Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05775159
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Volrustomig — DRUG
    CTLA-4/Anti-PD-1 Bispecific Antibody
  • Bevacizumab — DRUG
    15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
  • Lenvatinib — DRUG
    Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
  • Rilvegostomig — DRUG
    anti- PD-1 and TIGIT bispecific antibody
  • Gemcitabine — DRUG
    1000 mg/m2, IV infusion
  • Cisplatin — DRUG
    25 mg/m2, IV infusion

Study Details

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

Key Dates

Start date
Apr 24, 2023
Status verified
Apr 2026
Primary completion
Oct 27, 2026
Completion
Oct 28, 2027

Study Design

Enrollment
294 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1A
    Volrustomig monotherapy
  • Experimental: Cohort 1B
    Volrustomig combination with bevacizumab
  • Experimental: Cohort 1C
    Volrustomig combination with lenvatinib
  • Experimental: Cohort 2A
    Rilvegostomig combination with Gemcitabine and Cisplatin
  • Experimental: Cohort 2B
    Volrustomig combination with Gemcitabine and Cisplatin
  • Experimental: Cohort 1D
    Volrustomig combination with rilvegostomig and bevacizumab
  • Experimental: Cohort 1E
    Rilvegostomig combination with bevacizumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteCosta MesaCalifornia92627-
Research SiteLos AngelesCalifornia90089-
Research SiteOrangeCalifornia92868-
Research SiteMiami BeachFlorida33140-
Research SiteDyerIndiana46311-
Research SiteKansas CityKansas66103-
Research SiteNew YorkNew York10065-
Research SiteDallasTexas75251-
Research SiteFairfaxVirginia22031-

Find similar trials in Birmingham, AL

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By specialty
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By research site
Research Site· Birmingham, ALResearch Site· Costa Mesa, CAResearch Site· Los Angeles, CAResearch Site· Orange, CAResearch Site· Miami Beach, FLResearch Site· Dyer, IN

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