Hepatocellular CarcinomaEarly Phase 1NCT03099564
Pembrolizumab Plus Y90 Radioembolization in HCC Subjects
A Early Phase 1 study testing Pembrolizumab and Y90 radioembolization in people with Hepatocellular Carcinoma, run by Ashwin Somasundaram at 3 sites in United States.
Trial summary
This is an open-label multi-center trial designed to evaluate the efficacy as well as the safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with well compensated liver function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Pembrolizumab and Y90 radioembolization
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Mar 2017to Jun 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
- ECOG Performance Status of 0-1
- Locally advanced HCC as defined by: 1) tissue diagnosis OR 2) alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass on contrast-enhanced imaging OR 3) compatible mass on dual phase CT or dynamic contrast enhanced MRI demonstrating both arterial hypervascularity and delayed washout
- Hepatopulmonary shunting < 20% as documented via hepatic artery perfusion study
- No evidence of extrahepatic metastatic disease
Show all 28Show fewer
- Subjects must be considered poor prognosis by the following parameters: 1) right or left portal vein involvement (NOTE: subjects with main portal vein involvement are excluded), 2) multi-focal disease (more than 3 tumors regardless of size) AND/OR 3) diffuse disease considered amenable to liver directed therapy.
- Subjects with chronic infection by HCV who are untreated or who failed previous therapies for HCV are allowed on study. In addition, subjects with successful HCV treatment (defined as sustained virologic response [SVR] 12 or SVR 24) are allowed as long as patients are not actively receiving anti-HCV treatment at the time of study enrollment. Investigators can stop anti-HCV treatment at their discretion prior to enrolling patients on study. .
- If active HBV, viral load must be <100IU/mL; if active HBV, subjects must be on anti-viral medication for ≥ 3 months prior to study registration and remain on the same anti-viral regimen throughout study treatment. NOTE: those subjects who are positive for Hepatitis B core antibody (anti-HBc), negative for Hepatitis B surface antigen (HBsAg) and negative for Hepatitis B surface antibody (anti-HBs), and have an HBV viral load <100 IU/mL do not require HBV anti-viral prophylaxis.
- Not eligible for surgical resection or liver transplant or have refused such procedures.
- All disease must be amenable to embolization in one or two procedures
- Childs-Pugh Cirrhotic Status A or B with a maximum score of 7
- No evidence of clinically apparent ascites or active encephalopathy, and/or varices that have not been treated. Subjects with controlled ascites or encephalopathy are eligible so long as they meet Childs-Pugh score criterion. Please note that controlled ascites and encephalopathy require scores of 2 each when calculating the C-P score.
- No prior systemic therapy or radiotherapy (including Y90 radioembolization or cyberknife) for HCC. No prior TAE or TACE allowed. Previous liver resection and ablation therapy is permitted. Allowed prior therapies must be completed 4 weeks prior to the baseline scan, and untreated measurable disease (as per RECIST1.1) must be present.
- Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration:
- Hematological:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL; Platelet Count ≥ 60 x 10^9/L
- Renal:
- Calculated creatinine clearance ≥ 60 cc/min
- Hepatic:
- Bilirubin < 2.0 X ULN; Aspartate aminotransferase (AST) ≤ 5 × ULN; Alanine aminotransferase (ALT) ≤ 5 × ULN
- Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5
- Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to registration.
- Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation.
- Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
- Is willing to undergo a mandatory pre-treatment (all subjects) and post-treatment (10 subjects) research biopsy at the centers participating in research biopsies
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of study registration
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy (other than oral contraceptives) or any other form of immunosuppressive therapy within 7 days prior to registration.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency.) is not considered a form of systemic treatment.
