Advanced Hepatocellular CarcinomaPhase 2NCT04948697
A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
A Phase 2 study testing Ociperlimab, Tislelizumab and BAT1706 in people with Advanced Hepatocellular Carcinoma, run by BeiGene at 28 sites in 2 countries.
Trial summary
This was a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced Hepatocellular Carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Ociperlimab, Tislelizumab and BAT1706
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 20 Aug 2021to 1 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed HCC
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease that was not amenable to or had progressed after loco-regional therapy, and was not amenable to a curative treatment approach
- Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (PD-L1) expression result
- No prior systemic therapy for HCC
- At least 1 measurable lesion as defined per RECIST v1.1
- Adequate organ function during screening and before randomization
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
- Prior history of >= Grade 2 hepatic encephalopathy
- Leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
Show all 13Show fewer
- Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
- Prior allogeneic stem cell transplantation or organ transplantation
- Significant cardiovascular risk factors
- Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Administered a live vaccine <=28 days before randomization
- NOTE: Other protocol Inclusion/Exclusion criteria may apply
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
China23 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hunan Cancer Hospital
Changsha, Hunan, 410013
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, 510080
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Huzhou Central Hospital
Huzhou, Zhejiang, 313003
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang, 834009
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
Ningbo, Zhejiang, 315000
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Taiwan5 sites
National Cheng Kung University Hospital
Tainan, 704
Chi Mei Medical Center
Tainan, 710
National Taiwan University Hospital
Taipei, 100225
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
About this study
Official title: A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
This was a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced Hepatocellular Carcinoma (HCC).
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Ociperlimab, Tislelizumab, BAT1706
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OciperlimabDrug
Also called BGB-A1217
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
TislelizumabDrug
Also called BGB-A317
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
BAT1706Drug
Also called Bevacizumab Injection
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab + BAT1706 | Experimental | Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: BAT1706 |
| Arm B: Tislelizumab + BAT1706 | Experimental | Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. Receives: Drug: Tislelizumab; Drug: BAT1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as Assessed by the Investigator
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (RECIST v1.1). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Secondary outcomes (11)
Duration Of Response (DOR) as Assessed by the Investigator
DOR was defined as the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease or death whichever comes first, assessed based on RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months)
Time to Response (TTR) as Assessed by the Investigator
TTR was defined as the time from the randomization date to the date of first documented partial response (PR) or better by the investigator, assessed based on RECIST v1.1. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the randomization date to the first documentation of response (up to 27 months)
Disease Control Rate (DCR) as Assessed by the Investigator
DCR was defined as the percentage of participants who achieve complete response (CR), partial response (PR) or stable disease (SD), assessed based on RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Clinical Benefit Rate (CBR) as Assessed by the Investigator
CBR was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as >= 24 weeks). Per RECIST 1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Progression-Free Survival (PFS) as Assessed by the Investigator
PFS was evaluated by the investigator according to RECIST version 1.1; and was defined as the time from the randomization date to the date of first documentation of disease progression or date of death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months)
Overall Survival (OS)
OS was defined as the time from the randomization date until the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
Measured: From the randomization date until the date of death from any cause (up to 27 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) and up to 30 days after the last dose of study drug(s), or initiation of new anticancer therapy, whichever occurs first. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study.
Measured: From the date of the first dose of study drug up to 30 days after last dose of study drug (i.e., up to 27 months)
Serum Concentrations of Ociperlimab
Serum samples were assayed for ociperlimab concentrations using a validated immunoassay. This outcome measure was not analyzed for Arm B as ociperlimab was not administered in Arm B.
Measured: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)
Serum Concentrations of Tislelizumab
Serum samples were assayed for tislelizumab concentrations using a validated immunoassay.
Measured: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)
Serum Concentrations of BAT1706
Serum samples were assayed for BAT1706 concentrations using a validated immunoassay.
Measured: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706
Serum samples were tested for the presence of ADAs to ociperlimab, tislelizumab and BAT1706 using a validated immunoassay. The analysis included: Treatment-emergent ADA: sum of treatment-boosted ADA patients and treatment-induced ADA participants as a percentage of the ADA-evaluable participants population; Treatment-boosted ADA: Baseline-positive ADA-evaluable patients with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period; and Treatment-induced ADA: ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start20 Aug 2021
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948697
- Sponsor's protocol ID
- AdvanTIG-206
- Other IDs
- CTR20211546
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2021
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ren Z, Huang Y, Guo Y, Hou MM, Wang W, Kuang M, Hao C, Wang W, Zhang Y, Song T, Dai C, Kuo HT, Bao Z, Zuo Y, Wang L, Zhu F, Fan J. AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma. Cancer Immunol Immunother. 2026 Apr 28;75(5):158. doi: 10.1007/s00262-026-04399-8.
PubMed 42047833
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04948697
- Acronym / sponsor ID
- AdvanTIG-206
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced Hepatocellular Carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab + BAT1706 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: BAT1706Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
| Arm B: Tislelizumab + BAT1706 | Experimental | Drug: Tislelizumab, Drug: BAT1706Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed HCC
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease that was not amenable to or had progressed after loco-regional therapy, and was not amenable to a curative treatment approach
- Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (PD-L1) expression result
- No prior systemic therapy for HCC
- At least 1 measurable lesion as defined per RECIST v1.1
Key exclusion criteria (13 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
- Prior history of >= Grade 2 hepatic encephalopathy
- Leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OciperlimabAlso: BGB-A1217900 mg intravenously once every 3 weeks (dosed in 21-day cycles) | Drug | Arm A: Ociperlimab + Tislelizumab + BAT1706 |
| TislelizumabAlso: BGB-A317200 mg intravenously once every 3 weeks (dosed in 21-day cycles) | Drug | Arm A: Ociperlimab + Tislelizumab + BAT1706, Arm B: Tislelizumab + BAT1706 |
| BAT1706Also: Bevacizumab Injection15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles) | Drug | Arm A: Ociperlimab + Tislelizumab + BAT1706, Arm B: Tislelizumab + BAT1706 |
Primary outcome
Objective Response Rate (ORR) as Assessed by the Investigator
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (RECIST v1.1). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
11 secondary outcomes
Duration Of Response (DOR) as Assessed by the Investigator
Time frame: From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months)
Time to Response (TTR) as Assessed by the Investigator
Time frame: From the randomization date to the first documentation of response (up to 27 months)
Disease Control Rate (DCR) as Assessed by the Investigator
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Clinical Benefit Rate (CBR) as Assessed by the Investigator
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Progression-Free Survival (PFS) as Assessed by the Investigator
Time frame: From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months)
Overall Survival (OS)
Time frame: From the randomization date until the date of death from any cause (up to 27 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From the date of the first dose of study drug up to 30 days after last dose of study drug (i.e., up to 27 months)
Serum Concentrations of Ociperlimab
Time frame: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)
Serum Concentrations of Tislelizumab
Time frame: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)
Serum Concentrations of BAT1706
Time frame: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706
Time frame: Up to 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42047833Ren Z, Huang Y, Guo Y, Hou MM, Wang W, Kuang M, Hao C, Wang W, Zhang Y, Song T, Dai C, Kuo HT, Bao Z, Zuo Y, Wang L, Zhu F, Fan J. AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma. Cancer Immunol Immunother. 2026 Apr 28;75(5):158. doi: 10.1007/s00262-026-04399-8.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ociperlimab, Tislelizumab and BAT1706 in people with Advanced Hepatocellular Carcinoma, run by BeiGene at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as Assessed by the Investigator (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.