A Phase 2 interventional study of Tremelimumab and Durvalumab in Hepatocellular Carcinoma, sponsored by MedImmune LLC. Active, not recruiting at 44 sites in 9 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 2, Interventional, and Treatment
This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
The study will comprise of 6 parts. Participants in Part 1A (safety run-in cohort), Part 1B (efficacy-gating cohort), Part 2A, and Part 4 will receive weight-based dosing regimens; and participants in Part 2B and Part 3 will receive fixed dosing regimens. Part 1A Stage 2 of the study may start after the first 3 participants in Stage 1 have been observed on study for at least 4 weeks. In addition, a separate cohort of participants will be enrolled in mainland China (China cohort) once global recruitment in Part 2A will be closed.
In Part 2A, participants will be randomized in a 1:1:1 ratio to receive:
In Part 3, participants will be randomized in a 2:2:1:2 ratio to receive:
Following protocol amendment 5, enrollment into 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg' arm will close. Participants will be randomized at a ratio of 2:1:2 in 'Durvalumab 1500 mg Q4W', 'Tremelimumab 750 mg Q4W for 7 doses followed by Q12W', and 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W' arms, respectively.
Participants will receive the treatment until confirm progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
All participants will be followed for survival until the end of study visit (last participant discontinues the study treatment).
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's enrollment of 433 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
First submitted after MedImmune LLC became part of AstraZeneca.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) will receive tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab · Biological: Durvalumab
Participants will receive durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Durvalumab
Participants will receive tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab · Biological: Durvalumab
Participants will receive tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab
Participants will receive tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first. Participant recruitment to this arm was closed following protocol amendment 5.
Biological: Tremelimumab · Biological: Durvalumab
Participants will receive durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first
Biological: Durvalumab · Biological: Bevacizumab
Participants will receive durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Durvalumab
Participants will receive tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab
Participants will receive tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab · Biological: Durvalumab
Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
Also known as: MEDI4736
Bevacizumab 15 mg/kg will be administered by IV infusion every 3 weeks until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any \>= Grade 2 pneumonitis that does not resolve to \<= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to \<= Grade 1 or baseline within 14 days, liver transaminase elevation \> 8 × upper limit of normal (ULN) or total bilirubin \> 5 × ULN, aspartate aminotransferase or alanine aminotransferase \> 3 × ULN with concurrent increase in total bilirubin \> 2 × ULN without evidence of cholestasis or alternative explanations, and any \>= Grade 3 non-irAE (except for the protocol stated conditions).
Time frame: From Day 1 to Day 28 after first dose of study drug
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters
Participants with clinically important Common Terminology Criteria for Adverse Events (CTCAE) grade changes to 3 or 4 in hematology and chemistry parameters are reported. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Vital sign assessment included pulse rate, blood pressure, temperature, weight, and respiratory rate. Vital signs abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
Number of participants with ECG abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)
Disease assessments based on investigator assessments and BICR review were determined by using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) guidelines. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Disease Control Rate (DCR) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The DCR is defined as a BOR of confirmed CR, confirmed PR, or stable disease (SD). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Time to Response (TTR) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTR is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Duration of Response (DoR) Based on Investigator Assessments and BICR
The DoR is defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments and BICR review by using RECIST v1.1 or death in absence of disease progression. A confirmed CR is defined in above outcome measures. The PD is defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. The DoR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Time to Progression (TTP) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTP was defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 to the first documentation of radiographic disease progression. However, if the participant died without tumor progression, they were censored at the time of death. Participants with no documented PD by the data cutoff date for TTP analysis were censored at the date of their last evaluable disease assessment. The TTP was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Progression Free Survival (PFS) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The PFS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of radiographic disease progression or death due to any cause, whichever occurs first. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared with the nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. Participants who were alive with no documented PD by the data cutoff date for PFS analysis were censored at the date of their last evaluable disease assessment. The PFS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Overall Survival (OS)
The OS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until death due to any cause. If there was no death reported for a participant by the data cut-off date for overall survival analysis, OS was censored at the last known alive date. The OS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Time frame: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
| Milestone | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Started | 40 | 104 | 75 | 69 | 84 | 47 | 3 | 5 | 6 |
| Treated | 40 | 101 | 74 | 69 | 82 | 47 | 3 | 5 | 5 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 40 | 104 | 75 | 69 | 84 | 47 | 3 | 5 | 6 |
| Withdrew: Death | 31 | 74 | 47 | 54 | 63 | 18 | 2 | 5 | 5 |
| Withdrew: Withdrawal by subject | 4 | 7 | 4 | 3 | 3 | 2 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 | 2 | 1 | 1 | 0 | 0 |
| Withdrew: Other | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Ongoing at the time of data cut-off date | 5 | 20 | 23 | 12 | 15 | 26 | 0 | 0 | 0 |
A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any \>= Grade 2 pneumonitis that does not resolve to \<= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to \<= Grade 1 or baseline within 14 days, liver transaminase elevation \> 8 × upper limit of normal (ULN) or total bilirubin \> 5 × ULN, aspartate aminotransferase or alanine aminotransferase \> 3 × ULN with concurrent increase in total bilirubin \> 2 × ULN without evidence of cholestasis or alternative explanations, and any \>= Grade 3 non-irAE (except for the protocol stated conditions).