- Known history of active TB
- Hypersensitivity to pembrolizumab or any of its excipients
Show all 22Show fewer
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to registration or who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to agents administered > 4 weeks prior
- Has had prior chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to registration, or who has not recovered (i.e., (i.e., ≤ Grade 1 or baseline)) from AEs due to previously administered agents
- If had major surgery, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to study registration
- Complete portal vein occlusion
- Vascular abnormalities or bleeding diathesis that indicates hepatic artery catheterization is contraindicated
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody
- Known history of HIV
- Untreated active HBV
- Dual infection with HBV/HCV or other hepatitis combinations at study entry
- Known history of, or any evidence of active, non-infectious pneumonitis
- History of organ or stem cell transplantation including previous history of liver transplantation
- Active infection requiring systemic therapy
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has history or current evidence of any condition, therapy or laboratory abnormality that may confound results or interfere with subject's participation in the trial.
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years.
- Has received a live vaccine within 30 days of planned start of study therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7097
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Washington/Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma With Preserved Liver Function. HCRN: GI15-225
This is an open-label multi-center trial designed to evaluate the efficacy as well as the safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with well compensated liver function. Treatment will consist of pembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization performed one week after the first dose of pembrolizumab. If bilobar disease is present, a second Y90 radioembolization will be performed no later than 4 weeks after the first procedure to the contralateral hepatic lobe.
Read the detailed description
If a second Y90 radioembolization treatment is required for bilobar disease, this should occur within 4 weeks of the initial procedure (between Cycles 2 and 3 of pembrolizumab). The next dose of pembrolizumab should be separated from the Y90 radioembolization by at least one week.
Imaging will be obtained every 9 weeks (after every 3 pembrolizumab treatment) to assess for tumor response and to evaluate for progression. Subjects will remain on treatment until documented tumor progression, unacceptable toxicity, study withdrawal or death.
Screening Angiography (shunt study):
During screening, subjects will undergo angiography using technetium-99-labeled macroaggregated albumin to detect any uptake outside the liver via measurement of hepatopulmonary shunting. Prior to the angiography, a local anesthetic (to numb the area prior to catheter insertion) and sedation will be administered to the subject, as per institutional standards.
This procedure is standard of care for subjects prior to Y90 radioembolization, and will be performed per institutional site standards. Hepatopulmonary shunting must be < 20% for subject to meet eligibility criteria. Subjects will undergo a mandatory tumor biopsy on the same day as the screening angiography.
Prior to administration of the first dose of pembrolizumab (i.e., Day 1 of Cycle 1), repeat laboratory tests will be obtained to ensure subject still meets eligibility criteria.
Pembrolizumab 200mg IV (IV over 30 minutes) every 3 weeks Day 1 per 21 day cycle (3 weeks).
Prior to administration of subsequent pembrolizumab doses, the following criteria must be met:
ALT and AST:
- Among subjects with baseline (screening) ALT/AST <2×ULN: ALT/AST < 5×ULN
- Among subjects with baseline (screening) ALT/AST ≥2×ULN: ALT/AST < 3× the baseline level
- ALT/AST ≤ 500 U/L regardless of baseline level
Total bilirubin:
- Among subjects with baseline levels < 1.5 mg/dL: a value of < 2.0 mg/dL
- Among subjects with baseline levels that are ≥ 1.5 mg/dL: a value < 2× the baseline level
- Total bilirubin ≤ 3.0 mg/dL regardless of baseline level
Y90 radioembolization will be performed as standard of care via institutional standards.
To be eligible for Y90 radioembolization, the following criteria must be met:
ALT and AST:
- Among subjects with baseline (screening) ALT/AST < 2×ULN: ALT/AST < 5×ULN
- Among subjects with baseline (screening) ALT/AST ≥ 2×ULN: ALT/AST < 3× the baseline level
- ALT/AST ≤ 500 U/L regardless of baseline level
Total bilirubin:
- Among subjects with baseline levels < 1.5 mg/dL: a value of < 2.0 mg/dL
- Among subjects with baseline levels that are ≥ 1.5 mg/dL: a value < 2× the baseline level
- Total bilirubin ≤ 3.0 mg/dL regardless of baseline level
In addition, any non-hepatic toxicities from the prior dose(s) of pembrolizumab must have resolved to Grade ≤ 2.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Pembrolizumab, Y90 radioembolization
- Keywords
- Pembrolizumab, Y90 Radioembolization, KEYTRUDA®, TheraSphere®, PD-1, IgG4/kappa isotype
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda®
pembrolizumab 200mg IV every three weeks
Y90 radioembolizationDevice
The first Y90 radioembolization treatment will be administered one week after the first dose of pembrolizumab. If a second Y90 radioembolization treatment is required for bilobar disease, this should occur within 4 weeks of the initial procedure (between Cycles 2 and 3 of pembrolizumab).
