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TerminatedNCT05359861Updated Oct 1, 2026Results posted

Trial of Atezolizumab and Bevacizumab With CHS-388 or Placebo in Patients With Hepatocellular Carcinoma

A Phase 2 interventional study of Casdozokitug and Atezolizumab in Hepatocellular Carcinoma, sponsored by Coherus Oncology, Inc.. Terminated at 37 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Coherus Oncology, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor decision
Updated Oct 1, 2026Now TerminatedResults posted+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This was a Phase 2 trial composed of an open label Lead-In followed by a planned Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.

Only the Lead-In Phase of the study was completed.

Read the detailed description

This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC.

After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Phase 2
  • SRF388
  • IL-27
  • safety
  • efficacy
  • immunotherapy
  • cancer
  • immuno-oncology
  • liver cancer
  • hepatocellular carcinoma
  • atezolizumab
  • Tecentriq
  • bevacizumab
  • Avastin
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 30 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Coherus Oncology, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Abbreviated Inclusion Criteria:

  • ≥ 18 years of age on day of signing informed consent
  • Unresectable locally advanced or metastatic HCC
  • No prior systemic treatment for unresectable locally advanced or metastatic HCC
  • BCLC Stage B or Stage C disease
  • Child-Pugh Class A disease
  • ≥ 1 measurable lesion per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Laboratory values indicative of adequate organ function as defined in the protocol
  • Women of childbearing potential must have a negative pregnancy test within 1 week prior to first dose of study drug
  • Women of childbearing potential or men with a heterosexual partner of childbearing potential or pregnant must agree to refrain from sexual intercourse or be willing to use effective methods of contraception as defined in the protocol while receiving study drug and for 6 months after the last dose of any study drug

Abbreviated Exclusion Criteria:

  • Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Previously received an anti-interleukin (IL)-27 antibody (Ab) or anti-IL-27-targeted therapy.
  • Received prior systemic therapy for unresectable or metastatic disease. (Note: Prior systemic therapies administered for neoadjuvant, adjuvant, or curative intent (localized disease) are permitted if they were given > 1 year prior to the development of recurrent or metastatic disease)
  • Known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Moderate or severe ascites
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • History of or current hepatic encephalopathy
  • Unable to undergo disease evaluation with a triphasic CT or MRI because of contrast allergy or other contraindication
  • Untreated or incompletely treated varices with bleeding or high risk for bleeding.
  • Symptomatic or untreated brain metastases or leptomeningeal carcinomatosis.
  • Active or history of autoimmune disease or immune deficiency with some exceptions such as controlled thyroid disease, Type 1 diabetes, eczema and other minor skin disorders.
  • Medical conditions requiring chronic steroid therapy (ie, > 10 mg/day of prednisone or its equivalent) or anticipates the need for systemic immunosuppressive medications during treatment with study drug
  • Known active infection with HIV
  • Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), except for controlled active HBV or fully treated HCV infection as defined by the protocol
  • Inadequately controlled arterial hypertension
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Lead-In

    A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.

    Drug: Casdozokitug · Drug: Atezolizumab · Drug: Bevacizumab

  • Experimental
    Arm A: SRF388 in Combination with atezolizumab plus bevacizumab

    Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.

    Drug: Casdozokitug · Drug: Atezolizumab · Drug: Bevacizumab

  • Experimental
    Arm B: Placebo in combination with atezolizumab plus bevacizumab

    Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.

    Drug: Atezolizumab · Drug: Bevacizumab · Drug: Placebo

Interventions

  • DrugCasdozokitug

    Casdozokitug will be administered by intravenous injection (IV)

    Also known as: CHS-388, SRF388

  • DrugAtezolizumab

    Atezolizumab will be administered by IV

    Also known as: Tecentriq

  • DrugBevacizumab

    Bevacizumab will be administered by IV

    Also known as: Avastin

  • DrugPlacebo

    Placebo will be administered by IV

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    A TEAE was defined as an AE that emerged or worsened in the period from the first dose of study drug to 30 days after the last dose of study drug. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.

