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Checkpoint Inhibitor
Pembrolizumab + Radiation for Cancer
Phase 2
Waitlist Available
Led By Harry Yoon
Research Sponsored by Hoosier Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 3, day 1 (each cycle is 21 days) (c3d1) until death or up to a maximum of 19 months
Awards & highlights
Study Summary
This trial is testing pembrolizumab, a type of immunotherapy, in combination with radiation therapy to see if it can help treat patients with cancer of unknown primary origin.
Who is the study for?
Adults with previously treated carcinoma of unknown primary, who have at least one measurable lesion and stable or progressive disease after prior therapy. They must not have had certain cancers, active infections, severe allergies to monoclonal antibodies, or recent major surgery. Participants need adequate organ function and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the combination of Pembrolizumab (an immunotherapy drug) with External Beam Radiation Therapy to see if it can boost the immune response against cancer cells in patients whose primary cancer site is unknown.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems like thyroid disorders, and infusion-related reactions. Radiation therapy might lead to fatigue, skin irritation at the treatment site, and potential damage to nearby organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from cycle 3, day 1 (each cycle is 21 days) (c3d1) until death or up to a maximum of 19 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 3, day 1 (each cycle is 21 days) (c3d1) until death or up to a maximum of 19 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abscopal Response Rate
Secondary outcome measures
Disease Control Rate
Evaluate Treatment-related Toxicity.
Explore the Association Between Response Rate (RR) and Other Endpoints (e.g., OS, PFS)
+4 moreSide 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: Single Arm AssignmentExperimental Treatment2 Interventions
Pembrolizumab + External Beam Radiation Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Find a Location
Who is running the clinical trial?
Hoosier Cancer Research NetworkLead Sponsor
68 Previous Clinical Trials
3,741 Total Patients Enrolled
14 Trials studying Carcinoma
1,088 Patients Enrolled for Carcinoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,680 Total Patients Enrolled
222 Trials studying Carcinoma
45,618 Patients Enrolled for Carcinoma
Harry YoonPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are physically able to perform daily activities and take care of yourself without assistance.You need to have a medical history and physical exam.You will need to have imaging tests of your chest, stomach, and pelvic area.You agree to give samples of your tissue and blood for research purposes.Women need to have a mammogram.You have other serious illnesses or medical conditions.The study will focus on evaluating areas where you have symptoms.You have had an organ or stem cell transplant in the past.You received radiation therapy on a part of your body that may cause harmful effects if you receive the study treatment.If you have liver metastasis or high levels of the protein called CEA, you may need to undergo a colonoscopy.You have another type of cancer that is currently being treated, which could affect the evaluation of the study's results.You must be 18 years or older to participate.You have given permission in writing to share your personal health information, including your medical history.You have a medical condition, received a treatment, or have a lab test result that could affect the accuracy of the trial.A sample of your previously collected tissue must be available and sent for testing before the study starts. If there is no available tissue, you may need to undergo a biopsy to collect new tissue for testing before the study starts.You have a history of mental health disorders or drug/alcohol abuse.The doctor will compare your current tumor with any previous tumors you had, if possible. This helps them determine the best treatment for you. They may also perform certain lab tests to help with the diagnosis. If you have a primary carcinoma, your treatment will be based on that and you will not be included in this study. The lab tests may not be needed if they were already performed earlier or if the doctor feels they are not necessary.You have a weakened immune system, or you have taken steroids or other drugs that suppress your immune system within the last week.You have tried at least one treatment for your cancer before, but it did not work or caused side effects that you could not tolerate.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm Assignment
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.
Is the opportunity currently available to join this clinical experiment?
"Recruiting has currently been suspended for this clinical trial, which was initially posted on February 1st 2018 and had its last update on the 16th of February 2022. If you're looking for other trials, there are 2469 studies involving carcinoma patients actively recruiting, as well as 961 that involve Pembrolizumab."
Answered by AI
To what ailments does Pembrolizumab provide relief?
"Pembrolizumab can be employed to treat malignant neoplasms, inoperable melanoma, and cases of microsatellite instability-high."
Answered by AI
How many participants have signed up for this medical research program?
"This medical study is no longer seeking participants. Its listing was initially published on February 1st 2018 and last edited on the 16th of February 2022. Presently, 2469 clinical trials for carcinoma are actively enrolling patients whereas 961 studies offer Pembrolizumab treatments with open recruitment slots."
Answered by AI
Has Pembrolizumab been accepted by the FDA's standards for use?
"Due to the fact that this Phase 2 trial has a moderate amount of data backing its safety but little proof pointing towards efficacy, our team at Power gave pembrolizumab a score of two."
Answered by AI
Have there been any prior experiments involving Pembrolizumab?
"At present, Pembrolizumab is being studied in 961 live trials with 122 of them reaching the Phase 3 stage. Research sites for this medication are widespread; there are 35727 locations conducting investigations on it, one of which is located in Houston, Texas."
Answered by AI
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