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

STATUS

Recruiting
End date

Oct 17, 2025
participants needed

42
sponsor

University of Hawaii

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Updated on 17 October 2022

See if I qualify

renal function

cirrhosis

liver metastasis

tumor cells

chemoembolization

local therapy

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. 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.

Description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Details

Condition	Adult Primary Liver Cancer, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
Treatment	TSR-022 and TSR-042
Clinical Study Identifier	NCT03680508
Sponsor	University of Hawaii
Last Modified on	17 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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
	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
	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
	Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
	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
	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
Exclusion Criteria
	Participant must not be simultaneously enrolled in any interventional clinical trial
	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
	Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
	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
	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
	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
	Known history of Human Immunodeficiency Virus (HIV) infection
	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
	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
	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
	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 received a live vaccine within 7 days of initiating protocol therapy

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