| Participants | Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 0 |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measure at the time of end of study.
| Participants | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Any TEAEs | 38 | 95 | 73 | 67 | 80 | 45 | 3 | 5 | 5 |
| Any TESAEs | 22 | 45 | 32 | 36 | 37 | 17 | 1 | 3 | 4 |
Participants with clinically important Common Terminology Criteria for Adverse Events (CTCAE) grade changes to 3 or 4 in hematology and chemistry parameters are reported. There will be no updated results for this outcome measure at the time of end of study.
| Participants | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin | 0 | 5 | 6 | 6 | 6 | 0 | 0 | 1 | 1 |
| Leukocytes | 1 | 1 | 1 | 1 | 2 | 1 | 0 | 0 | 0 |
| Lymphocytes | 3 | 7 | 10 | 4 | 8 | 2 | 0 | 1 | 0 |
| Neutrophils | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Platelets | 3 | 5 | 0 | 2 | 4 | 3 | 1 | 0 | 0 |
| Activated Partial Thromboplastin Time | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Fibrinogen | 5 | 5 | 5 | 2 | 5 | 3 | 0 | 0 | 0 |
| Prothrombin Intl. Normalized Ratio | 0 | 1 | 3 | 1 | 0 | 1 | 0 | 0 | 0 |
| Alanine Aminotransferase | 3 | 7 | 13 | 5 | 10 | 1 | 0 | 0 | 0 |
| Albumin | 1 | 5 | 0 | 3 | 3 | 0 | 0 | 0 | 0 |
| Alkaline Phosphatase | 3 | 13 | 4 | 6 | 8 | 3 | 1 | 0 | 1 |
| Aspartate Aminotransferase | 5 | 25 | 19 | 16 | 17 | 4 | 0 | 1 | 1 |
| Bilirubin | 2 | 12 | 4 | 6 | 9 | 2 | 0 | 0 | 0 |
| Calcium - Hyper | 0 | 4 | 0 | 1 | 3 | 1 | 0 | 0 | 0 |
| Calcium - Hypo | 1 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Creatinine | 2 | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Glucose - Hyper | 4 | 8 | 14 | 6 | 5 | 2 | 0 | 0 | 0 |
| Glucose - Hypo | 2 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Magnesium - Hyper | 2 | 7 | 3 | 2 | 2 | 2 | 0 | 0 | 0 |
| Magnesium - Hypo | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Potassium - Hyper | 4 | 4 | 2 | 0 | 3 | 1 | 0 | 0 | 0 |
| Potassium - Hypo | 0 | 2 | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
| Sodium - Hyper | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sodium - Hypo | 9 | 12 | 7 | 13 | 11 | 6 | 0 | 0 | 1 |
Vital sign assessment included pulse rate, blood pressure, temperature, weight, and respiratory rate. Vital signs abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
| Participants | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | 1 | 4 | 4 | 2 | 3 | 6 | 0 | 0 | 0 |
| Hypotension | 0 | 4 | 0 | 3 | 2 | 0 | 0 | 0 | 0 |
| Systolic hypertension | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Weight decreased | 4 | 4 | 4 | 4 | 4 | 2 | 0 | 0 | 1 |
| Weight increased | 2 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 |
| Palpitations | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Pyrexia | 6 | 6 | 14 | 9 | 14 | 4 | 2 | 2 | 1 |
Number of participants with ECG abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
| Participants | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Acute myocardial infarction | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Angina pectoris | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 |
| Angina unstable | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Atrial fibrillation | 1 | 1 | 1 | 0 | 3 | 1 | 1 | 0 | 0 |
| Cardiac failure chronic | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cardiac failure congestive | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Coronary artery disease | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sinus bradycardia | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Tachycardia | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Atrioventricular block first degree | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cardiac arrest | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myocardial infarction | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Disease assessments based on investigator assessments and BICR review were determined by using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) guidelines. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. There will be no updated results for this outcome measure at the time of end of study.
