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)

JRCT ID: jRCT2031230260

Registered date:27/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma, Biliary Tract Cancer
• Date of first enrollment: 06/09/2023
• Target sample size: 260
• Countries of recruitment: China,Japan,Hong Kong,Japan,Italy,Japan,Republic of Korea,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

- Drug: MEDI5752
CTLA-4/Anti-PD-1 Bispecific Antibody

- Drug: Bevacizumab
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.

- Drug: Lenvatinib
Daily use per oral (8 mg capsules/day for participants less than 60 kg or 12 mg/day for participants 60 kg or more) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

- Drug: AZD2936
anti- PD-1 and TIGIT bispecific antibody

- Drug: Gemcitabine
1000 mg/m2, IV infusion

- Drug : Cisplatin
25 mg/m2, IV infusion

Outcome(s)

Primary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Age 18 years or more 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.

Exclude 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT05775159