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Monoclonal Antibodies
Pembrolizumab for Small Intestinal Cancer
Phase 2
Waitlist Available
Led By Robert McWilliams
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential must have a negative pregnancy test and agree to use birth control methods or abstain from heterosexual activity during the study and for 120 days after the last dose of study medication
Must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year (up to 18 cycles)
Awards & highlights
Study Summary
This trial will test how well pembrolizumab works on patients with small bowel adenocarcinoma that has spread or can't be removed by surgery.
Who is the study for?
This trial is for patients with small bowel adenocarcinoma that has spread or can't be surgically removed. Participants must have had prior chemotherapy, adequate organ function, and no recent use of other investigational drugs. They should not have autoimmune diseases, active infections, or a history of certain cancers.Check my eligibility
What is being tested?
The effectiveness of pembrolizumab, a monoclonal antibody designed to block cancer growth by interfering with tumor cells' ability to evade the immune system. This phase II trial will assess its impact on advanced small bowel adenocarcinoma.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, will use birth control, or abstain from sex during and for 120 days after the study.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is in the small bowel and cannot be removed or has spread.
Select...
My liver and kidney tests are within the required ranges.
Select...
My cancer is a type of small bowel adenocarcinoma, not related to the ampulla of Vater or appendix.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year (up to 18 cycles)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year (up to 18 cycles)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Confirmed Response Rate
Secondary outcome measures
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution
Overall Survival
Progression Free Survival
Other outcome measures
Tumor Markers
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,626 Total Patients Enrolled
2 Trials studying Small Intestinal Adenocarcinoma
848 Patients Enrolled for Small Intestinal Adenocarcinoma
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,095 Total Patients Enrolled
Robert McWilliamsPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the small bowel and cannot be removed or has spread.My cancer started in the ampulla or appendix.I have an immune system disorder or have been on steroids or immune-suppressing drugs in the last week.I have recently used specific therapies or treatments.I have another cancer that is getting worse or needs treatment.I don't have any health issues that could affect the trial's outcome.I have not received a live vaccine in the last 30 days.I am fully active or restricted in physically strenuous activity but can do light work.I have or had lung inflammation not caused by an infection.I am not pregnant, will use birth control, or abstain from sex during and for 120 days after the study.You are willing to provide blood and tissue samples for research purposes.My cancer is in the small bowel and cannot be removed or has spread.My cancer is not adenocarcinoma.My liver and kidney tests are within the required ranges.I have a history of HIV or active hepatitis B or C.I have had active tuberculosis in the past.I am currently on medication for an infection.I have been treated with specific immune system boosting drugs before.I've had chemotherapy for cancer that has spread, but not just as a preventive measure.My cancer is a type of small bowel adenocarcinoma, not related to the ampulla of Vater or appendix.I have cancer that has spread to my brain or spinal cord.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active 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 current studies in the US that involve this intervention?
"At present, 8 medical centres are actively enrolling participants for this clinical trial. Locations include Rapid City, Houston and Buffalo among other cities. To reduce travel costs, it is suggested that you choose the nearest location to your residence if you decide to participate in this study."
Answered by AI
What diseases does Pembrolizumab have the most success in combating?
"Pembrolizumab is a therapeutic option for treating malignant neoplasms, as well as unresectable melanoma, microsatellite instability high conditions and chemotherapy-induced progression."
Answered by AI
To what extent has Pembrolizumab been explored in prior research?
"Initially, pembrolizumab was studied at City of Hope during 2010. Over 800 trials have since been completed and currently there are nearly 1,000 active clinical studies occurring in Rapid City and the surrounding area."
Answered by AI
How many individuals are currently enrolled in this scientific experiment?
"As of June 13th 2022, this particular trial is not actively seeking participants. It was first posted on March 24th 2017 and has since been updated multiple times. For those looking for other medical trials, there are 3111 studies recruiting patients with metastatic small intestinal adenocarcinoma and 961 clinical trials involving pembrolizumab that require volunteers."
Answered by AI
To what extent might Pembrolizumab be a risk to human health?
"Due to the limited success of Phase 2 trials, our team at Power has rated the safety profile of Pembrolizumab a 2. Thus far, there is some evidence that suggests it may be safe for use but no data supporting its efficacy."
Answered by AI
Are any vacancies available for prospective participants in this clinical trial?
"This clinical trial has already completed its recruitment process. First posted on March 24th of 2017, it was last updated on June 13th 2022. Should you be searching for suitable medical studies, there are currently 3111 trials actively recruiting patients with metastatic small intestinal adenocarcinoma and 961 trials that involve pembrolizumab."
Answered by AI
Who else is applying?
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I've tried 3 other drugs that have not worked, and now I am hoping this clinical trial will help address my medical condition.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long does the trial go for? How long is the screening process? How long is the clinical trial?
PatientReceived no prior treatments
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