| Percentage of participants | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| ORR based on BICR | — | 11.5 (6.1 to 19.3) | 24.0 (14.9 to 35.3) | 7.2 (2.4 to 16.1) | 9.5 (4.2 to 17.9) | 21.3 (10.7 to 35.7) | — | — | — |
| ORR based on Investigator assessments | 20.0 (9.1 to 35.6) | 11.5 (6.1 to 19.3) | 21.3 (12.7 to 32.3) | 8.7 (3.3 to 18.0) | 8.3 (3.4 to 16.4) | 34.0 (20.9 to 49.3) | 33.3 (0.8 to 90.6) | NA (NA to NA) | NA (NA to NA) |
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The DCR is defined as a BOR of confirmed CR, confirmed PR, or stable disease (SD). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. There will be no updated results for this outcome measure at the time of end of study.
| Percentage of participants | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| DCR based on BICR | — | 37.5 | 45.3 | 49.3 | 36.9 | 55.3 | — | — | — |
| DCR based on Investigator assessments | 60.0 | 45.2 | 50.7 | 47.8 | 34.5 | 63.8 | 33.3 | 20.0 | 16.7 |
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTR is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
| Months | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| TTR based on BICR | — | 3.65 (2.71 to 5.59) | 2.28 (1.81 to 3.68) | 1.81 (1.81 to 1.84) | 2.86 (1.84 to 3.83) | 2.10 (1.87 to 4.11) | — | — | — |
| TTR based on Investigator assessments | 2.68 (1.82 to 4.60) | 3.68 (1.81 to 5.55) | 1.86 (1.77 to 5.59) | 2.74 (1.81 to 5.32) | 3.88 (1.81 to 5.32) | 2.10 (1.94 to 4.12) | 5.55 (5.55 to 5.55) | — | — |
The DoR is defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments and BICR review by using RECIST v1.1 or death in absence of disease progression. A confirmed CR is defined in above outcome measures. The PD is defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. The DoR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
| Months | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| DoR based on BICR | — | 14.95 (8.54 to NA) | 18.43 (5.59 to 23.95) | 23.95 (4.07 to NA) | 13.21 (10.15 to NA) | NA (6.28 to NA) | — | — | — |
| DoR based on Investigator assessments | 16.66 (8.41 to NA) | NA (19.02 to NA) | 23.95 (5.59 to NA) | 27.53 (27.53 to NA) | 13.21 (12.85 to NA) | 10.51 (10.51 to NA) | 7.39 (7.39 to 7.39) | — | — |
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTP was defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 to the first documentation of radiographic disease progression. However, if the participant died without tumor progression, they were censored at the time of death. Participants with no documented PD by the data cutoff date for TTP analysis were censored at the date of their last evaluable disease assessment. The TTP was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
| Months | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| TTP based on BICR | — | 2.10 (1.87 to 3.52) | 3.71 (1.91 to 5.55) | 2.76 (1.87 to 5.42) | 1.87 (1.81 to 3.48) | 4.30 (2.10 to 6.24) | — | — | — |
| TTP based on Investigator assessments | 3.68 (2.23 to 6.77) | 3.38 (2.00 to 4.67) | 3.68 (2.07 to 5.52) | 2.60 (1.87 to 5.29) | 1.87 (1.77 to 3.48) | 7.46 (4.01 to NA) | 1.81 (1.64 to 12.91) | 3.75 (1.81 to 3.75) | 2.68 (1.84 to 3.48) |
