Hepatocellular CarcinomaPhase 2NCT06526104
Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis
A Phase 2 study testing Tremelimumab and Durvalumab in people with Hepatocellular Carcinoma and Cirrhosis, Liver, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cirrhosis, Liver
- What is being tested?
- Tremelimumab and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 1 Dec 2027
- 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
- Patients diagnosed with HCC based on pathologic diagnosis from biopsy or radiographic diagnosis on CT liver or MRI liver (i.e., Barcelona Clinic Liver Cancer (BCLC) stage B and not candidate for locoregional therapies or BCLC stage C)10
- Patients with Child-Pugh-B7 or -B8 liver cirrhosis11
- ECOG performance status score 0-1
- Patients with Hepatitis B Virus (HBV) infection are required to receive effective antiviral therapy and have a viral load less than 500 IU/mL at screening; antiviral therapy is not required for patients with Hepatitis C Virus (HCV) infection.
- Adequate organ and bone marrow function:
- Absolute neutrophil counts ≥1000/uL
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- Platelets ≥60 × 100/uL
- Hemoglobin ≥8.0 g/dL
- ALT and AST ≤5× upper limit of normal each
- Bilirubin ≤3 mg/dL,
- International normalized ratio (INR) ≤2.3 or prothrombin time ≤6 seconds above control)
- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- 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)
- Body weight >30 kilogram (kg)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Age >18 years at time of study entry or adult male or female (according to age of majority as defined as ≥18 years)
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Must have a life expectancy of at least 12 weeks.
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline.
Who cannot join
- Patients who are candidates for curative treatments
- History of uncontrolled hepatic encephalopathy in the past 6 months; patients who are stable on medical therapy are eligible.
- Active substance abuse or alcohol abuse at the time of consent or enrollment, which in the opinion of the treating physician would interfere with the safety of the patient and/or adherence to the study protocol.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Prior systemic therapy for locally advanced or metastatic HCC
- Participation in another clinical study with an investigational product during the last 1 month.
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- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. <<amend as required based on any combination studies with other anticancer agents>>
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- 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.
- History of allogenic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
- Patients with celiac disease controlled by diet alone.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab and tremelimumab combination therapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
- Known allergy or hypersensitivity to IP or any excipient.
- History of another primary malignancy except for:
- Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence.
- Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has undergone potentially curative therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Health San Antonio
San Antonio, Texas, 78229
Sukeshi Arora, MD, 210-450-2872, aroras@uthscsa.edu
About this study
Official title: Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis (STRIDE in CP-B)
This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.
Read the detailed description
Priming dose of tremelimumab 300 mg IV once (Cycle 1, Day 1 only) with durvalumab 1500 mg IV on Day 1 of each 4-week cycle. Patients will stay on study treatment until evidence of disease progression, unacceptable toxicity, or death.
All eligible patients who consent to this study must have a baseline evaluation (CT or MRI) within 28 days of the start of treatment.
Follow-up: A repeat CT/MRI scan will be performed after 2 cycles of treatment regimen to evaluate response based on RECIST 1.1 criteria (See Appendix for definitions of response).12 Serum tumor marker AFP (every cycle) and CT/MRI scans will be repeated at least every 2 cycles, or 8 weeks, to ensure no progression of disease. Patients will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent by the patient, or decision of physician for patient's best interest. Each patient will be followed for survival for up to one year.
- Conditions
- Hepatocellular Carcinoma, Cirrhosis, Liver
- Being tested
- Tremelimumab, Durvalumab
- Keywords
- Tremelimumab, Durvalumab, Child-Pugh-B Cirrhosis
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
Also called Imjudo
Priming dose of tremelimumab 300 mg IV once (Cycle 1, Day 1 only)
DurvalumabDrug
Also called Imfinzi
Durvalumab 1500 mg IV on Day 1 of each 4-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Stride (Single T Regular Interval D) Arm | Experimental | Tremelimumab dosed once at the beginning of the first cycle, 300mg IV infusion and Durvalumab 1500mg IV dosed with the first dose of Tremelimumab and then once per cycle (every 4 weeks) Receives: Drug: Tremelimumab; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs)
The number and grade 1-5 of all adverse events will be documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; measured at baseline, each cycle, and up to 90 days after treatment discontinued. Grade 3 and higher TRTE-AEs will be reported for this outcome.
Measured: Baseline up to 1 year
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR, complete and partial response, confirmed and unconfirmed as defined by Response evaluation criteria in solid tumors (RECIST) v1.1.9. ORR, complete and partial response, confirmed and unconfirmed) as defined by RECIST v1.1.9. RECIST version 1.1 RECIST is used as tumor response criteria in most trials of solid tumors in general. RECIST1. 1 uses unidimensional diameters of target lesions and the sum of measurements of all target lesions as a quantitative measure of tumor burden.
Measured: Baseline to 1 year
Progression Free Survival (PFS)
Measured from the date of registration until disease progression, symptomatic deterioration, or death.
