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A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Subjects With Advanced Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02519348
Enrollment
433
Registered
2015-08-10
Start date
2015-10-19
Completion date
2026-12-18
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Immunotherapy, Antibodies, Monoclonal, Tremelimumab, MEDI4736, Durvalumab

Brief summary

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.

Detailed description

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 1 (both 1A and 1B), participants will receive tremelimumab 1 mg/kg intravenous (IV) every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W. * In Part 2A, participants will be randomized in a 1:1:1 ratio to receive: * Durvalumab 20 mg/kg Q4W * Tremelimumab 10 mg/kg Q4W × 7 doses followed by every 12 weeks (Q12W) * Tremelimumab 1 mg/kg Q4W × 4 doses + durvalumab 20 mg/kg Q4W, followed by durvalumab 20 mg/kg Q4W * In China cohort, Part 2A study design will be followed. * In Part 2B, participants will receive tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W. * In Part 3, participants will be randomized in a 2:2:1:2 ratio to receive: * Durvalumab 1500 mg Q4W * Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W * Tremelimumab 750 mg Q4W for 7 doses followed by Q12W * Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W, followed by durvalumab 1500 mg Q4W. 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. • In Part 4, participants will receive durvalumab 1120 mg (15 mg/kg) + bevacizumab 15 mg/kg every 3 weeks (Q3W). 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).

Interventions

BIOLOGICALTremelimumab

Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.

BIOLOGICALDurvalumab

Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.

BIOLOGICALBevacizumab

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.

Sponsors

MedImmune LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

1. Male or female participants 2. 18 years and older (Japan-20 years and older) 3. Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods. 4. Immunotherapy-naïve 5. Have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved TKI. For arm 5 only: Have not received any prior systemic therapy for HCC.

Exclusion criteria

1. Prior exposure to immune-mediated therapy 2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy 3. Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months 4. Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. 5. Main portal vein thrombosis (Vp4) as documented on imaging 6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment 7. Active or prior documented autoimmune or inflammatory disease with some exceptions 8. Current or prior use of immunosuppressive medication within 14 days with some exceptions

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Dose Limiting Toxicities (DLTs)From Day 1 to Day 28 after first dose of study drugA 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).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)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)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.
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFrom 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)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.
Number of Participants With Abnormal Vital Signs Reported as TEAEsFrom 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)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.
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsFrom 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 ECG abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.

Secondary

MeasureTime frameDescription
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)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 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.
Disease Control Rate (DCR) Based on Investigator Assessments and BICRFrom 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 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 to Response (TTR) Based on Investigator Assessments and BICRFrom 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 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.
Duration of Response (DoR) Based on Investigator Assessments and BICRFrom 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)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 to Progression (TTP) Based on Investigator Assessments and BICRFrom 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 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.
Progression Free Survival (PFS) Based on Investigator Assessments and BICRFrom 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 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.
Overall Survival (OS)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)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.

Countries

China, Hong Kong, Italy, Japan, Singapore, South Korea, Spain, Taiwan, United States

Contacts

STUDY_DIRECTORMedImmune, LLC MedImmune, LLC

MedImmune LLC

Participant flow

Pre-assignment details

The results data are reported per the primary completion date (data cut-off date of 06Nov2020).

Participants by arm

ArmCount
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received 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 occurred first.
40
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
104
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received 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 occurred first.
75
Parts 2 and 3: Tremelimumab 750 mg
Participants received 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 occurred first.
69
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received 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 occurred first.
84
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received 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 occurred first.
47
China Cohort: Durvalumab 20 mg/kg
Participants received 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 occurred first.
3
China Cohort: Tremelimumab 10 mg/kg
Participants received 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 occurred first.
5
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received 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 occurred first.
6
Total433

Baseline characteristics

CharacteristicTotalPart 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgParts 2 and 3: Durvalumab 1500 mgParts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgParts 2 and 3: Tremelimumab 750 mgParts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgPart 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgChina Cohort: Durvalumab 20 mg/kgChina Cohort: Tremelimumab 10 mg/kgChina Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Age, Customized
>=65 to < 75 years
130 Participants8 Participants33 Participants31 Participants18 Participants26 Participants13 Participants0 Participants0 Participants1 Participants
Age, Customized
< 65 years
241 Participants27 Participants52 Participants34 Participants41 Participants48 Participants26 Participants3 Participants5 Participants5 Participants
Age, Customized
> 75 years
62 Participants5 Participants19 Participants10 Participants10 Participants10 Participants8 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants2 Participants5 Participants4 Participants4 Participants5 Participants0 Participants0 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
412 Participants38 Participants99 Participants71 Participants65 Participants79 Participants47 Participants3 Participants4 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants1 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
257 Participants19 Participants55 Participants44 Participants39 Participants47 Participants39 Participants3 Participants5 Participants6 Participants
Race (NIH/OMB)
Black or African American
25 Participants3 Participants10 Participants4 Participants2 Participants5 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants0 Participants2 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants1 Participants1 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
140 Participants15 Participants35 Participants27 Participants26 Participants30 Participants7 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
65 Participants10 Participants12 Participants10 Participants12 Participants14 Participants6 Participants1 Participants0 Participants0 Participants
Sex: Female, Male
Male
368 Participants30 Participants92 Participants65 Participants57 Participants70 Participants41 Participants2 Participants5 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
31 / 4078 / 10449 / 7555 / 6964 / 8418 / 472 / 35 / 55 / 6
other
Total, other adverse events
37 / 4092 / 10173 / 7466 / 6980 / 8245 / 473 / 35 / 55 / 5
serious
Total, serious adverse events
22 / 4045 / 10132 / 7436 / 6937 / 8217 / 471 / 33 / 54 / 5