| Study group | Role | What they receive |
|---|---|---|
| pembrolizumab + Y90 radioembolization | Experimental | Pembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization (performed one week after the first dose of pembrolizumab) Receives: Drug: Pembrolizumab; Device: Y90 radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Freedom from progression or death at 6 months based on RECIST 1.1 criteria
Measured: 6 months
Secondary outcomes (4)
Assess Safety - toxicities as defined by the NCI CTCAE v4
Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4
Measured: 2 years
Time to progression (TTP)
Time from Day 1 (D1) of pembrolizumab to progression
Measured: 2 years
Objective response rate (ORR)
Per RECIST1.1 and mRECIST for Hepatocellular Carcinoma (HCC) and will be calculated as the number of subjects with a Complete Response (CR) or Partial Response (PR) divided by the total number of evaluable subjects
Measured: 2 years
Estimate overall survival (OS)
The time from Day 1 (D1) of pembrolizumab to death from any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start28 Mar 2017
- Primary completion19 May 2021
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashwin Somasundaram
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Ashwin Somasundaram, Hoosier Cancer Research Network
- Investigators
- Ashwin Somasundaram, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099564
- Sponsor's protocol ID
- HCRN GI15-225
- Status last verified
- Feb 2023
- First submitted
- 28 Mar 2017
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Yu S, Yu M, Keane B, Mauro DM, Helft PR, Harris WP, Sanoff HK, Johnson MS, O'Neil B, McRee AJ, Somasundaram A. A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma. Oncologist. 2024 Mar 4;29(3):270-e413. doi: 10.1093/oncolo/oyad331.
PubMed 38325328
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma With Preserved Liver Function. HCRN: GI15-225
- ClinicalTrials.gov ID
- NCT03099564
- Acronym / sponsor ID
- HCRN GI15-225
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Pembrolizumab, Y90 Radioembolization, KEYTRUDA®, TheraSphere®, PD-1, IgG4/kappa isotype
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ashwin SomasundaramUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label multi-center trial designed to evaluate the efficacy as well as the safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with well compensated liver function. Treatment will consist of pembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization performed one week after the first dose of pembrolizumab. If bilobar disease is present, a second Y90 radioembolization will be performed no later than 4 weeks after the first procedure to the contralateral hepatic lobe.
Detailed description
If a second Y90 radioembolization treatment is required for bilobar disease, this should occur within 4 weeks of the initial procedure (between Cycles 2 and 3 of pembrolizumab). The next dose of pembrolizumab should be separated from the Y90 radioembolization by at least one week.
Imaging will be obtained every 9 weeks (after every 3 pembrolizumab treatment) to assess for tumor response and to evaluate for progression. Subjects will remain on treatment until documented tumor progression, unacceptable toxicity, study withdrawal or death.
Screening Angiography (shunt study):
During screening, subjects will undergo angiography using technetium-99-labeled macroaggregated albumin to detect any uptake outside the liver via measurement of hepatopulmonary shunting. Prior to the angiography, a local anesthetic (to numb the area prior to catheter insertion) and sedation will be administered to the subject, as per institutional standards.
This procedure is standard of care for subjects prior to Y90 radioembolization, and will be performed per institutional site standards. Hepatopulmonary shunting must be < 20% for subject to meet eligibility criteria. Subjects will undergo a mandatory tumor biopsy on the same day as the screening angiography.
