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CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Advanced Cancer

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Nivolumab Injection [Opdivo]
CVM-1118
Sponsored by
TaiRx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Oncology, Hepatocellular Carcinoma (HCC), Nivolumab, Hepatoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18+ (20+ for subjects in Taiwan)
  • Diagnosis of hepatocellular carcinoma

    • Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
  • Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
  • Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C
  • Child-Pugh liver function class A
  • Measurable disease (per mRECIST)
  • ECOG performance status of 0 to 1
  • Adequate laboratory parameters including:

    • AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement)
    • Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome)
    • ANC ≥1500/µL
    • Platelets ≥ 90,000/µL
    • HGB ≥ 9.0 g/dL
    • Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula
    • Serum albumin ≥ 2.8 gm/dL
    • INR ≤ 2.3
    • PT/aPTT ≤ 1.2 x ULN
  • QTcF ≤ 480 msec
  • Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows:

    • Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA <500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent.
    • Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody.

Exclusion Criteria:

  • HCC with portal vein invasion at the main portal branch (Vp4)
  • Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
  • Prior immunotherapy for hepatoma
  • ≤ 7 days from prior limited field palliative irradiation therapy and C1D1
  • ≤ 28 days from prior irradiation therapy and C1D1
  • ≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1
  • ≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1
  • Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints
  • Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1
  • Known CNS metastases
  • Known history of HIV infection
  • Females who are currently pregnant or breast-feeding
  • Known gastrointestinal disease that may significantly alter the absorption of oral medications
  • Psychiatric illness or social situation that would interfere with compliance with study requirements
  • History of clinically significant cardiovascular abnormalities

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Keelung Chang Gung Memorial HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab + CVM-1118

Arm Description

1 Cycle = 28 days Nivolumab, 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting from Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability. CVM-1118, 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects. Escalation of the starting dose will be dependent on the absence of Dose Limiting Toxicity in at least 7 of the initial 10 subjects treated at 200 mg, PO, BID. Individual subjects receiving a starting dose of 200 mg, PO, BID and who tolerate the initial 2 cycles with no more than Grade 2 related toxicity, will have the option of increasing their dose of CVM-1118 to 300 mg, PO, BID (600 mg total daily dose) starting with cycle 3 Tolerable dose of Nivolumab and CVM-1118 will be administered continuously for a 28-day cycle until progressive disease, unacceptable toxicity, or consent withdrawal.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)_mRECIST
Assessment by modified RECIST criteria

Secondary Outcome Measures

Objective Response Rate (ORR)_RECIST v1.1
Assessment by RECIST v1.1 criteria
Duration of response (DoR)
Duration of response (DoR) is defined as time from the first documentation of response to the time of progression
Progression free survival (PFS)
Progression free survival (PFS) is defined as time from the first dose of study drug to the time of progression or death
Overall survival (OS)
Overall survival (OS) is defined as time from first dose of study drug to death
Time to progression (TTP)
Time to progression (TTP) is defined as the time from the first dose of study drug to the time of progression
Disease control rate (DCR)
Disease control rate (DCR) is defined as the sum of complete response (CR), partial response (PR), and stable disease rate (SD)
Rate of Adverse event (AE) and Serious Adverse Event (SAE)
Rate of Adverse event (AE) and Serious Adverse Event (SAE) are assessed using Common Terminology Criteria for Adverse Events v.5 (CTCAE) criteria
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ body temperature by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ blood pressure (both systolic and diastolic blood pressure) by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ Heart rate by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ respiratory rate by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Number of Participants With Abnormal baseline and out-of range Hematology Count by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range coagulation test by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range urinalysis test by CTCAE v5
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Number of patients with abnormalities in electrocardiography (ECG) reporting for PR, QRS, QT, and QTcF intervals
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 will be measured to see maximum exposure after CVM-1118 dosing
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Pharmacodynamics analysis for the relationship of Cmax and ORR
Relationship between Cmax and ORR will be evaluated
Pharmacodynamics analysis for the relationship of AUC and ORR
Relationship between AUC and ORR will be evaluated
Pharmacodynamics analysis for the relationship of Cmax and AE
Relationship between Cmax and AE will be evaluated
Pharmacodynamics analysis for the relationship of AUC and AE
Relationship between AUC and AE will be evaluated

