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Monoclonal Antibodies
Pembrolizumab + Liver-Directed/PRRT for Liver Cancer
Phase 2
Waitlist Available
Research Sponsored by Nicholas Fidelman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be >= 18 years of age on day of signing informed consent
Have a histologically proven well-differentiated neuroendocrine tumor (WHO grade 1, grade 2, or morphologically and/or clinically well-differentiated grade 3) of any primary site, including unknown primary site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying pembrolizumab in combination with liver-directed therapy or peptide receptor radionuclide therapy to see how well they work compared with pembrolizumab alone in treating patients with well-differentiated neuroendocrine tumors that have spread to the liver.
Who is the study for?
This trial is for adults with well-differentiated neuroendocrine tumors that have spread to the liver. Participants must show tumor progression, have a life expectancy over 3 months, and adequate organ function. They should not be pregnant or breastfeeding and agree to use contraception. Exclusions include severe liver involvement by the tumor, active infections, certain medical treatments within specific timeframes before the trial starts, and known allergies to pembrolizumab.Check my eligibility
What is being tested?
The effectiveness of combining pembrolizumab (an immunotherapy drug) with either liver-directed therapies (like arterial embolization or radioembolization using Yttrium-90) or peptide receptor radionuclide therapy using 177Lu-DOTA0-Tyr3-Octreotate is being tested in patients with neuroendocrine tumors and liver metastases. The goal is to see if this combination works better than pembrolizumab alone.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. Liver-directed therapies can cause abdominal pain or changes in liver function tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a well-differentiated neuroendocrine tumor.
Select...
My tumor is grade 2 or 3, has a Ki-67 index over 10%, and shows somatostatin receptor expression.
Select...
My cancer has grown or spread in the last year.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My blood counts and organ functions are within the required ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment-related adverse events (Group 1)
Proportion of participants with an overall response
Secondary outcome measures
Duration of response (DOR)
Immune-related progression free survival (irPFS)
Median Progression free survival (PFS)
+1 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
3Treatment groups
Experimental Treatment
Group I: Group III [pembrolizumab, yttrium-90 microsphere RE] (CLOSED)Experimental Treatment2 Interventions
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have < 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.
Group II: Group II [pembrolizumab, TAE] (CLOSED)Experimental Treatment2 Interventions
Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have < 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.
Group III: Group I [pembrolizumab, 177Lu DOTATATE]Experimental Treatment2 Interventions
Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index > 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor < 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arterial Embolization
2016
Completed Phase 2
~10
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
BTG International Inc.OTHER
42 Previous Clinical Trials
3,054 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
Nicholas Fidelman, MDLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
42 Patients Enrolled for Neuroendocrine Tumors
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,521 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
2,160 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active, untreated Hepatitis B.I have not received a live vaccine within the last 30 days.I am using two birth control methods or am not having sex to join this study.I am 18 years old or older.I have a well-differentiated neuroendocrine tumor.My tumor is grade 2 or 3, has a Ki-67 index over 10%, and shows somatostatin receptor expression.My cancer has grown or spread in the last year.I am fully active or restricted in physically strenuous activity but can do light work.I have had peptide receptor radionuclide therapy before.I've had a procedure on my bile duct that affected the Ampulla of Vater or required a connection between my bile duct and intestines.More than 75% of my liver is affected by cancer.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have an active Tuberculosis infection.I am currently being treated for an infection.I haven't had any cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.I have cancer that has spread to my brain or spinal cord.I have liver fibrosis confirmed by tests or scans.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have been diagnosed with HIV.My blood counts and organ functions are within the required ranges.I have been treated for an autoimmune disease in the last 2 years.I have undergone treatments like thermal ablation or radiation within the last 30 days.I agree to use or continue using contraception or practice abstinence for 120 days after my last treatment dose.
Research Study Groups:
This trial has the following groups:- Group 1: Group I [pembrolizumab, 177Lu DOTATATE]
- Group 2: Group II [pembrolizumab, TAE] (CLOSED)
- Group 3: Group III [pembrolizumab, yttrium-90 microsphere RE] (CLOSED)
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.
What medical conditions are typically addressed with Pembrolizumab?
"Pembrolizumab can be employed to treat malignant neoplasms, unresectable melanoma, and those with a microsatellite instability high."
Answered by AI
What other research endeavors have included Pembrolizumab?
"Currently, there are 983 investigations of Pembrolizumab underway worldwide. Of those studies, 123 have reached the third stage of clinical trials. Most of these tests are being conducted in Houston, Texas; however, a total 35892 sites across the globe remain involved with research for this drug's efficacy."
Answered by AI
What objectives is this clinical experiment aiming to achieve?
"This study has two primary objectives. The first is to assess the best overall response rate (ORR) of pembrolizumab and PRRT in those with metastatic grade 3 WD-NETs at 12 weeks, taking into account RECIST 1.1 criteria. Furthermore, it will also measure the duration of response (DOR), immune-related progression free survival (irPFS), as well as any adverse events according to NCI Common Terminology for Adverse Events v5.0 using CTCAE toxicity grading systems over a 30 day period post treatment completion. Safety analysis will include tabulation of all toxicities"
Answered by AI
Are there any associated health risks with using Pembrolizumab?
"With a score of 2, pembrolizumab is considered relatively safe based on the available clinical data from Phase 2 trials. However, no efficacy has been established yet."
Answered by AI
How many participants are being administered this clinical trial's treatments?
"Confirmed. Clinicaltrials.gov displays information that this medical trial is still open for recruitment, having been posted on August 27th 2018 and most recently updated on December 17th 2021. 32 individuals are needed from only 1 site to complete the study's requirements."
Answered by AI
Are there any vacancies currently available for participation in this trial?
"The information on clinicaltrials.gov affirms that this trial is currently seeking participants. It was first listed on August 27th 2018 and the most recent edit occurred December 17th 2021."
Answered by AI
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