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The PFS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of radiographic disease progression or death due to any cause, whichever occurs first. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared with the nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. Participants who were alive with no documented PD by the data cutoff date for PFS analysis were censored at the date of their last evaluable disease assessment. The PFS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
| Months | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| PFS based on BICR | — | 2.07 (1.84 to 2.86) | 2.17 (1.91 to 5.42) | 2.69 (1.87 to 5.29) | 1.87 (1.77 to 2.53) | 4.17 (2.10 to 6.24) | — | — | — |
| PFS based on Investigator assessments | 3.52 (1.87 to 5.29) | 2.40 (1.91 to 3.65) | 3.52 (2.07 to 5.42) | 2.60 (1.87 to 3.71) | 1.81 (1.77 to 2.40) | 6.24 (3.94 to 12.55) | 1.81 (1.64 to 12.91) | 2.20 (1.81 to 3.75) | 1.87 (0.66 to 3.48) |
The OS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until death due to any cause. If there was no death reported for a participant by the data cut-off date for overall survival analysis, OS was censored at the last known alive date. The OS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
| Months | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Overall Survival (OS) | 12.58 (6.87 to 20.99) | 12.91 (8.74 to 16.79) | 17.05 (10.55 to 22.83) | 17.05 (11.33 to 20.24) | 11.30 (8.38 to 14.95) | NA (12.52 to NA) | 30.69 (13.96 to NA) | 3.52 (2.20 to 20.96) | 6.28 (0.66 to 23.82) |
Collected over From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 31/40 (77.5%) | 22/40 (55%) | 37/40 (92.5%) |
| Parts 2 and 3: Durvalumab 1500 mg | 78/104 (75%) | 45/101 (44.6%) | 92/101 (91.1%) |
| Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | 49/75 (65.3%) | 32/74 (43.2%) | 73/74 (98.6%) |
| Parts 2 and 3: Tremelimumab 750 mg | 55/69 (79.7%) | 36/69 (52.2%) | 66/69 (95.7%) |
| Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | 64/84 (76.2%) | 37/82 (45.1%) | 80/82 (97.6%) |
| Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | 18/47 (38.3%) | 17/47 (36.2%) | 45/47 (95.7%) |
| China Cohort: Durvalumab 20 mg/kg | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| China Cohort: Tremelimumab 10 mg/kg | 5/5 (100%) | 3/5 (60%) | 5/5 (100%) |
| China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 5/6 (83.3%) | 4/5 (80%) | 5/5 (100%) |
| Event | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| AscitesGastrointestinal disorders | 2/40 | 3/101 | 0/74 | 0/69 | 2/82 | 2/47 | 0/3 | 0/5 | 2/5 |
| Hepatic function abnormalHepatobiliary disorders | 1/40 | 9/101 | 0/74 | 1/69 | 2/82 | 0/47 | 0/3 | 2/5 | 1/5 |
| Platelet count decreasedInvestigations | 0/40 | 0/101 | 0/74 | 0/69 | 0/82 | 0/47 | 1/3 | 0/5 | 0/5 |
| JaundiceHepatobiliary disorders | 0/40 | 0/101 | 0/74 | 1/69 | 0/82 | 0/47 | 0/3 | 0/5 | 1/5 |
| Upper respiratory tract infectionInfections and infestations | 0/40 | 0/101 | 1/74 | 0/69 | 0/82 | 0/47 | 0/3 | 1/5 | 0/5 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/40 | 0/101 | 0/74 | 0/69 | 1/82 | 0/47 | 0/3 | 1/5 | 0/5 |
| Haemorrhage intracranialNervous system disorders | 0/40 | 0/101 | 0/74 | 0/69 | 0/82 | 0/47 | 0/3 | 0/5 | 1/5 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/40 | 1/101 | 0/74 | 0/69 | 0/82 | 1/47 | 0/3 | 1/5 | 0/5 |
