Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Pembrolizumab + Radiotherapy/Ablation for Colorectal Cancer
Phase 2
Waitlist Available
Led By Neil Segal, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Be ≥ 18 years of age on day of signing informed consent. Consent for tumor biopsies and blood draws for research purposes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that could improve the immune response to radiation therapy or ablation.
Who is the study for?
Adults with confirmed metastatic colorectal cancer who've had at least two standard treatments can join this trial. They must have a tumor that hasn't been treated with radiotherapy or ablation, be willing to use birth control, and have good organ function. People with brain metastases, active infections, certain health conditions or those pregnant cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of Pembrolizumab (an immunotherapy drug) combined with either radiotherapy or ablation in treating tumors not directly targeted by these therapies. It aims to see if this combination can boost the immune system's response against untreated tumors.See study design
What are the potential side effects?
Pembrolizumab may cause an overactive immune response leading to inflammation in various organs, fatigue, skin reactions, and flu-like symptoms. Radiotherapy might result in localized skin irritation and fatigue while ablation could cause discomfort at the treatment site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.
Select...
I am 18 or older and agree to provide samples for research.
Select...
My kidney function, measured by creatinine or GFR, is within the normal range.
Select...
My liver function tests are within the required limits.
Select...
My colorectal cancer diagnosis was confirmed through lab tests.
Select...
My colorectal cancer has spread or come back.
Select...
I have undergone at least two standard treatments, including those with oxaliplatin and irinotecan.
Select...
I have a tumor that needs radiation or ablation as standard care.
Select...
I have at least one tumor that can be measured and hasn't been treated with radiation or ablation.
Select...
I can fully care for myself and perform all my usual activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
response rate
Secondary outcome measures
Toxicity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab Plus RadiotherapyExperimental Treatment2 Interventions
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Group II: Pembrolizumab Plus AblationExperimental Treatment2 Interventions
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Radiotherapy
2017
Completed Phase 3
~2610
Radiofrequency ablation
2011
Completed Phase 4
~2290
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,588 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,519 Total Patients Enrolled
Neil Segal, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fully recovered from any major surgery before starting treatment.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or treated cervical cancer.I haven't needed strong medication for autoimmune disease in the last 3 months, except for minor conditions or stable hypothyroidism.I am 18 or older and agree to provide samples for research.I agree to let researchers use my stored tissue samples.My recent tests show my organs are functioning well.My kidney function, measured by creatinine or GFR, is within the normal range.My liver function tests are within the required limits.I am currently being treated for an infection.I have been treated with specific immune-targeting drugs before.I have not received a live vaccine in the last 30 days.I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.I haven't had chemotherapy or targeted therapy in the last 2 weeks and have recovered from previous treatment side effects, except for mild neuropathy.My brain metastases are stable, and I haven't used steroids in the last 7 days.I have a lung condition not caused by an infection.My colorectal cancer diagnosis was confirmed through lab tests.My colorectal cancer has spread or come back.I have undergone at least two standard treatments, including those with oxaliplatin and irinotecan.I have a tumor that needs radiation or ablation as standard care.I have at least one tumor that can be measured and hasn't been treated with radiation or ablation.I am a woman who can have children and have a negative pregnancy test before starting treatment.I agree to use birth control during and for 4 months after the study treatment.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I have been diagnosed with HIV.I can fully care for myself and perform all my usual activities.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab Plus Ablation
- Group 2: Pembrolizumab Plus Radiotherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other investigations that have focused on Radiotherapy treatments?
"At the moment, 961 Radiotherapy studies are underway with 122 in Phase 3. Though most trials for this therapy happen near Houston, Texas; globally a full 35731 centres are conducting related research."
Answered by AI
What are the common disorders treated with Radiotherapy?
"Radiotherapy is a viable treatment for malignant neoplasms, microsatellite instability high, and unresectable melanoma."
Answered by AI
What is the aggregate amount of participants involved in this clinical trial?
"This investigation has unfortunately completed its recruitment phase. Initially advertised on April 1st, 2015 and last edited on the 6th of April 2022, this trial is no longer taking partakers. There are currently 876 studies involving colorectal cancer and 961 trials related to Radiotherapy that remain open for volunteer enrolment."
Answered by AI
How perilous is exposure to Radiotherapy for individuals?
"Radiotherapy has been judged to be a 2 on the safety scale, since Phase 2 trials have provided evidence of its security but no proof that it is effective."
Answered by AI
Are there any current opportunities to participate in this research?
"Currently, this clinical trial is not recruiting patients. Initially posted on April 1st 2015 and the last edit occured in early April of 2022. Nonetheless, there are presently 1837 trials which need volunteers to participate."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger