Hepatocellular CarcinomaPhase 2NCT03482102
Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
A Phase 2 study testing Tremelimumab, Durvalumab and Radiation in people with Hepatocellular Carcinoma and Biliary Tract Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer. The interventions involved in this study are: Durvalumab Tremelimumab Radiation Therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Biliary Tract Cancer
- What is being tested?
- Tremelimumab, Durvalumab and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 30 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically or cytologically confirmed hepatocellular carcinoma or biliary tract cancer
- Locally advanced/unresectable or metastatic disease
- Age ≥ 18 years at time of study entry
- ECOG Performance Status ≤ 1
- One previously unirradiated lesion amenable to 8 Gy x 3 radiotherapy based on dosimetric organ tolerance AND another unirradiated measurable lesion (per irRECIST) outside of the radiation field
- Immunotherapy-naïve
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- Progressed on, be intolerant of, or refused sorafenib [for HCC], second line treatment and beyond for cholangiocarcinoma or gemcitabine-based chemotherapy for biliary tract cancer
- The benefits of sorafenib have been discussed with the patient and the patient has refused treatment with sorafenib.
- Viral status (Hepatitis B and C) must be known. All HBV-positive patients must be on antiviral medication for viral suppression.
- Patients with concomitant HBV infection must have a confirmed diagnosis of HBV characterized by the presence of hepatitis B core antibodies, and be sufficiently suppressed with active antiviral treatment (per local institutional practice) prior to enrollment to ensure adequate viral suppression (HBV deoxyribonucleic acid [DNA] <2000 IU/mL).
- Patients with concomitant HCV infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA or anti-HCV antibody upon enrollment.
- Body weight ≥ 30 kg
- Child-Pugh Score of A. A score of B7 is allowed without severe ascites or without hepatic encephalopathy.
- Adequate organ and marrow function, defined as:
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1.5 x 10^9/L
- Platelet count ≥75×109/L
- Serum bilirubin ≤2.0× the upper limit of normal (ULN).
- ALT and AST ≤ 3 x institutional ULN
- Albumin > 2.8 g/dL
- INR < 2.0
- Calculated creatinine clearance > 40 mL/min as determined by Cockcroft-Gault (using actual body weight)
- Males:
- --Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Females:
- --Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Ability to understand and the willingness to sign a written informed consent document
- Female subjects must be either of non-reproductive potential (i.e., post-menopausal by history: ≥ 50 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations with follow up
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior irradiation to the planned radiation target lesion
- Prior immunotherapy including but not limited to anti-CTLA4, including tremelimumab anti-PD-1, and anti-PD-L1, including durvalumab
- Concurrent enrollment in another study unless it is an observational (e.g. non-interventional) study
- Received live attenuated vaccines within 30 days of first dose
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms using Fredericia's Correction
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- History of primary immunodeficiency
- History of solid organ transplantation
- Active or prior documented autoimmune disease within the past 2 years (NOTE: The following are exceptions to this criterion: Participants with vitiligo or alopecia; Participants with hypothyroidism (e.g. following Hashimoto syndrome) who are stable on hormone replacement; Participants with celiac disease controlled by diet alone: Participants with Grave's disease, or any chronic skin condition not requiring systemic treatment. Participants without active disease in the last 5 years may be included but only after consultation with the study physician.)
- Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- Prior other malignancy within 2 years (except for in situ disease, which is permissible)
- History of hypersensitivity to durvalumab, tremelimumab or any excipient
- History of (non-infectious) pneumonitis that required steroids; or evidence of interstitial lung disease or active, non-infectious pneumonitis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Current or prior use of immunosuppressive medication within 28 days before the first dose of treatment on this protocol, with the exceptions of
- Intranasal and inhaled corticosteroids
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- Premedication for hypersensitivity reactions (e.g. to CT contrast for scans)
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Subjects with uncontrolled seizures
- Female subjects who are pregnant or breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
- Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- --Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry or brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids and anti-convulsants for at least 14-28 days prior to start of study treatment). Following radiotherapy and/or surgery of the brain metastases patients must wait 4 weeks following the intervention to confirm stability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Official title: A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
This research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer.