    Time frame: Up to approximately 37 months

Secondary outcomes

  1. Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    PFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to RECIST v1.1 or death due to any cause, whichever occured first. Disease progression was defined according to RECIST v1.1 criteria, including at least a 20% increase in the sum of diameters of target lesions relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 millimeters (mm), or the appearance of one or more new lesions.

    Time frame: Up to approximately 38 months

  2. PFS According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST) (mPFS)

    mPFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to HCC mRECIST or death due to any cause, whichever occured first. Disease progression was defined per HCC mRECIST criteria, including at least a 20% increase in the sum of diameters of target lesions (including viable tumor diameters for typical intrahepatic target lesions and short axis diameters for nodal lesions) relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 mm.

    Time frame: Up to approximately 38 months

  3. Objective Response Rate (ORR) According to RECIST v1.1

    ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST v1.1. * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 mm in short axis. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Time frame: Up to approximately 38 months

  4. ORR According to HCC mRECIST (mORR)

    mORR was defined as the percentage of participants achieving complete response CR and PR per HCC mRECIST. * CR: Disappearance of any intratumoral arterial enhancement in all target lesions.. All pathological lymph nodes must have decreased to \< 10 mm in short axis. * PR: At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions. target lesions, taking as reference the baseline sum diameters.

    Time frame: Up to approximately 38 months

  5. Duration of Response (DoR) According to RECIST 1.1

    DoR was defined as the time from first documentation of CR or PR until the time of the first documentation of PD evaluated using RECIST v1.1 or death due to any cause.

    Time frame: Up to approximately 38 months

  6. DoR According to HCC mRECIST (mDoR)

    mDoR was defined as the time from first documentation of CR or PR until the time of the first documentation of PD evaluated using HCC mRECIST or death due to any cause.

    Time frame: Up to approximately 38 months

  7. Disease Control Rate (DCR) According to RECIST v1.1

    DCR was defined as the percentage of participants who achieved CR, PR, or SD according to RECIST v1.1 for at least 12 weeks.

    Time frame: Up to approximately 38 months

  8. DCR According to HCC mRECIST (mDCR)

    mDCR was defined as the percentage of participants who achieved CR, PR, or SD according to HCC mRECIST for at least 12 weeks.

    Time frame: Up to approximately 38 months

  9. Time to Progression (TTP) According to RECIST v1.1

    TTP was defined as time from study drug initiation to the occurrence of disease progression per RECIST v1.1.

    Time frame: Up to approximately 38 months

  10. TTP According to HCC mRECIST (mTTP)

    mTTP was defined as time from study drug initiation to the occurrence of disease progression per HCC mRECIST.

    Time frame: Up to approximately 38 months

  11. Overall Survival (OS)

    OS was defined as the time from study drug initiation to death from any cause.

    Time frame: Up to approximately 38 months

  12. Time to Response (TTR) According to RECIST v1.1

    TTR was defined as the time from study drug initiation to initial documented objective response per RECIST v1.1.

    Time frame: Up to approximately 38 months

  13. TTR According to HCC mRECIST (mTTR)

    mTTR was defined as the time from study drug initiation to initial documented objective response per HCC mRECIST.

    Time frame: Up to approximately 38 months

  14. Time on Therapy

    Time on therapy was defined as the time from study drug initiation to last treatment.

    Time frame: Up to approximately 38 months

  15. Mean Serum Epstein-Barr Virus Induced Gene 3 (EBI3) Concentration by Best Overall Response (BOR) According to RECIST v1.1

    Baseline Serum EBI3 was collected and is reported by BOR status per RECIST v1.1. * CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in the short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.) * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Time frame: Baseline up to approximately 38 months

  16. PFS According to RECIST v1.1 by Baseline Serum EBI3 Status

    PFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to RECIST v1.1 or death due to any cause, whichever occured first. Disease progression was defined according to RECIST v1.1 criteria, including at least a 20% increase in the sum of diameters of target lesions relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 millimeters (mm), or the appearance of one or more new lesions.

    Time frame: Up to approximately 38 months

  17. TTP According to RECIST v1.1 by Baseline Serum EBI3 Status

    TTP was defined as time from study drug initiation to the occurrence of disease progression per RECIST v1.1.

