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NCT Number: NCT05775159

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Beijing, China

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About this study

This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).

This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.

In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 90 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at the time of signing the ICF.
  • Provision of a signed and dated written ICF.
  • Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
  • Adequate organ and bone marrow function.
  • At least 1 measurable not previously irradiated lesion per RECIST 1.1
  • Life expectancy of at least 12 weeks at the time of screening.
  • Willing and able to provide an adequate tumor sample.

Exclusion criteria

  • History of allogeneic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Uncontrolled intercurrent illness.
  • History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
  • Active infection, brain metastases or spinal cord compression.
  • Participants co-infected with HBV and hepatitis D virus (HDV).
  • Previous treatment in the present study.
  • For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.

Treatment and study plan

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Through study completion, an average of 2 years

    ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)

  2. The number of participants with adverse events/serious adverse events

    Time frame: Through study completion, an average of 2 years

    Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.

  3. Progression free survival (PFS)

    Time frame: Through study completion, an average of 2 years

    PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)

Secondary outcomes

  1. Duration Of Response (DOR)

    Time frame: Through study completion, an average of 2 years

    DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression, whichever occurs first.

  2. Disease Control Rate (DCR)

    Time frame: At 12 and 24 weeks

    DCR at 12 and 24 weeks is defined as the percentage of participants who have a Complete response (CR) or Partial response (PR) in the first 13 and 25 weeks or who have Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.

  3. Progression free survival (PFS)

    Time frame: Through study completion, an average of 2 years

    PFS is defined as the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first.

  4. Overall Survival (OS)

    Time frame: Through study completion, an average of 2 years

    OS is defined as the time from the start of study intervention until the date of death due to any cause, whichever occurs first.

  5. Anti Drug Antibody (ADA)

    Time frame: Through study completion, an average of 2 years

    Incidences of ADAs against novel immunomodulators in serum.

  6. Pharmacokinetics of novel immunomodulators: Maximum plasma concentration of the study drug (Cmax)

    Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )

    Maximum observed plasma concentration of the study drug

  7. Pharmacokinetics of novel immunomodulators: Time to maximum plasma concentration of the study drug (T-max)

    Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )

    Time to maximum observed plasma concentration of the study drug

  8. lmmunogenicity of novel immunomodulators

    Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years)

    The number and percentage of participants who develop ADAs.

  9. Objective response rate (ORR)

    Time frame: Through study completion, an average of 2 years

    ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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