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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
MedImmune LLC
Study ID
NCT02519348
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tremelimumab — BIOLOGICAL
    Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
  • Durvalumab — BIOLOGICAL
    Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
  • Bevacizumab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Oct 19, 2015
Status verified
May 2026
Primary completion
Nov 6, 2020
Completion
Dec 18, 2026

Study Design

Enrollment
433 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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) will receive tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Parts 2 and 3: Durvalumab 1500 mg
    Participants will receive durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
    Participants will receive tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Parts 2 and 3: Tremelimumab 750 mg
    Participants will receive tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
    Participants will receive tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first. Participant recruitment to this arm was closed following protocol amendment 5.
  • Experimental: Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
    Participants will receive durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first
  • Experimental: China Cohort: Durvalumab 20 mg/kg
    Participants will receive durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: China Cohort: Tremelimumab 10 mg/kg
    Participants will receive tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
    Participants will receive tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From Day 1 to Day 28 after first dose of study drug ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteSan FranciscoCalifornia94158-
Research SiteNew HavenConnecticut06510-
Research SiteJacksonvilleFlorida32224-
Research SiteTampaFlorida33612-
Research SiteIndianapolisIndiana46202-
Research SiteBostonMassachusetts02114-
Research SiteNew YorkNew York10065-
Research SiteStony BrookNew York11794-
Research SiteDurhamNorth Carolina27705-
Research SitePortlandOregon97213-
Research SitePhiladelphiaPennsylvania19107-
Research SitePhiladelphiaPennsylvania19111-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75390-
Research SiteSeattleWashington98109-

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