    Time frame: Up to approximately 38 months

  18. OS by Baseline Serum EBI3 Status

    OS was defined as the time from study drug initiation to death from any cause.

    Time frame: Up to approximately 38 months

07

Results

Posted Oct 1, 2026
Limitations and caveats
Only the Lead-In Phase of the study was completed prior to study termination.

Participant flow

Participant flow — Overall Study
MilestoneCasdozokitug + Atezolizumab + Bevacizumab
Started30
Received at least 1 dose of study treatment30
Completed2
Not completed28
Withdrew: Adverse event1
Withdrew: Death13
Withdrew: Withdrawal by subject5
Withdrew: Study terminated by sponsor9

Outcome measures

PrimaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

A TEAE was defined as an AE that emerged or worsened in the period from the first dose of study drug to 30 days after the last dose of study drug. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.

Time frame:
Up to approximately 37 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsCasdozokitug + Atezolizumab + Bevacizumab
Number of Participants With Treatment-emergent Adverse Events (TEAEs)30
SecondaryProgression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

PFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to RECIST v1.1 or death due to any cause, whichever occured first. Disease progression was defined according to RECIST v1.1 criteria, including at least a 20% increase in the sum of diameters of target lesions relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 millimeters (mm), or the appearance of one or more new lesions.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
monthsCasdozokitug + Atezolizumab + Bevacizumab
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)8.3 (2.0 to 14.5)
SecondaryPFS According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST) (mPFS)

mPFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to HCC mRECIST or death due to any cause, whichever occured first. Disease progression was defined per HCC mRECIST criteria, including at least a 20% increase in the sum of diameters of target lesions (including viable tumor diameters for typical intrahepatic target lesions and short axis diameters for nodal lesions) relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 mm.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
PFS According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST) (mPFS)
monthsCasdozokitug + Atezolizumab + Bevacizumab
PFS According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST) (mPFS)10.3 (2.0 to 20.0)
SecondaryObjective Response Rate (ORR) According to RECIST v1.1

ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST v1.1. * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 mm in short axis. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame:
Up to approximately 38 months
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) According to RECIST v1.1
percentage of participantsCasdozokitug + Atezolizumab + Bevacizumab
Objective Response Rate (ORR) According to RECIST v1.139.3 (21.5 to 59.4)
SecondaryORR According to HCC mRECIST (mORR)

mORR was defined as the percentage of participants achieving complete response CR and PR per HCC mRECIST. * CR: Disappearance of any intratumoral arterial enhancement in all target lesions.. All pathological lymph nodes must have decreased to \< 10 mm in short axis. * PR: At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions. target lesions, taking as reference the baseline sum diameters.

Time frame:
Up to approximately 38 months
Reported as:
Number · percentage of participants
ORR According to HCC mRECIST (mORR)
percentage of participantsCasdozokitug + Atezolizumab + Bevacizumab
ORR According to HCC mRECIST (mORR)44.4 (25.5 to 64.7)
SecondaryDuration of Response (DoR) According to RECIST 1.1

DoR was defined as the time from first documentation of CR or PR until the time of the first documentation of PD evaluated using RECIST v1.1 or death due to any cause.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
Duration of Response (DoR) According to RECIST 1.1
monthsCasdozokitug + Atezolizumab + Bevacizumab
Duration of Response (DoR) According to RECIST 1.1NA (12.7 to NA)
SecondaryDoR According to HCC mRECIST (mDoR)

mDoR was defined as the time from first documentation of CR or PR until the time of the first documentation of PD evaluated using HCC mRECIST or death due to any cause.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
DoR According to HCC mRECIST (mDoR)
monthsCasdozokitug + Atezolizumab + Bevacizumab
DoR According to HCC mRECIST (mDoR)NA (12.7 to NA)
SecondaryDisease Control Rate (DCR) According to RECIST v1.1

DCR was defined as the percentage of participants who achieved CR, PR, or SD according to RECIST v1.1 for at least 12 weeks.

