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Adult Primary Liver CancerPhase 2NCT03680508

TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer

A Phase 2 study testing TSR-022 and TSR-042 in people with Adult Primary Liver Cancer and Advanced Adult Primary Liver Cancer, run by University of Hawaii at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) may stop the growth of tumor cells by allowing the immune system to attack the cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TSR-022 and TSR-042
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesUnited States
Study dates
19 Dec 2019to Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 or cytologically confirmed hepatocellular cancer
  • Barcelona Clinic Liver Cancer Stage B or C
  • Cirrhosis grade of Child-Pugh class A or B7
  • Subjects with HBV infection are required to be receiving effective antiviral therapy and have a viral load less than 100 IU/mL. Antiviral therapy is not required for subjects with HCV infection
  • Have at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1)
  • No prior systemic therapy for HCC
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  • Age ≥ 18 years
  • ECOG performance status 0-1
  • Resolved acute effects of any prior therapy to baseline or Grade ≤1 NCI CTCAE
  • Have adequate hematologic function as documented by ANC ≥ 1000/μcl, platelet count ≥ 60,000/μcl, and hemoglobin ≥ 8.5 mg/dl
  • Have adequate renal function as determined by a measured or calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault formula
  • Have adequate hepatic function, as documented by ALT and AST ≤5x upper limit of normal, total bilirubin ≤3 mg/dL, and albumin ≥2.8 g/dL
  • International normalized ratio (INR) or prothrombin time (PT) ≤2× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants
  • Prior local therapy, such as surgery, radioembolization, chemoembolization, or radiofrequency ablation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment
  • Participants must agree to not donate blood during the study or for 90 days after the last dose of protocol therapy
  • Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential.
  • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

Who cannot join

  • Participant must not be simultaneously enrolled in any interventional clinical trial
  • Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
  • Participants must not have received investigational therapy ≤4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
  • Active or untreated central nervous system (CNS) and leptomeningeal metastases are excluded
  • Prior therapy with any medication targeting PD-1, PD-L1, or TIM-3
  • Participant must not have a known hypersensitivity to TSR-042 and TSR-022 components or excipients.
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  • Participants with active malignancy (other than HCC) or a prior malignancy within the past 2 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible
  • Participant must not have serious, uncontrolled medical disorder, or nonmalignant systemic disease. Examples include, but are not limited to uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
  • Unstable angina, new onset angina within last 3 months, myocardial infarction within last 6 months and current congestive heart failure New York Heart Association Class II or higher
  • Known history of Human Immunodeficiency Virus (HIV) infection
  • Active tuberculosis infection or other microbial infection or any active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
  • Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (.ie., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • History of idiopathic pulmonary fibrosis, interstitial lung disease, bronchial asthma, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis
  • History of organ transplantation including allogeneic bone marrow transplantation
  • Participant has a diagnosis of immunodeficiency or has receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
  • Participant has received a live vaccine within 7 days of initiating protocol therapy.
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant, lactating, breastfeeding, or intending to become pregnant during the study and for 180 days after the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Oregon Health & Science University Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Phase II Study of TSR-022 (Cobolimab) in Combination With TSR-042 (Dostarlimab) for the Treatment of Advanced Hepatocellular Carcinoma

TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) may stop the growth of tumor cells by allowing the immune system to attack the cancer. This phase II trial is studying how well TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) work in combination in treating patients with locally advanced or metastatic liver cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the objective response rate (ORR) as determined by RECIST v1.1 of advanced hepatocellular cancer (HCC) patients treated with TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody).

SECONDARY OBJECTIVES:

  1. To determine the ORR as determined by the immune related Response Criteria (irRC), duration of response (DOR), time to progression (TTP), progression free survival (PFS), overall survival (OS), and alpha-fetoprotein (AFP) response of study participants.

II. To evaluate the safety profile of treated patients.

OUTLINE:

Patients receive TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 9 weeks.

Being tested
TSR-022 and TSR-042
Keywords
immunotherapy, PD-1, TIM-3
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSR-022 and TSR-042Drug

    Also called cobolimab, TIM-3 binding antibody, dostarlimab, PD-1 binding antibody

    immunotherapy

Study groups in NCT03680508
Study groupRoleWhat they receive
TSR-022 (Cobolimab) and TSR-042 (Dostarlimab)ExperimentalPatients receive TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) via IV day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: TSR-022 and TSR-042

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Determined by RECIST v1.1 criteria

    Measured: From date of treatment until the date of best documented response, assessed up to 36 months

Secondary outcomes (7)

  1. Objective Response Rate (irRC)

    Objective response as determined by the immune related Response Criteria

    Measured: From date of treatment until the date of best documented response, assessed up to 36 months

  2. Duration of Response

    Time from tumor response to progression

    Measured: From date of treatment until the date of progression, assessed up to 36 months

  3. Time to progression

    Time from treatment to progression of cancer

    Measured: From date of treatment until the date of progression, assessed up to 36 months

  4. Progression free survival

    Time from treatment to progression of cancer or death

    Measured: From date of treatment until the date of progression or death, assessed up to 36 months

  5. Overall survival

    Time from treatment to death

    Measured: From date of treatment until the date of death, assessed up to 36 months

  6. AFP response

    Percentage of AFP decrease from baseline to nadir

    Measured: From treatment start to documentation of AFP progression, assessed up to 36 months.

  7. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0

    Tabulation of adverse events, CTCAE v4.0

    Measured: From treatment until cessation of study treatment and resolution of adverse events, assessed up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2018
  2. Study start19 Dec 2019
  3. Primary completion6 Mar 2026
  4. Study completionOct 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03680508
Sponsor's protocol ID
ACOBA-2017-2
Status last verified
Mar 2026
First submitted
18 Sep 2018
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TSR-022 and TSR-042 in people with Adult Primary Liver Cancer and Advanced Adult Primary Liver Cancer, run by University of Hawaii at 2 sites in United States.

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 17 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: From date of treatment until the date of best documented response, assessed up to 36 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 NCT03680508.

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 2 Apr 2026.

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