Prior to administration of the first dose of pembrolizumab (i.e., Day 1 of Cycle 1), repeat laboratory tests will be obtained to ensure subject still meets eligibility criteria.
Pembrolizumab 200mg IV (IV over 30 minutes) every 3 weeks Day 1 per 21 day cycle (3 weeks).
Prior to administration of subsequent pembrolizumab doses, the following criteria must be met:
ALT and AST:
- Among subjects with baseline (screening) ALT/AST <2×ULN: ALT/AST < 5×ULN
- Among subjects with baseline (screening) ALT/AST ≥2×ULN: ALT/AST < 3× the baseline level
- ALT/AST ≤ 500 U/L regardless of baseline level
Total bilirubin:
- Among subjects with baseline levels < 1.5 mg/dL: a value of < 2.0 mg/dL
- Among subjects with baseline levels that are ≥ 1.5 mg/dL: a value < 2× the baseline level
- Total bilirubin ≤ 3.0 mg/dL regardless of baseline level
Y90 radioembolization will be performed as standard of care via institutional standards.
To be eligible for Y90 radioembolization, the following criteria must be met:
ALT and AST:
- Among subjects with baseline (screening) ALT/AST < 2×ULN: ALT/AST < 5×ULN
- Among subjects with baseline (screening) ALT/AST ≥ 2×ULN: ALT/AST < 3× the baseline level
- ALT/AST ≤ 500 U/L regardless of baseline level
Total bilirubin:
- Among subjects with baseline levels < 1.5 mg/dL: a value of < 2.0 mg/dL
- Among subjects with baseline levels that are ≥ 1.5 mg/dL: a value < 2× the baseline level
- Total bilirubin ≤ 3.0 mg/dL regardless of baseline level
In addition, any non-hepatic toxicities from the prior dose(s) of pembrolizumab must have resolved to Grade ≤ 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pembrolizumab + Y90 radioembolization | Experimental | Drug: Pembrolizumab, Device: Y90 radioembolizationPembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization (performed one week after the first dose of pembrolizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
- ECOG Performance Status of 0-1
- Locally advanced HCC as defined by: 1) tissue diagnosis OR 2) alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass on contrast-enhanced imaging OR 3) compatible mass on dual phase CT or dynamic contrast enhanced MRI demonstrating both arterial hypervascularity and delayed washout
- Hepatopulmonary shunting < 20% as documented via hepatic artery perfusion study
Key exclusion criteria (22 listed)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of study registration
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy (other than oral contraceptives) or any other form of immunosuppressive therapy within 7 days prior to registration.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency.) is not considered a form of systemic treatment.
- Known history of active TB
- Hypersensitivity to pembrolizumab or any of its excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: Keytruda®pembrolizumab 200mg IV every three weeks | Drug | pembrolizumab + Y90 radioembolization |
| Y90 radioembolizationThe first Y90 radioembolization treatment will be administered one week after the first dose of pembrolizumab. If a second Y90 radioembolization treatment is required for bilobar disease, this should occur within 4 weeks of the initial procedure (between Cycles 2 and 3 of pembrolizumab). | Device | pembrolizumab + Y90 radioembolization |
Primary outcome
Progression free survival (PFS)
Time frame: 6 months
Freedom from progression or death at 6 months based on RECIST 1.1 criteria
4 secondary outcomes
Assess Safety - toxicities as defined by the NCI CTCAE v4
Time frame: 2 years
Time to progression (TTP)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Estimate overall survival (OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 38325328Yu S, Yu M, Keane B, Mauro DM, Helft PR, Harris WP, Sanoff HK, Johnson MS, O'Neil B, McRee AJ, Somasundaram A. A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma. Oncologist. 2024 Mar 4;29(3):270-e413. doi: 10.1093/oncolo/oyad331.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashwin Somasundaram, MD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pembrolizumab and Y90 radioembolization in people with Hepatocellular Carcinoma, run by Ashwin Somasundaram at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.