Measured: Baseline to 1 year
Overall Survival (OS)
Measured from date of registration until death
Measured: Baseline to 1 year
Albumin-Bilirubin (ALBI) grade
Albumin-bilirubin (ALBI) grade is a tool that assesses liver function by combining serum albumin and bilirubin levels. It can be used to predict the prognosis of patients with liver cirrhosis and hepatocellular carcinoma, and has been shown to be more accurate than the Child-Pugh score. ALBI grade can also be used to predict survival for patients treated with radioembolization (RE), and as a prognostic indicator for cancer patients receiving chemotherapy. A calculator is used to generate the score. Based on the score, patients are graded between grade 1 (lowest mortality risk, ALBI score ≤2.60) and grade 3 the highest mortality risk (score >-1.39).
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start2 Dec 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (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 The University of Texas Health Science Center at San AntonioThe 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
- Model description
- This is a single-arm, phase II study of patients with advanced HCC with Child-Pugh B cirrhosis who are eligible for first-line treatment with T300+D.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Sukeshi Patel, The University of Texas Health Science Center at San Antonio
- Investigators
- Sukeshi Arora, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526104
- Sponsor's protocol ID
- CTMS# 23-0164
- Other IDs
- STUDY00001088
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial subjects) must be prepared in conjunction with the Mays DSMB, the trial's statistician, and verification that all study data to be used for the publication has been monitored for accuracy by the Mays QA team prior to publication or presentation.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis (STRIDE in CP-B)
- ClinicalTrials.gov ID
- NCT06526104
- Acronym / sponsor ID
- CTMS# 23-0164
- Conditions
- Hepatocellular Carcinoma, Cirrhosis, Liver
- Keywords
- Tremelimumab, Durvalumab, Child-Pugh-B Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Jul 2024 (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 a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.
Detailed description
Priming dose of tremelimumab 300 mg IV once (Cycle 1, Day 1 only) with durvalumab 1500 mg IV on Day 1 of each 4-week cycle. Patients will stay on study treatment until evidence of disease progression, unacceptable toxicity, or death.
All eligible patients who consent to this study must have a baseline evaluation (CT or MRI) within 28 days of the start of treatment.
Follow-up: A repeat CT/MRI scan will be performed after 2 cycles of treatment regimen to evaluate response based on RECIST 1.1 criteria (See Appendix for definitions of response).12 Serum tumor marker AFP (every cycle) and CT/MRI scans will be repeated at least every 2 cycles, or 8 weeks, to ensure no progression of disease. Patients will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent by the patient, or decision of physician for patient's best interest. Each patient will be followed for survival for up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, phase II study of patients with advanced HCC with Child-Pugh B cirrhosis who are eligible for first-line treatment with T300+D.
| Arm | Type | Receives |
|---|---|---|
| Stride (Single T Regular Interval D) Arm | Experimental | Drug: Tremelimumab, Drug: DurvalumabTremelimumab dosed once at the beginning of the first cycle, 300mg IV infusion and Durvalumab 1500mg IV dosed with the first dose of Tremelimumab and then once per cycle (every 4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients diagnosed with HCC based on pathologic diagnosis from biopsy or radiographic diagnosis on CT liver or MRI liver (i.e., Barcelona Clinic Liver Cancer (BCLC) stage B and not candidate for locoregional therapies or BCLC stage C)10
- Patients with Child-Pugh-B7 or -B8 liver cirrhosis11
- ECOG performance status score 0-1
- Patients with Hepatitis B Virus (HBV) infection are required to receive effective antiviral therapy and have a viral load less than 500 IU/mL at screening; antiviral therapy is not required for patients with Hepatitis C Virus (HCV) infection.
- Adequate organ and bone marrow function:
Key exclusion criteria (32 listed)
- Patients who are candidates for curative treatments
- History of uncontrolled hepatic encephalopathy in the past 6 months; patients who are stable on medical therapy are eligible.
- Active substance abuse or alcohol abuse at the time of consent or enrollment, which in the opinion of the treating physician would interfere with the safety of the patient and/or adherence to the study protocol.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Prior systemic therapy for locally advanced or metastatic HCC
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 |
|---|---|---|
| TremelimumabAlso: ImjudoPriming dose of tremelimumab 300 mg IV once (Cycle 1, Day 1 only) | Drug | Stride (Single T Regular Interval D) Arm |
| DurvalumabAlso: ImfinziDurvalumab 1500 mg IV on Day 1 of each 4-week cycle. | Drug | Stride (Single T Regular Interval D) Arm |
Primary outcome
Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs)
Time frame: Baseline up to 1 year
The number and grade 1-5 of all adverse events will be documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; measured at baseline, each cycle, and up to 90 days after treatment discontinued. Grade 3 and higher TRTE-AEs will be reported for this outcome.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to 1 year
Progression Free Survival (PFS)
Time frame: Baseline to 1 year
Overall Survival (OS)
Time frame: Baseline to 1 year
Albumin-Bilirubin (ALBI) grade
Time frame: Baseline to 1 year
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial subjects) must be prepared in conjunction with the Mays DSMB, the trial's statistician, and verification that all study data to be used for the publication has been monitored for accuracy by the Mays QA team prior to publication or presentation.
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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.
Sukeshi Arora, MD principal investigator
The University of Texas Health Science Center at San Antonio
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 and Durvalumab in people with Hepatocellular Carcinoma and Cirrhosis, Liver, run by The University of Texas Health Science Center at San Antonio 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 22 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 6 Jan 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?
Contact Epp Goodwin (210-450-5798, goodwine@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs) (time frame: Baseline up to 1 year). 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 6 Jan 2026.