Full Information

First Posted
February 8, 2022
Last Updated
July 19, 2023
Sponsor
TaiRx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05257590
Brief Title
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Official Title
A Phase 2, Open-Label Study of CVM-1118 in Combination With Nivolumab in Subjects With Unresectable Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiRx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.
Detailed Description
Nivolumab, a human IgG4 kappa monoclonal antibody acts as a checkpoint inhibitor, blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2 ) and therefore preventing the activation of T cells from attacking the cancer. Nivolumab is currently approved for several cancer types. To meet the medical need, TaiRx, Inc. develops a new small molecule drug, CVM-1118 can promote apoptosis and delay proliferation. Moreover, CVM-1118 targets the formation of vasculogenic mimicry (VM). VM has been associated with tumor metastasis and poor clinical outcomes. VM is reported to be particularly active in tumor under hypoxia state when patients are treated with the potent vascular endothelial growth factor (VEGF) inhibitor like sorafenib or bevacizumab. Hence, the ability of inhibiting the VM network makes CVM-1118 a potential good combination drug with Nivolumab in advanced diseases such as hepatoma where Nivolumab alone has shown activity. The safety profile of CVM-1118 dosing has been established in the phase 1 study. The analysis of metabolism pathways further showed that the potential drug-drug interactions of CVM-1118 and Nivolumab are very low. Based on the mechanism of actions and the safety analysis of nivolumab and CVM-1118, the design of phase 2 trial with the combination therapy might have great potential for the patients with unresectable advanced HCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Advanced Cancer
Keywords
Oncology, Hepatocellular Carcinoma (HCC), Nivolumab, Hepatoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + CVM-1118
Arm Type
Experimental
Arm Description
1 Cycle = 28 days Nivolumab, 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting from Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability. CVM-1118, 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects. Escalation of the starting dose will be dependent on the absence of Dose Limiting Toxicity in at least 7 of the initial 10 subjects treated at 200 mg, PO, BID. Individual subjects receiving a starting dose of 200 mg, PO, BID and who tolerate the initial 2 cycles with no more than Grade 2 related toxicity, will have the option of increasing their dose of CVM-1118 to 300 mg, PO, BID (600 mg total daily dose) starting with cycle 3 Tolerable dose of Nivolumab and CVM-1118 will be administered continuously for a 28-day cycle until progressive disease, unacceptable toxicity, or consent withdrawal.
Intervention Type
Drug
Intervention Name(s)
Nivolumab Injection [Opdivo]
Other Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab will be administered at 240 mg, IV, Q2 weeks with an option for 480 mg, IV, Q4 weeks starting with Cycle 3 if judged to be reasonable by the investigator based on the safety and tolerability.
Intervention Type
Drug
Intervention Name(s)
CVM-1118
Other Intervention Name(s)
TRX-818
Intervention Description
CVM-1118 will be administered 200 mg, PO, BID with an option to increase the starting dose to 300 mg, PO, BID for the subsequent subjects following assessment of safety data from the initial 10 subjects.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)_mRECIST
Description
Assessment by modified RECIST criteria
Time Frame
24 weeks after the last subject starts CVM-1118
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)_RECIST v1.1
Description
Assessment by RECIST v1.1 criteria
Time Frame
24 weeks after the last subject starts CVM-1118
Title
Duration of response (DoR)
Description
Duration of response (DoR) is defined as time from the first documentation of response to the time of progression
Time Frame
24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose
Title
Progression free survival (PFS)
Description
Progression free survival (PFS) is defined as time from the first dose of study drug to the time of progression or death
Time Frame
24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose
Title
Overall survival (OS)
Description
Overall survival (OS) is defined as time from first dose of study drug to death
Time Frame
24 weeks after the last subject starts CVM-1118 and up to 1 year after the last-dose
Title
Time to progression (TTP)
Description
Time to progression (TTP) is defined as the time from the first dose of study drug to the time of progression
Time Frame
24 weeks after the last subject starts CVM-1118 up to 1 year after the last-dose
Title
Disease control rate (DCR)
Description
Disease control rate (DCR) is defined as the sum of complete response (CR), partial response (PR), and stable disease rate (SD)
Time Frame
24 weeks after the last subject starts CVM-1118 and up to 1 year after the last-dose
Title
Rate of Adverse event (AE) and Serious Adverse Event (SAE)
Description
