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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
CTLA-4/Anti-PD-1 Bispecific Antibody
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.
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.
Objective response rate (ORR)
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)
Time frame: Through study completion, an average of 2 years
The number of participants with adverse events/serious adverse events
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.
Time frame: Through study completion, an average of 2 years
Progression free survival (PFS)
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)
Time frame: Through study completion, an average of 2 years
Duration Of Response (DOR)
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.
Time frame: Through study completion, an average of 2 years
Disease Control Rate (DCR)
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.
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anti- PD-1 and TIGIT bispecific antibody
1000 mg/m2, IV infusion
25 mg/m2, IV infusion
Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Kansas City, Kansas, United States
Research Site
New York, New York, United States
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Chengdu, China
...and 36 more locations
Time frame: At 12 and 24 weeks
Progression free survival (PFS)
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.
Time frame: Through study completion, an average of 2 years
Overall Survival (OS)
OS is defined as the time from the start of study intervention until the date of death due to any cause, whichever occurs first.
Time frame: Through study completion, an average of 2 years
Anti Drug Antibody (ADA)
Incidences of ADAs against novel immunomodulators in serum.
Time frame: Through study completion, an average of 2 years
Pharmacokinetics of novel immunomodulators: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )
Pharmacokinetics of novel immunomodulators: Time to maximum plasma concentration of the study drug (T-max)
Time to maximum observed plasma concentration of the study drug
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )
lmmunogenicity of novel immunomodulators
The number and percentage of participants who develop ADAs.
Time frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years)
Objective response rate (ORR)
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
Time frame: Through study completion, an average of 2 years