Time frame:
Up to approximately 38 months
Reported as:
Number · percentage of participants
Disease Control Rate (DCR) According to RECIST v1.1
percentage of participantsCasdozokitug + Atezolizumab + Bevacizumab
Disease Control Rate (DCR) According to RECIST v1.160.7 (40.6 to 78.5)
SecondaryDCR According to HCC mRECIST (mDCR)

mDCR was defined as the percentage of participants who achieved CR, PR, or SD according to HCC mRECIST for at least 12 weeks.

Time frame:
Up to approximately 38 months
Reported as:
Number · percentage of participants
DCR According to HCC mRECIST (mDCR)
percentage of participantsCasdozokitug + Atezolizumab + Bevacizumab
DCR According to HCC mRECIST (mDCR)63.0 (42.4 to 80.6)
SecondaryTime to Progression (TTP) According to RECIST v1.1

TTP was defined as time from study drug initiation to the occurrence of disease progression per RECIST v1.1.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
Time to Progression (TTP) According to RECIST v1.1
monthsCasdozokitug + Atezolizumab + Bevacizumab
Time to Progression (TTP) According to RECIST v1.18.1 (2.0 to 13.6)
SecondaryTTP According to HCC mRECIST (mTTP)

mTTP was defined as time from study drug initiation to the occurrence of disease progression per HCC mRECIST.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
TTP According to HCC mRECIST (mTTP)
monthsCasdozokitug + Atezolizumab + Bevacizumab
TTP According to HCC mRECIST (mTTP)8.4 (2.0 to 24.6)
SecondaryOverall Survival (OS)

OS was defined as the time from study drug initiation to death from any cause.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
Overall Survival (OS)
monthsCasdozokitug + Atezolizumab + Bevacizumab
Overall Survival (OS)NA (14.5 to NA)
SecondaryTime to Response (TTR) According to RECIST v1.1

TTR was defined as the time from study drug initiation to initial documented objective response per RECIST v1.1.

Time frame:
Up to approximately 38 months
Reported as:
Mean · months
Time to Response (TTR) According to RECIST v1.1
monthsCasdozokitug + Atezolizumab + Bevacizumab
Time to Response (TTR) According to RECIST v1.13.28 ± 1.433
SecondaryTTR According to HCC mRECIST (mTTR)

mTTR was defined as the time from study drug initiation to initial documented objective response per HCC mRECIST.

Time frame:
Up to approximately 38 months
Reported as:
Mean · months
TTR According to HCC mRECIST (mTTR)
monthsCasdozokitug + Atezolizumab + Bevacizumab
TTR According to HCC mRECIST (mTTR)2.90 ± 1.457
SecondaryTime on Therapy

Time on therapy was defined as the time from study drug initiation to last treatment.

Time frame:
Up to approximately 38 months
Reported as:
Mean · weeks
Time on Therapy
weeksCasdozokitug + Atezolizumab + Bevacizumab
Time on Therapy46.7 ± 43.34
SecondaryMean Serum Epstein-Barr Virus Induced Gene 3 (EBI3) Concentration by Best Overall Response (BOR) According to RECIST v1.1

Baseline Serum EBI3 was collected and is reported by BOR status per RECIST v1.1. * CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in the short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.) * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame:
Baseline up to approximately 38 months
Reported as:
Mean · ng/mL
Mean Serum Epstein-Barr Virus Induced Gene 3 (EBI3) Concentration by Best Overall Response (BOR) According to RECIST v1.1
ng/mLCasdozokitug + Atezolizumab + Bevacizumab: Participants With CRCasdozokitug + Atezolizumab + Bevacizumab: Participants With PRCasdozokitug + Atezolizumab + Bevacizumab: Participants With SDCasdozokitug + Atezolizumab + Bevacizumab: Participants With PDCasdozokitug + Atezolizumab + Bevacizumab: Participants With BOR Not Evaluable
Mean Serum Epstein-Barr Virus Induced Gene 3 (EBI3) Concentration by Best Overall Response (BOR) According to RECIST v1.12.117 ± 1.45132.347 ± 1.09201.572 ± 1.01212.194 ± 1.17753.203 ± 2.9529
SecondaryPFS According to RECIST v1.1 by Baseline Serum EBI3 Status

PFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to RECIST v1.1 or death due to any cause, whichever occured first. Disease progression was defined according to RECIST v1.1 criteria, including at least a 20% increase in the sum of diameters of target lesions relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 millimeters (mm), or the appearance of one or more new lesions.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
PFS According to RECIST v1.1 by Baseline Serum EBI3 Status
monthsCasdozokitug + Atezolizumab + Bevacizumab: Participants With <= Median Baseline EBI3 ConcentrationCasdozokitug + Atezolizumab + Bevacizumab: Participants With > Median Baseline EBI3 Concentration
PFS According to RECIST v1.1 by Baseline Serum EBI3 Status8.1 (1.9 to 24.6)8.4 (1.9 to 20.0)
SecondaryTTP According to RECIST v1.1 by Baseline Serum EBI3 Status

TTP was defined as time from study drug initiation to the occurrence of disease progression per RECIST v1.1.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
TTP According to RECIST v1.1 by Baseline Serum EBI3 Status
monthsCasdozokitug + Atezolizumab + Bevacizumab: Participants With <= Median Baseline EBI3 ConcentrationCasdozokitug + Atezolizumab + Bevacizumab: Participants With > Median Baseline EBI3 Concentration
TTP According to RECIST v1.1 by Baseline Serum EBI3 Status8.1 (1.9 to 24.6)8.4 (1.9 to NA)
SecondaryOS by Baseline Serum EBI3 Status

OS was defined as the time from study drug initiation to death from any cause.

Time frame:
Up to approximately 38 months
Reported as:
Median · months
OS by Baseline Serum EBI3 Status
monthsCasdozokitug + Atezolizumab + Bevacizumab: Participants With <= Median Baseline EBI3 ConcentrationCasdozokitug + Atezolizumab + Bevacizumab: Participants With > Median Baseline EBI3 Concentration
OS by Baseline Serum EBI3 StatusNA (9.5 to NA)19.9 (14.0 to NA)

Adverse events

Collected over Up to approximately 39 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Casdozokitug + Atezolizumab + Bevacizumab13/30 (43.3%)15/30 (50%)30/30 (100%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventCasdozokitug + Atezolizumab + Bevacizumab
SepsisInfections and infestations2/30
ColitisGastrointestinal disorders2/30
Disease progressionGeneral disorders2/30
Anorectal infectionInfections and infestations1/30
CellulitisInfections and infestations1/30
Escherichia bacteraemiaInfections and infestations1/30
PeritonitisInfections and infestations1/30
PneumoniaInfections and infestations1/30
Pneumonia aspirationInfections and infestations1/30
Duodenal perforationGastrointestinal disorders1/30
Most frequent other events
Showing 10 of 166
Most frequent other events
EventCasdozokitug + Atezolizumab + Bevacizumab
ProteinuriaRenal and urinary disorders13/30
Decreased appetiteMetabolism and nutrition disorders12/30
DiarrhoeaGastrointestinal disorders11/30
FatigueGeneral disorders10/30
HypertensionVascular disorders10/30
RashSkin and subcutaneous tissue disorders9/30
PyrexiaGeneral disorders7/30
Platelet count decreasedInvestigations7/30
PruritusSkin and subcutaneous tissue disorders7/30
HeadacheNervous system disorders7/30

Baseline characteristics

The Safety Analysis Set included all participants who received any amount of study drug.

Age, Continuous
Age, Continuous(years)Casdozokitug + Atezolizumab + Bevacizumab
Mean65.0 ± 12.79
Sex: Female, Male
Sex: Female, Male(Participants)Casdozokitug + Atezolizumab + Bevacizumab
Female7
Male23
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Casdozokitug + Atezolizumab + Bevacizumab
Hispanic or Latino3
Not Hispanic or Latino26
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Casdozokitug + Atezolizumab + Bevacizumab
American Indian or Alaska Native0
Asian20
Native Hawaiian or Other Pacific Islander1
Black or African American0
White7
More than one race0
Unknown or Not Reported2
Serum Epstein-Barr Virus Induced Gene 3 Concentration
Serum Epstein-Barr Virus Induced Gene 3 Concentration(nanograms per milliliter (ng/mL))Casdozokitug + Atezolizumab + Bevacizumab
Median1.865 (0.32 to 5.29)
08