The interventions involved in this study are:
- Durvalumab
- Tremelimumab
- Radiation Therapy
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses.
The FDA has not approved tremelimumab as a treatment for any disease.
Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system.
The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Being tested
- Tremelimumab, Durvalumab, Radiation
- Keywords
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
Tremelimumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
DurvalumabDrug
Also called Imfinzi
Durvalumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
RadiationRadiation
Radiation therapy is used to shrink cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Tremelimumab + Durvalumab + Radiation | Experimental | * Durvalumab via IV infusion every 28 days for up to 4 doses/cycles
* Tremelimumab via IV infusion every 28 days for up to 4 doses/cycles, and then continue durvalumab monotherapy every 4 weeks starting on Week 16 for up to 8 months.
* Radiation therapy will only be given during cycle 2 Receives: Drug: Tremelimumab; Drug: Durvalumab; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response rate
The number of participants that achieve either a complete response or partial response. Response rate (ORR) is assessed using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors). Response is evaluated with the use of computed tomography (CT) and magnetic resonance imaging (MRI) scans. Participants are evaluated for response for the duration of treatment.Treatment continues until disease progression, treatment is considered a safety risk, physicians decision, withdrawal from the study, or until the participant is lost to follow up. The best overall response recorded for each participant is reported.
- Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm (the sum may not be "0" if there are target nodes)
- Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Measured: Start of cycle 3, start of cycle 5, and then the start of every subsequent cycle for the remainder of treatment. One cycle is 4 weeks. (approximately 3 years)
Secondary outcomes (6)
Number of Participants With Treatment Related Adverse Events
The number of participants that experience treatment related adverse events as assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). Participants are evaluated for adverse events for the duration of treatment.Treatment continues until disease progression, treatment is considered a safety risk, physicians decision, withdrawal from the study, or until the participant is lost to follow up.
Measured: From the start of treatment until 30 days after the last dose of study drug is received (approximately 5 years)
Overall Survival
The median overall duration of survival as measured from the start of treatment until the time of death due to any cause or until the participant is lost to follow-up.
Measured: From the start of treatment until the time of death or loss to follow-up (approximately 7 years)
Disease Control Rate
The number of participants that achieve a complete response (CR), partial response (PR), or stable disease (SD) as their best overall response as evaluated using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors). Participants are evaluated for response for the duration of treatment. Treatment continues until disease progression, treatment is considered a safety risk, physicians decision, withdrawal from the study, or until the participant is lost to follow up.
- CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm (the sum may not be "0" if there are target nodes)
- PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
- SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study
Measured: Screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)
Progression Free Survival
The median amount of time from the start of treatment until the the first documentation of radiographic disease progression (per irRECIST) or death due to any cause, whichever occurs first. Participants who are alive with no documented disease progression by the data cutoff date for progression free survival analysis will be censored at the date of their last evaluable disease assessment.
- Prior Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions may be considered progression.)
Measured: From the start of treatment until the time of death or loss to follow-up, whichever occurs first (approximately 7 years)
Duration of Response
The median duration of time from first documentation of objective response to the first documented disease progression (per irRECIST). For participants who are alive and no documented progressive disease at the time of data cutoff for analysis, duration of response will be censored at the last evaluable disease assessment date.
Measured: From first documentation of response to treatment until the time of disease progression (approximately 2 years)
Time to Disease Progression
The median duration of time from the start of treatment to the first documentation of radiographic disease progression (perirRECIST). Participants with no documented progressive disease by the data cutoff date for time to progression analysis will be censored at the date of their last evaluable disease assessment.
Measured: From the start of treatment until the time of disease progression (approximately 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start14 May 2018
- Primary completion28 Feb 2024
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Julie Koenig, Massachusetts General Hospital
- Investigators
- Julie Koenig, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482102
- Sponsor's protocol ID
- 17-517
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2018
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT03482102
- Acronym / sponsor ID
- 17-517
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Keywords
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 14 May 2018 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 29 Mar 2018 (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 research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer.
The interventions involved in this study are:
- Durvalumab
- Tremelimumab
- Radiation Therapy
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses.
The FDA has not approved tremelimumab as a treatment for any disease.
Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system.
The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tremelimumab + Durvalumab + Radiation | Experimental | Drug: Tremelimumab, Drug: Durvalumab, Radiation: Radiation* Durvalumab via IV infusion every 28 days for up to 4 doses/cycles * Tremelimumab via IV infusion every 28 days for up to 4 doses/cycles, and then continue durvalumab monotherapy every 4 weeks starting on Week 16 for up to 8 months. * Radiation therapy will only be given during cycle 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Histologically or cytologically confirmed hepatocellular carcinoma or biliary tract cancer
- Locally advanced/unresectable or metastatic disease
- Age ≥ 18 years at time of study entry
- ECOG Performance Status ≤ 1
- One previously unirradiated lesion amenable to 8 Gy x 3 radiotherapy based on dosimetric organ tolerance AND another unirradiated measurable lesion (per irRECIST) outside of the radiation field
Key exclusion criteria (26 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior irradiation to the planned radiation target lesion
- Prior immunotherapy including but not limited to anti-CTLA4, including tremelimumab anti-PD-1, and anti-PD-L1, including durvalumab
- Concurrent enrollment in another study unless it is an observational (e.g. non-interventional) study
- Received live attenuated vaccines within 30 days of first dose
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 |
|---|---|---|
| TremelimumabTremelimumab target the cancerous proteins and stop the cancer cells from suppressing the immune system | Drug | Tremelimumab + Durvalumab + Radiation |
| DurvalumabAlso: ImfinziDurvalumab target the cancerous proteins and stop the cancer cells from suppressing the immune system | Drug | Tremelimumab + Durvalumab + Radiation |
| RadiationRadiation therapy is used to shrink cancer cells. | Radiation | Tremelimumab + Durvalumab + Radiation |
Primary outcome
Best Overall Response rate
Time frame: Start of cycle 3, start of cycle 5, and then the start of every subsequent cycle for the remainder of treatment. One cycle is 4 weeks. (approximately 3 years)
The number of participants that achieve either a complete response or partial response. Response rate (ORR) is assessed using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors). Response is evaluated with the use of computed tomography (CT) and magnetic resonance imaging (MRI) scans. Participants are evaluated for response for the duration of treatment.Treatment continues until disease progression, treatment is considered a safety risk, physicians decision, withdrawal from the study, or until the participant is lost to follow up. The best overall response recorded for each participant is reported. * Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm (the sum may not be "0" if there are target nodes) * Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
6 secondary outcomes
Number of Participants With Treatment Related Adverse Events
Time frame: From the start of treatment until 30 days after the last dose of study drug is received (approximately 5 years)
Overall Survival
Time frame: From the start of treatment until the time of death or loss to follow-up (approximately 7 years)
Disease Control Rate
Time frame: Screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)
Progression Free Survival
Time frame: From the start of treatment until the time of death or loss to follow-up, whichever occurs first (approximately 7 years)
Duration of Response
Time frame: From first documentation of response to treatment until the time of disease progression (approximately 2 years)
Time to Disease Progression
Time frame: From the start of treatment until the time of disease progression (approximately 7 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Julie Koenig, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tremelimumab, Durvalumab and Radiation in people with Hepatocellular Carcinoma and Biliary Tract Cancer, run by Massachusetts General Hospital at 1 site 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 29 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Best Overall Response rate (time frame: Start of cycle 3, start of cycle 5, and then the start of every subsequent cycle for the remainder of treatment. One cycle is 4 weeks. (approximately 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.