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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05359861




Registration number
NCT05359861
Ethics application status
Date submitted
14/04/2022
Date registered
4/05/2022

Titles & IDs
Public title
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
Scientific title
A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Secondary ID [1] 0 0
SRF388-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SRF388
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Placebo

Experimental: Lead-In - A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.

Experimental: Arm A: SRF388 in Combination with atezolizumab plus bevacizumab - Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.

Experimental: Arm B: Placebo in combination with atezolizumab plus bevacizumab - Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.


Treatment: Drugs: SRF388
SRF388 will be administered by intravenous injection (IV)

Treatment: Drugs: Atezolizumab
Azezolizumab will be administered by IV

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered by IV

Treatment: Drugs: Placebo
Placebo will be administered by IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nature, frequency, and severity of adverse events (AEs) per NCI CTCAE version 5.0 or higher
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Progression Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) according to RECIST v1.1
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
PFS according to HCC modified RECIST (mRECIST)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR) according to RECIST v1.1
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
ORR according to HCC mRECIST
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Duration of Response (DoR) according to RECIST 1.1
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Duration of Response (DoR) according to HCC mRECIST
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
Time to Progression (TTP) according to RECIST v1.1
Timepoint [8] 0 0
Up to 2 years
Secondary outcome [9] 0 0
TTP according to mRECIST
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
Up to 2 years
Secondary outcome [11] 0 0
Time to Response according to RECIST v1.1
Timepoint [11] 0 0
Up to 2 years
Secondary outcome [12] 0 0
Time to Response according to HCC mRECIST
Timepoint [12] 0 0
Up to 2 years
Secondary outcome [13] 0 0
Nature, frequency, and severity of adverse events (AEs) per NCI CTCAE version 5.0 or higher
Timepoint [13] 0 0
Up to 2 years
Secondary outcome [14] 0 0
Incidence of SRF388 Antidrug Antibodies (ADAs)
Timepoint [14] 0 0
Up to 2 years
Secondary outcome [15] 0 0
Incidence of atezolizumab ADAs
Timepoint [15] 0 0
Up to 2 years
Secondary outcome [16] 0 0
Maximum observed serum concentration (Cmax) of SRF388
Timepoint [16] 0 0
Up to 2 years
Secondary outcome [17] 0 0
Time of maximum observed serum concentration (tmax) of SRF388
Timepoint [17] 0 0
Up to 2 years
Secondary outcome [18] 0 0
Area under the serum concentration-time curve from time zero to the last quantifiable time point (AUC0-last)
Timepoint [18] 0 0
Up to 2 years
Secondary outcome [19] 0 0
Terminal elimination half-life (t1/2)
Timepoint [19] 0 0
Up to 2 years
Secondary outcome [20] 0 0
Serum concentrations of atezolizumab
Timepoint [20] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
Abbreviated

* = 18 years of age on day of signing informed consent
* Unresectable locally advanced or metastatic HCC
* No prior systemic treatment for unresectable locally advanced or metastatic HCC
* BCLC Stage B or Stage C disease
* Child-Pugh Class A disease
* = 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Laboratory values indicative of adequate organ function as defined in the protocol
* Women of childbearing potential must have a negative pregnancy test within 1 week prior to first dose of study drug
* Women of childbearing potential or men with a heterosexual partner of childbearing potential or pregnant must agree to refrain from sexual intercourse or be willing to use effective methods of contraception as defined in the protocol while receiving study drug and for 6 months after the last dose of any study drug

Abbreviated
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Previously received an anti-interleukin (IL)-27 antibody (Ab) or anti-IL-27-targeted therapy.
* Received prior systemic therapy for unresectable or metastatic disease. (Note: Prior systemic therapies administered for neoadjuvant, adjuvant, or curative intent (localized disease) are permitted if they were given > 1 year prior to the development of recurrent or metastatic disease)
* Known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
* Moderate or severe ascites
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* History of or current hepatic encephalopathy
* Unable to undergo disease evaluation with a triphasic CT or MRI because of contrast allergy or other contraindication
* Untreated or incompletely treated varices with bleeding or high risk for bleeding.
* Symptomatic or untreated brain metastases or leptomeningeal carcinomatosis.
* Active or history of autoimmune disease or immune deficiency with some exceptions such as controlled thyroid disease, Type 1 diabetes, eczema and other minor skin disorders.
* Medical conditions requiring chronic steroid therapy (ie, > 10 mg/day of prednisone or its equivalent) or anticipates the need for systemic immunosuppressive medications during treatment with study drug
* Known active infection with HIV
* Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), except for controlled active HBV or fully treated HCV infection as defined by the protocol
* Inadequately controlled arterial hypertension

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gyeonggi-Do
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Gyeongsangnam-do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Daegu
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Gyeonggi-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Jeollanam-do
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Taiwan
State/province [16] 0 0
Hualien City
Country [17] 0 0
Taiwan
State/province [17] 0 0
Kao-Hsiung
Country [18] 0 0
Taiwan
State/province [18] 0 0
Kaohsiung
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taichung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Coherus Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Koho Iizuka, MD
Address 0 0
Coherus Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05359861