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

NCT02519348

Description:

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: D4190C00022
  • NCT ID: NCT02519348

Conditions

  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
Durvalumab + tremelimumabDurvalumab & Tremelimumab (Regimen 1)
DurvalumabDurvalumab
TremelimumabTremelimumab
Durvalumab + BevacizumabDurvalumab & Bevacizumab

Purpose

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.

Trial Arms

NameTypeDescriptionInterventions
Durvalumab & Tremelimumab (Regimen 1)ExperimentalDurvalumab in combination with Tremelimumab (Regimen 1)
  • Durvalumab + tremelimumab
DurvalumabExperimentalDurvalumab given as monotherapy
  • Durvalumab
TremelimumabExperimentalTremelimumab given as monotherapy
  • Tremelimumab
Durvalumab & Tremelimumab (Regimen 2)ExperimentalDurvalumab in combination with Tremelimumab (Regimen 2)
  • Durvalumab + tremelimumab
Durvalumab & BevacizumabExperimentalDurvalumab in combination with Bevacizumab
  • Durvalumab + Bevacizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female subjects

          2. 18 years and older (Japan-20 years and older)

          3. Confirmed 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. GI 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
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subjects reporting adverse events and number of subjects reporting serious adverse events.
Time Frame:Screening through 3 months after the last dose of study medication
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate
Time Frame:Screening through 12 months after the last subject is randomized
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:Screening through 12 months after the last subject is randomized
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Screening through 12 months after the last subject is randomized
Safety Issue:
Description:
Measure:PD-L1 expression
Time Frame:Screening through last dose of study medication
Safety Issue:
Description:
Measure:Time to Progression
Time Frame:From the date of first dosing to the first documentation of radiographic disease progression (per RECIST v1.1)
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:Time from the date of first dosing to the first documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first
Safety Issue:
Description:
Measure:Disease Control Rate
Time Frame:Screening through 12 months after the last subject is randomized
Safety Issue:
Description:
Measure:Time to Response
Time Frame:Time from the first dose of investigational product to the first documentation of a subsequently confirmed objective response, assessed up to 24 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:MedImmune LLC

Trial Keywords

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

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