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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A | Experimental | Volrustomig monotherapy |
|
| Cohort 1B | Experimental | Volrustomig combination with bevacizumab |
|
| Cohort 1C | Experimental | Volrustomig combination with lenvatinib |
|
| Cohort 2A | Experimental | Rilvegostomig combination with Gemcitabine and Cisplatin |
|
| Cohort 2B | Experimental | Volrustomig combination with Gemcitabine and Cisplatin |
|
| Cohort 1D | Experimental | Volrustomig combination with rilvegostomig and bevacizumab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volrustomig | Drug | CTLA-4/Anti-PD-1 Bispecific Antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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) | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35233 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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|
| Cohort 1E | Experimental | Rilvegostomig combination with bevacizumab |
|
| 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 |
|
| 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. |
| 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. | 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. | Through study completion, an average of 2 years |
| Anti Drug Antibody (ADA) | Incidences of ADAs against novel immunomodulators in serum. | 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 | 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 | 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. | 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 | Through study completion, an average of 2 years |
| Los Angeles |
| California |
| 90089 |
| United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | Kansas City | Kansas | 66103 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Beijing | 100050 | China |
| Research Site | Beijing | 100142 | China |
| Research Site | Beijing | 101100 | China |
| Research Site | Chengdu | 610000 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chongqing | 400030 | China |
| Research Site | Fuzhou | 350007 | China |
| Research Site | Guangzhou | 510060 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Harbin | 150081 | China |
| Research Site | Nanning | 530021 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Hong Kong | 999077 | Hong Kong |
| Research Site | Shatin | 00000 | Hong Kong |
| Research Site | Florence | 50134 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Rozzano | 20089 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Seongnam-si | 463-712 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Barcelona | 08036 | Spain |
| Research Site | Barcelona | 8035 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Pamplona | 31008 | Spain |
| Research Site | Kaohsiung City | 80756 | Taiwan |
| Research Site | Kaohsiung City | 833 | Taiwan |
| Research Site | Liuying | 736 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| Research Site | Cambridge | CB2 0QQ | United Kingdom |
| Research Site | London | NW3 2QG | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C531958 | lenvatinib |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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