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Master Protocol of Novel Immunomodulators as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hepatobiliary Cancer
EU CTIS ID: 2022-502317-29-00
What this study is testing
1. To assess the efficacy of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors by evaluation of ORR (Objective Response Rate) for sub-study 1 HCC and PFS (Progression-free Survival) for sub-study 2 BTC 2. To assess safety and tolerability of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- HCC only: History of allogeneic organ transplantation or in the waiting-list 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.
- HCC only: History of hepatic encephalopathy within 12 months prior to treatment allocation.
See the full eligibility 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.
- HCC only: History of allogeneic organ transplantation or in the waiting-list 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.
- HCC only: History of hepatic encephalopathy within 12 months prior to treatment allocation.
- Previous treatment in the present study.
- Participants co-infected with HBV and hepatitis D virus (HDV)
- BTC only: History of allogeneic organ transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Taiwan
- Japan
- China
- Korea, Republic of
- Hong Kong
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Taiwan; Japan; China; Korea, Republic of; Hong Kong and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.