Trial Title:
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
NCT ID:
NCT05775159
Condition:
Hepatocellular Carcinoma
Biliary Tract Cancer
Conditions: Official terms:
Carcinoma, Hepatocellular
Biliary Tract Neoplasms
Bevacizumab
Gemcitabine
Lenvatinib
Conditions: Keywords:
Hepatobiliary cancer
Hepatocellular carcinoma
Biliary tract cancer
GEMINI-Hepatobiliary
MEDI5752
AZD2936
Bispecific antibody
Volrustomig
Rilvegostomig
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Volrustomig
Description:
CTLA-4/Anti-PD-1 Bispecific Antibody
Arm group label:
Cohort 1A
Arm group label:
Cohort 1B
Arm group label:
Cohort 1C
Arm group label:
Cohort 1D
Arm group label:
Cohort 2B
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
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.
Arm group label:
Cohort 1B
Arm group label:
Cohort 1D
Arm group label:
Cohort 1E
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
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.
Arm group label:
Cohort 1C
Intervention type:
Drug
Intervention name:
Rilvegostomig
Description:
anti- PD-1 and TIGIT bispecific antibody
Arm group label:
Cohort 1D
Arm group label:
Cohort 1E
Arm group label:
Cohort 2A
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000 mg/m2, IV infusion
Arm group label:
Cohort 2A
Arm group label:
Cohort 2B
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
25 mg/m2, IV infusion
Arm group label:
Cohort 2A
Arm group label:
Cohort 2B
Summary:
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.
Detailed description:
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 60 evaluable participants with advanced
BTC who have not received previous treatment for advanced/metastatic disease.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Costa Mesa
Zip:
92627
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90089
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Dyer
Zip:
46311
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kansas City
Zip:
66103
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
101100
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fuzhou
Zip:
350007
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230022
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hong Kong
Zip:
150001
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hong Kong
Zip:
999077
Country:
Hong Kong
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shatin
Zip:
00000
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seongnam-Si
Zip:
463-712
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung city
Zip:
833
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Liuying
Zip:
736
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
11259
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
London
Zip:
NW3 2QG
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Start date:
April 24, 2023
Completion date:
December 14, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775159
