancer, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the feasibility of neoadjuvant pembrolizumab in early stage colon cancer (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.