Outcome results

Primary

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)

Population: Safety analysis set included all participants who received at least one dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased2 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia6 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased4 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased4 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension4 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia6 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension4 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia14 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased4 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension4 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia9 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased4 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension2 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension3 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased4 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension3 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension2 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased2 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia14 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension6 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased2 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia4 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations1 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia2 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia2 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypertension0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPalpitations0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsPyrexia1 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsHypotension0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight increased0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsSystolic hypertension0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Abnormal Vital Signs Reported as TEAEsWeight decreased1 Participants
Primary

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)

Population: Safety analysis set included all participants who received at least one dose of study drug. 'Number of participants analyzed' denotes only those participants for whom hematological and clinical chemistry parameter were analyzed. 'Number Analyzed' denotes the participants analyzed for the specified laboratory parameter.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo9 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes3 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin2 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine2 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper4 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen5 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper2 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo2 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper4 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase3 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets3 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase3 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase5 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo2 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen5 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper7 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes7 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase25 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase13 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo2 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin12 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets5 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin5 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper4 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin5 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo2 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo12 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper4 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase7 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine2 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper8 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase13 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio3 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase4 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper3 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen5 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine3 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin6 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo7 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin4 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo2 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes10 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper14 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper2 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase19 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin6 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo13 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase6 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes4 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase16 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin6 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase5 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin3 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper6 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen2 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper2 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets2 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo2 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen5 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo1 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin3 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper5 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets4 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo1 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase10 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo11 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper3 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes2 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper3 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin9 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin6 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase17 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase8 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time1 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper2 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes8 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo6 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase3 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase4 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin2 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper2 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper2 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets3 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen3 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes2 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets1 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase1 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase1 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin1 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes1 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersBilirubin0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hyper0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hypo0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAspartate Aminotransferase1 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersSodium - Hypo1 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersNeutrophils0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersActivated Partial Thromboplastin Time0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hypo0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersHemoglobin1 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hyper0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlkaline Phosphatase1 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLymphocytes0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPlatelets0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlbumin0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hypo0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersAlanine Aminotransferase0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCreatinine0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersLeukocytes0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersProthrombin Intl. Normalized Ratio0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersMagnesium - Hypo0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersFibrinogen0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersCalcium - Hyper0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersPotassium - Hyper0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Clinically Important Changes in Hematology and Clinical Chemistry ParametersGlucose - Hyper0 Participants
Primary

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

Population: DLT evaluable set included all Part 1A participants who received at least 1 dose of study drug and completed the safety follow-up through the DLT evaluation period (Days 1 to 28 after first dose of study drug) or experienced any DLT.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Primary

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)

Population: Safety analysis set included all participants who received at least one dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree1 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive1 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic1 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris0 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable1 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris1 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation3 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia1 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia1 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris2 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction1 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation1 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation0 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCoronary artery disease0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsTachycardia0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsSinus bradycardia0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure congestive0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac arrest0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrioventricular block first degree0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAcute myocardial infarction0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina pectoris0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAtrial fibrillation0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsAngina unstable0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsMyocardial infarction0 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse EventsCardiac failure chronic0 Participants
Primary

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)

Population: Safety analysis set included all participants who received at least one dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs38 Participants
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs22 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs95 Participants
Parts 2 and 3: Durvalumab 1500 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs45 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs73 Participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs32 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs67 Participants
Parts 2 and 3: Tremelimumab 750 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs36 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs80 Participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs37 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs17 Participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs45 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs1 Participants
China Cohort: Durvalumab 20 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs3 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs5 Participants
China Cohort: Tremelimumab 10 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs3 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TEAEs5 Participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Any TESAEs4 Participants
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

ArmMeasureGroupValue (NUMBER)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments60.0 Percentage of participants
Parts 2 and 3: Durvalumab 1500 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments45.2 Percentage of participants
Parts 2 and 3: Durvalumab 1500 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on BICR37.5 Percentage of participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments50.7 Percentage of participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on BICR45.3 Percentage of participants
Parts 2 and 3: Tremelimumab 750 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on BICR49.3 Percentage of participants
Parts 2 and 3: Tremelimumab 750 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments47.8 Percentage of participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments34.5 Percentage of participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on BICR36.9 Percentage of participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on BICR55.3 Percentage of participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments63.8 Percentage of participants
China Cohort: Durvalumab 20 mg/kgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments33.3 Percentage of participants
China Cohort: Tremelimumab 10 mg/kgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments20.0 Percentage of participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgDisease Control Rate (DCR) Based on Investigator Assessments and BICRDCR based on Investigator assessments16.7 Percentage of participants
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed. The DoR was analyzed for participants who achieved OR per BICR and/or investigator assessments. 'Number Analyzed' denotes participants who achieved OR.

ArmMeasureGroupValue (MEDIAN)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessments16.66 Months
Parts 2 and 3: Durvalumab 1500 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on BICR14.95 Months
Parts 2 and 3: Durvalumab 1500 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessmentsNA Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on BICR18.43 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessments23.95 Months
Parts 2 and 3: Tremelimumab 750 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on BICR23.95 Months
Parts 2 and 3: Tremelimumab 750 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessments27.53 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on BICR13.21 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessments13.21 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on BICRNA Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessments10.51 Months
China Cohort: Durvalumab 20 mg/kgDuration of Response (DoR) Based on Investigator Assessments and BICRDoR based on Investigator assessments7.39 Months
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

ArmMeasureGroupValue (NUMBER)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments20.0 Percentage of participants
Parts 2 and 3: Durvalumab 1500 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments11.5 Percentage of participants
Parts 2 and 3: Durvalumab 1500 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on BICR11.5 Percentage of participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments21.3 Percentage of participants
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on BICR24.0 Percentage of participants
Parts 2 and 3: Tremelimumab 750 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on BICR7.2 Percentage of participants
Parts 2 and 3: Tremelimumab 750 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments8.7 Percentage of participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments8.3 Percentage of participants
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on BICR9.5 Percentage of participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on BICR21.3 Percentage of participants
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments34.0 Percentage of participants
China Cohort: Durvalumab 20 mg/kgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessments33.3 Percentage of participants
China Cohort: Tremelimumab 10 mg/kgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessmentsNA Percentage of participants
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgOverall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)ORR based on Investigator assessmentsNA Percentage of participants
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error.

ArmMeasureValue (MEDIAN)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgOverall Survival (OS)12.58 Months
Parts 2 and 3: Durvalumab 1500 mgOverall Survival (OS)12.91 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgOverall Survival (OS)17.05 Months
Parts 2 and 3: Tremelimumab 750 mgOverall Survival (OS)17.05 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgOverall Survival (OS)11.30 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgOverall Survival (OS)NA Months
China Cohort: Durvalumab 20 mg/kgOverall Survival (OS)30.69 Months
China Cohort: Tremelimumab 10 mg/kgOverall Survival (OS)3.52 Months
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgOverall Survival (OS)6.28 Months
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

ArmMeasureGroupValue (MEDIAN)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments3.52 Months
Parts 2 and 3: Durvalumab 1500 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments2.40 Months
Parts 2 and 3: Durvalumab 1500 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on BICR2.07 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments3.52 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on BICR2.17 Months
Parts 2 and 3: Tremelimumab 750 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on BICR2.69 Months
Parts 2 and 3: Tremelimumab 750 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments2.60 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments1.81 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on BICR1.87 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on BICR4.17 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments6.24 Months
China Cohort: Durvalumab 20 mg/kgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments1.81 Months
China Cohort: Tremelimumab 10 mg/kgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments2.20 Months
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgProgression Free Survival (PFS) Based on Investigator Assessments and BICRPFS based on Investigator assessments1.87 Months
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

ArmMeasureGroupValue (MEDIAN)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments3.68 Months
Parts 2 and 3: Durvalumab 1500 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments3.38 Months
Parts 2 and 3: Durvalumab 1500 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on BICR2.10 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments3.68 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on BICR3.71 Months
Parts 2 and 3: Tremelimumab 750 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on BICR2.76 Months
Parts 2 and 3: Tremelimumab 750 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments2.60 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments1.87 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on BICR1.87 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on BICR4.30 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments7.46 Months
China Cohort: Durvalumab 20 mg/kgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments1.81 Months
China Cohort: Tremelimumab 10 mg/kgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments3.75 Months
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgTime to Progression (TTP) Based on Investigator Assessments and BICRTTP based on Investigator assessments2.68 Months
Secondary

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)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed. The TTR was analyzed for participants who achieved OR per BICR and/or investigator assessments. 'Number Analyzed' denotes participants who achieved OR.

ArmMeasureGroupValue (MEDIAN)
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments2.68 Months
Parts 2 and 3: Durvalumab 1500 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on BICR3.65 Months
Parts 2 and 3: Durvalumab 1500 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments3.68 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on BICR2.28 Months
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments1.86 Months
Parts 2 and 3: Tremelimumab 750 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on BICR1.81 Months
Parts 2 and 3: Tremelimumab 750 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments2.74 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on BICR2.86 Months
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments3.88 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on BICR2.10 Months
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments2.10 Months
China Cohort: Durvalumab 20 mg/kgTime to Response (TTR) Based on Investigator Assessments and BICRTTR based on Investigator assessments5.55 Months

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026