Study locations

37 sites
  • University of Arizona Cancer Center - North Campus
    Tucson, Arizona 85719, United States
  • City of Hope
    Duarte, California 91010, United States
  • University of Southern California - Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • University of Florida Health Science Center - Gainesville
    Gainesville, Florida 32610, United States
  • University of Miami, Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
  • Louisville VA Medical Center - Robley Rex VA Medical Center
    Louisville, Kentucky 40206, United States
  • Veterans Affairs Ann Arbor Healthcare System
    Ann Arbor, Michigan 48105, United States
  • University of Michigan Health System (UMHS)
    Ann Arbor, Michigan 48109, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
    New York, New York 10010, United States
  • NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI))
    New York, New York 10016, United States
  • University of Oklahoma Health Sciences Center - Stephenson Cancer Center
    Oklahoma City, Oklahoma 73104, United States
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
  • Sarah Cannon Research Institute - Tennessee Oncology
    Chattanooga, Tennessee 37404, United States
  • Sarah Cannon Research Institute - Tennessee Oncology
    Nashville, Tennessee 37203, United States
  • St George Hospital -Kogarah
    Kogarah, 2217, Australia
  • The Alfred Hospital
    Melbourne, 3004, Australia
  • Royal Melbourne Hospital
    Melbourne, Australia
  • Gold Coast Private Hospital
    Southport, 4215, Australia
  • The Catholic University of Korea - St. Vincent's Hospital
    Suwon, Gyeonggi-do 442-723, South Korea
  • Daegu Catholic University Medical Center (DCUMC)
    Daegu, 705-718, South Korea
  • Chonnam National University (CNU) - Chonnam National University Hwasun Hospital (CNUHH)
    Gwangju, 58128, South Korea
  • Ajou University Hospital
    Gyeonggi-do, 443-721, South Korea
  • CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
    Gyeonggi-do, 463-712, South Korea
  • Seoul National University Bundang Hospital
    Seongnam, 13620, South Korea
  • Severance Hospital
    Seoul, 03722, South Korea
  • Gangnam Severance Hospital - Cancer Hospital
    Seoul, 135-720, South Korea
  • Korea University Medical Center - Korea University Anam Hospital
    Seoul, 136-705, South Korea
  • University of Ulsan College of Medicine - Asan Medical Center (AMC)
    Seoul, 138-736, South Korea
  • Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
    Seoul, 156-707, South Korea
  • Pusan National University Yangsan Hospital
    Yangsan, 50612, South Korea
  • Buddhist Tzu Chi General Hospital - Hualien Tzu Chi Medical Center
    Hualien City, 970, Taiwan
  • Kaohsiung Medical University - Chung-Ho Memorial Hospital
    Kaohsiung City, 807, Taiwan
  • E-Da Cancer Hospital
    Kaohsiung City, 82445, Taiwan
  • Chang Gung Memorial Hospital - Kaohsiung Branch
    Kaohsiung City, Taiwan
  • China Medical University Hospital
    Taichung, 40447, Taiwan
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
09

References and documents

Study documents

  • Study protocol · Sep 19, 2024
  • Statistical analysis plan · Aug 11, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

1 registry update since Sep 25, 2026
Status
Completed→Terminated Sponsor decision
changed Oct 1, 2026
Results
Results posted
posted Oct 1, 2026
Also revised
primary outcomes and interventions
Show all 1 update
  1. Oct 1, 2026
    Completed→Terminated
    Why stopped Sponsor decision
    Results posted
    Primary outcomes Revised (3 changes)
    Interventions Arms or interventions changed
    + 9 other changes: index terms, identifiers, verification date, registry dates, description, secondary outcomes, contact details, site details and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05359861
Lead sponsor
Coherus Oncology, Inc.
Responsible party
Sponsor
First posted
May 4, 2022
Start date
Apr 12, 2022
Primary completion
Jun 30, 2025
Completion
Jul 8, 2025
Results posted
Oct 1, 2026
Last update
Oct 1, 2026

Study contacts

Study Director
study director · Coherus Oncology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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