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.
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
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab + tremelimumab | | Durvalumab & Tremelimumab (Regimen 1) |
Durvalumab | | Durvalumab |
Tremelimumab | | Tremelimumab |
Durvalumab + Bevacizumab | | Durvalumab & 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
Name | Type | Description | Interventions |
---|
Durvalumab & Tremelimumab (Regimen 1) | Experimental | Durvalumab in combination with Tremelimumab (Regimen 1) | - Durvalumab + tremelimumab
|
Durvalumab | Experimental | Durvalumab given as monotherapy | |
Tremelimumab | Experimental | Tremelimumab given as monotherapy | |
Durvalumab & Tremelimumab (Regimen 2) | Experimental | Durvalumab in combination with Tremelimumab (Regimen 2) | - Durvalumab + tremelimumab
|
Durvalumab & Bevacizumab | Experimental | Durvalumab in combination with 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: | Active, not recruiting |
Lead Sponsor: | MedImmune LLC |
Trial Keywords
- Hepatocellular Carcinoma
- Immunotherapy
- Antibodies, Monoclonal
- Tremelimumab
- MEDI4736
- Durvalumab
Last Updated
June 14, 2021