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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03680508
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Tesaro, Inc.
Information provided by (Responsible Party):
University of Hawaii

Brief Summary:
TSR-022 and TSR-042 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 and TSR-044 work in combination in treating patients with locally advanced or metastatic liver cancer.

Condition or disease Intervention/treatment Phase
Adult Primary Liver Cancer Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Drug: TSR-022 and TSR-042 Phase 2

Detailed 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 and TSR-042.

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 and TSR-042 on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 9 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of TSR-022 in Combination With TSR-042 for the Treatment of Advanced Hepatocellular Carcinoma
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: TSR-022 and TSR-042
Patients receive TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) via IV day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: TSR-022 and TSR-042
immunotherapy
Other Names:
  • Anti-TIM-3 Antibody
  • Anti-PD-1 Antibody




Primary Outcome Measures :
  1. Objective Response [ Time Frame: From date of treatment until the date of best documented response, assessed up to 36 months ]
    Determined by RECIST v1.1 criteria


Secondary Outcome Measures :
  1. Objective Response (irRC) [ Time Frame: From date of treatment until the date of best documented response, assessed up to 36 months ]
    Objective response as determined by the immune related Response Criteria

  2. Duration of Response [ Time Frame: From date of treatment until the date of progression, assessed up to 36 months ]
    Time from tumor response to progression

  3. Time to progression [ Time Frame: From date of treatment until the date of progression, assessed up to 36 months ]
    Time from treatment to progression of cancer

  4. Progression free survival [ Time Frame: From date of treatment until the date of progression or death, assessed up to 36 months ]
    Time from treatment to progression of cancer or death

  5. Overall survival [ Time Frame: From date of treatment until the date of death, assessed up to 36 months ]
    Time from treatment to death

  6. AFP response [ Time Frame: From treatment start to documentation of AFP progression, assessed up to 36 months. ]
    Percentage of AFP decrease from baseline to nadir

  7. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0 [ Time Frame: From treatment until cessation of study treatment and resolution of adverse events, assessed up to 36 months ]
    Tabulation of adverse events, CTCAE v4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 and renal function
  • 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
  • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

Exclusion Criteria:

  • 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.
  • 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.
  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680508


Contacts
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Contact: Jared D Acoba, MD 8085318521 jacoba@hawaii.edu
Contact: Stacy M Mercado, BA 8084404561 smercado@cc.hawaii.edu

Locations
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United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jared D Acoba, MD    808-531-8521    jacoba@hawaii.edu   
Sponsors and Collaborators
University of Hawaii
Tesaro, Inc.
Investigators
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Principal Investigator: Jared D Acoba, MD University of Hawaii

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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03680508    
Other Study ID Numbers: ACOBA-2017-2
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Hawaii:
immunotherapy
PD-1
TIM-3
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs