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PD-1 Inhibitor
Pembrolizumab + Dendritic Cell Therapy for Colorectal Cancer
Phase 2
Waitlist Available
Led By Sarbajit Mukherjee
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Recurrent and/or metastatic unresectable microsatellite stable (MSS) colorectal cancer
Must not have
Has an active infection requiring systemic therapy
Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection. Note: no testing for hepatitis B and hepatitis C is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Summary
This trial is testing whether pembrolizumab and dendritic cell-based treatment can shrink tumors in patients with colorectal cancer that has not responded to other treatments.
Who is the study for?
This trial is for adults with colorectal cancer that hasn't improved with standard treatments. They must have not used PD-1/PD-L1/PD-L2 inhibitors before, have at least two measurable tumors, and be in good physical condition (ECOG 0-1). Participants need functioning major organs and agree to use effective birth control. Those with severe allergies to pembrolizumab, active lung disease, ongoing immunosuppression, or recent other cancer treatments are excluded.
What is being tested?
The trial tests a combination of pembrolizumab (an immune checkpoint inhibitor) and dendritic cell-based therapy made from the patient's own blood cells. The goal is to see if this combo can shrink colorectal tumors by enhancing the body's immune response against cancer.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, fatigue, flu-like symptoms, skin reactions, digestive issues like diarrhea or constipation, and an increased risk of infections due to immune system activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My colorectal cancer cannot be removed by surgery and is not microsatellite unstable.
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I have at least 2 tumors that can be measured and one can be biopsied.
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My kidney function, measured by creatinine clearance, is sufficient.
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I am 18 years old or older.
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I have not received PD-1/PD-L1/PD-L2 treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for an infection.
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I have a known history of hepatitis B or active hepatitis C.
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I have an active autoimmune disease or a history of transplantation.
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I am on low-dose steroids or other immunosuppressants.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have been treated with drugs targeting immune checkpoints.
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I have or had lung inflammation that needed steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Incidence of toxicities and adverse events
Objective response rate
Overall survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, autologous dendritic cells)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV on days 8, 29, 50, and 71, and autologous dendritic cells intratumorally on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients may also receive an autologous dendritic cells intratumorally on day 50.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Therapeutic Autologous Dendritic Cells
2017
Completed Phase 2
~10
Pembrolizumab
2017
Completed Phase 2
~2070
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,398 Total Patients Enrolled
Sarbajit MukherjeePrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use effective birth control for two years after my last treatment.I am fully active or can carry out light work.I am currently being treated for an infection.You have had a very strong allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.I have an active autoimmune disease or a history of transplantation.I haven't had chemotherapy or radiotherapy in the last 2 weeks, and any side effects are mild.I have not responded to or cannot take certain standard cancer treatments.I have a known history of hepatitis B or active hepatitis C.I am on low-dose steroids or other immunosuppressants.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My colorectal cancer cannot be removed by surgery and is not microsatellite unstable.I have at least 2 tumors that can be measured and one can be biopsied.I agree to use contraception and not donate sperm for 1 year after my last treatment dose.I have stable brain metastases and haven't needed steroids for 14 days.My kidney function, measured by creatinine clearance, is sufficient.I am 18 years old or older.I agree to use effective birth control methods during and after the study for several years.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have been treated with drugs targeting immune checkpoints.You are currently taking part in another study testing a new drug or using a new medical device, or you have done so in the past 4 weeks.I have or had lung inflammation that needed steroids.I have not received PD-1/PD-L1/PD-L2 treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, autologous dendritic cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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