Rate of Adverse event (AE) and Serious Adverse Event (SAE) are assessed using Common Terminology Criteria for Adverse Events v.5 (CTCAE) criteria
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment by CTCAE v5.
Title
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ body temperature by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ blood pressure (both systolic and diastolic blood pressure) by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ Heart rate by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ respiratory rate by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of Participants With Abnormal baseline and out-of range Hematology Count by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range coagulation test by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range urinalysis test by CTCAE v5
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Number of patients with abnormalities in electrocardiography (ECG) reporting for PR, QRS, QT, and QTcF intervals
Description
Values with CTCAE v5 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.
Time Frame
Starting form the first dose of combination treatment until 28 days (for all AE/SAE) and 90 days (for immune related AE/SAE) following the last dose of treatment
Title
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Description
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 will be measured to see maximum exposure after CVM-1118 dosing
Time Frame
During Cycle 1 and Cycle 2 (each cycle is 28 days)
Title
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Description
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time Frame
During Cycle 1 and Cycle 2 (each cycle is 28 days)
Title
Pharmacodynamics analysis for the relationship of Cmax and ORR
Description
Relationship between Cmax and ORR will be evaluated
Time Frame
During Cycle 1 and Cycle 2 (each cycle is 28 days)
Title
Pharmacodynamics analysis for the relationship of AUC and ORR
Description
Relationship between AUC and ORR will be evaluated
Time Frame
During Cycle 1 and Cycle 2 (each cycle is 28 days)
Title
Pharmacodynamics analysis for the relationship of Cmax and AE
Description
Relationship between Cmax and AE will be evaluated
Time Frame
During Cycle 1 and Cycle 2 (each cycle is 28 days)
Title
Pharmacodynamics analysis for the relationship of AUC and AE
Description
Relationship between AUC and AE will be evaluated
Time Frame
During Cycle 1 and Cycle 2 (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18+ (20+ for subjects in Taiwan) Diagnosis of hepatocellular carcinoma Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion) Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab). Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C Child-Pugh liver function class A Measurable disease (per mRECIST) ECOG performance status of 0 to 1 Adequate laboratory parameters including: AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement) Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome) ANC ≥1500/µL Platelets ≥ 90,000/µL HGB ≥ 9.0 g/dL Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula Serum albumin ≥ 2.8 gm/dL INR ≤ 2.3 PT/aPTT ≤ 1.2 x ULN QTcF ≤ 480 msec Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows: Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA <500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent. Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. Exclusion Criteria: HCC with portal vein invasion at the main portal branch (Vp4) Known history of esophageal varices or gastrointestinal bleeding within the past 3 months Prior immunotherapy for hepatoma ≤ 7 days from prior limited field palliative irradiation therapy and C1D1 ≤ 28 days from prior irradiation therapy and C1D1 ≤ 14 days (or 5 half-lives) from prior systemic anticancer therapy and C1D1 ≤ 28 days from local regional therapy (e.g., trans-arterial embolization, radiofrequency ablation) and C1D1 Presence of other active cancer(s) likely to require treatment in the next two (2) years or likely to impact the assessment of any study endpoints Active bacterial or fungal infection(s) requiring systemic therapy within 7 days prior to C1D1 Known CNS metastases Known history of HIV infection Females who are currently pregnant or breast-feeding Known gastrointestinal disease that may significantly alter the absorption of oral medications Psychiatric illness or social situation that would interfere with compliance with study requirements History of clinically significant cardiovascular abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Ling Chen, PhD
Phone
886-2-2653-5007
Ext
113
Email
yenlingchen@trx.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Jer Chen, MD/PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Nan Lu, MD/Ph.D
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun-Yun Yeh, MD/Ph.D
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan-Shen Shan, MD/PhD
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Jer Chen, MD/PhD
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Hsiang Huang, MD/PhD

12. IPD Sharing Statement

Learn more about this trial

CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma

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