| DiarrhoeaGastrointestinal disorders | 0/40 | 3/101 | 2/74 | 6/69 | 0/82 | 0/47 | 0/3 | 0/5 | 0/5 |
| Oesophageal varices haemorrhageGastrointestinal disorders | 1/40 | 2/101 | 0/74 | 4/69 | 1/82 | 0/47 | 0/3 | 0/5 | 0/5 |
| Event | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 9/40 | 23/101 | 17/74 | 11/69 | 15/82 | 2/47 | 3/3 | 2/5 | 2/5 |
| Aspartate aminotransferase increasedInvestigations | 9/40 | 26/101 | 23/74 | 19/69 | 21/82 | 6/47 | 3/3 | 3/5 | 2/5 |
| HypothyroidismEndocrine disorders | 2/40 | 12/101 | 8/74 | 4/69 | 8/82 | 4/47 | 2/3 | 0/5 | 1/5 |
| PyrexiaGeneral disorders | 5/40 | 4/101 | 11/74 | 9/69 | 11/82 | 3/47 | 2/3 | 2/5 | 1/5 |
| Blood alkaline phosphatase increasedInvestigations | 3/40 | 11/101 | 7/74 | 7/69 | 6/82 | 0/47 | 2/3 | 1/5 | 1/5 |
| PruritusSkin and subcutaneous tissue disorders | 11/40 | 20/101 | 29/74 | 28/69 | 21/82 | 4/47 | 0/3 | 0/5 | 0/5 |
| AnaemiaBlood and lymphatic system disorders | 2/40 | 6/101 | 7/74 | 10/69 | 9/82 | 2/47 | 1/3 | 1/5 | 2/5 |
| Abdominal distensionGastrointestinal disorders | 3/40 | 10/101 | 8/74 | 6/69 | 5/82 | 3/47 | 1/3 | 2/5 | 1/5 |
| Abdominal pain upperGastrointestinal disorders | 2/40 | 5/101 | 3/74 | 6/69 | 3/82 | 2/47 | 0/3 | 1/5 | 2/5 |
| Bilirubin conjugated increasedInvestigations | 0/40 | 1/101 | 0/74 | 0/69 | 1/82 | 0/47 | 0/3 | 2/5 | 1/5 |
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1A, 1B, 2B, and 4), including participants who were randomized in error.
| Age, Customized(Participants) | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| < 65 years | 27 | 52 | 34 | 41 | 48 | 26 | 3 | 5 | 5 | 241 |
| >=65 to < 75 years | 8 | 33 | 31 | 18 | 26 | 13 | 0 | 0 | 1 | 130 |
| > 75 years | 5 | 19 | 10 | 10 | 10 | 8 | 0 | 0 | 0 | 62 |
| Sex: Female, Male(Participants) | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 10 | 12 | 10 | 12 | 14 | 6 | 1 | 0 | 0 | 65 |
| Male | 30 | 92 | 65 | 57 | 70 | 41 | 2 | 5 | 6 | 368 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 4 | 4 | 5 | 0 | 0 | 1 | 0 | 21 |
| Not Hispanic or Latino | 38 | 99 | 71 | 65 | 79 | 47 | 3 | 4 | 6 | 412 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Parts 2 and 3: Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | Parts 2 and 3: Tremelimumab 750 mg | Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | China Cohort: Durvalumab 20 mg/kg | China Cohort: Tremelimumab 10 mg/kg | China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 |
| Asian | 19 | 55 | 44 | 39 | 47 | 39 | 3 | 5 | 6 | 257 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 |
| Black or African American | 3 | 10 | 4 | 2 | 5 | 1 | 0 | 0 | 0 | 25 |
| White | 15 | 35 | 27 | 26 | 30 | 7 | 0 | 0 | 0 | 140 |
| More than one race | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Oct 2015 to primary completion in Nov 2020, 60 months.
Results were first posted in Dec 2021, 1 year 1 month after primary completion.
Of 80 industry-sponsored phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's 60 months is above that.
Counting every sponsor, half of 428 studies reached it within 43 months; a quarter within 30 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tremelimumab · Durvalumab