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New treatment option for Adenocarcinoma of the Colon
Official title NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer
ClinicalTrials.gov ID: NCT05197322
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenocarcinoma of the colon.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven adenocarcinoma of the colon or rectum which is MMR-d by IHC or MSI-H by PCR (or microsatellite testing if routine practice).
- Patient is fit (ECOG 0-1) and eligible for planned curative surgery in keeping with NICE guidelines and considered fit/suitable for adjuvant...
- Radiological node positive T1-4 CRC or
- Node negative high risk T3 defined as EITHER ≥ 5mm of extramural depth of invasion OR unequivocal EMVI on imaging (regardless of depth) or Node...
- Patients with rectal cancer are eligible if it is determined that neoadjuvant chemo-radiotherapy is not required to achieve a R0 resection.
You likely can't join if
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (M1)
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor...
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration. (NB: Participants must have recovered from...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to registration (seasonal flu vaccines that do not contain live virus are...
- Any investigational agents or investigational devices within 4 weeks prior to registration Note: Participants who have entered the follow-up phase of...
See the full eligibility criteria
Who can join
- Histologically proven adenocarcinoma of the colon or rectum which is MMR-d by IHC or MSI-H by PCR (or microsatellite testing if routine practice).
- Patient is fit (ECOG 0-1) and eligible for planned curative surgery in keeping with NICE guidelines and considered fit/suitable for adjuvant chemotherapy as per local site investigator's discretion based on:
- Radiological node positive T1-4 CRC or
- Node negative high risk T3 defined as EITHER ≥ 5mm of extramural depth of invasion OR unequivocal EMVI on imaging (regardless of depth) or Node negative T4 disease
- Patients with rectal cancer are eligible if it is determined that neoadjuvant chemo-radiotherapy is not required to achieve a R0 resection.
- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma/stent, and when recovered to a fitness level consistent with the other...
- Adequate bone marrow function:
- White Blood Cell \>3.0 x 10\^9/L;
- Absolute neutrophil count ≥1.5 x 10\^9/L
- Platelets ≥100 x 10\^9/L.
- Haemoglobin ≥90 g/L
- Adequate renal function: GFR \>50 mL/min estimated using validated creatinine clearance calculation (e.g. Cockroft-Gault) NB If the calculated creatinine clearance is \< 50 mL/min, a formal 24 hour urine collection or...
- Adequate liver function: Total bilirubin \ 1.5 × ULN AST and ALT ≤ 2.5 × ULN
- Adequate coagulation: International normalized ratio (INR) OR prothrombin time (PT) and Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT...
- Aged ≥18 years
- Able and willing to provide written informed consent
- Female patients of child bearing potential must be willing to use highly effective contraception for the duration of trial treatment and for 120 days after last dose of pembrolizumab
What rules you out
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (M1)
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration. (NB: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline, with the...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to registration (seasonal flu vaccines that do not contain live virus are permitted). Administration of killed vaccines is allowed
- Any investigational agents or investigational devices within 4 weeks prior to registration Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisolone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to the...
- Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or to any of its excipients.
- Has previous severe or life-threatening skin adverse reaction with other immune-stimulatory anticancer agents
- 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). NB: Replacement therapy (e.g...
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- Known history of Human Immunodeficiency Virus (HIV). NB: Testing for HIV for the NEOPRISM-CRC trial is not mandatory, however if this test has been done the result should be known prior to registration.
- Known active infection for hepatitis B (hepatitis B surface antigen [HbsAg] reactive) or known active hepatitis C (defined as hepatitis C virus [HCV] RNA [qualitative] is detected)
- Testing is required to determine eligibility. Hepatitis C antibody testing is allowed for initial screening purposes in sites where HCV RNA is not part of standard of care.
- Patients who are HbsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. Participants should remain on anti-viral therapy...
- Patients with history of HCV infection are eligible if HCV viral load is undetectable at screening and have completed anti-viral therapy at least 4 weeks prior to registration.
- Known history of active TB (Mycobacterium tuberculosis).
- Has had an allogenic tissue/solid organ transplant.
- Has peritonitis (secondary to perforated tumour)
- Has a colonic obstruction that has not been defunctioned or stented
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in...
- Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Female patients of child bearing potential who is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after...
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Glasgow, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Glasgow, United Kingdom; Leeds, United Kingdom; London, United Kingdom; Manchester, United Kingdom; Southampton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.