Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer

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Brief Title

Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer

Official Title

Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer Who Have Failed to At Least 1 Prior Systemic Treatment

Brief Summary

      This is open-label, phase II study enrolling advanced BTC patients who have failed to
      1st-line chemotherapy.
    

Detailed Description

      

      Primary Objectives:

      To characterize the efficacy of Sitravatinib and Tislelizumab combination in biliary tract
      cancer patients who have failed to 1st-line chemotherapy but no more than 2 lines of prior
      chemotherapy regimen

      Secondary Objectives:

      To see the safety of Sitravatinib and Tislelizumab combination in biliary tract cancer
      patients who have failed to 1st-line chemotherapy

       sitravatinib and tislelizumab may elicit greater antitumor activity, as
      sitravatinib is predicted to enhance several steps in the cancer immunity Cycle that may
      augment the efficacy of tislelizumab. First, the antitumor activity of sitravatinib may
      promote the release of tumor antigens. Second, inhibition of the split kinase receptors
      VEGFR-2 and KIT may decrease the number of Tregs and MDSCs, thus promoting the expansion and
      migration of antitumor cytotoxic T cells, and their infiltration into tumor tissue. Third,
      sitravatinib may reverse the immunosuppressive effects within the tumor microenvironment that
      are mediated by the TAM receptors through inhibition of MERTK, resulting in an increased
      number of M1- versus M2-polarized macrophages and release of IL 12, IL-6, and TNF. These
      downstream effects enhance CD8+ T-cell activation, and through the inhibition of AXL, promote
      increased antigen presentation through termination of the Toll-like receptor dependent
      inflammatory response in dendritic cells.

      In biliary tract cancer, this sitravatinib and tislelizumab combination has not been tested
      so far. In this protocol, we will test sitravatinib and tislelizumab combination in advanced
      biliary tract cancer.

       Selective receptor tyrosine kinases inhibit key molecular and cellular pathways
      strongly implicated in checkpoint inhibitor resistance and therefore represent reasonable
      strategies to enhance or restore antitumor immunity when combined with anti-PD-1 or
      anti-PD-L1 monoclonal antibodies.

       This is open-label, phase II study enrolling advanced BTC patients who have
      failed to 1st-line chemotherapy.

      All patients will receive sitravatinib 120 mg orally once daily in combination with
      tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity,
      or withdrawal of consent.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease control rate

Secondary Outcome

 overall response rate

Condition

Advanced Biliary Tract Cancer

Intervention

Sitravatinib

Study Arms / Comparison Groups

 Sitravatinib/Tislelizumab
Description:  All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

43

Start Date

November 1, 2020

Completion Date

October 31, 2022

Primary Completion Date

October 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  1. Written informed consent and any locally-required authorization obtained from the
             subject prior to performing any protocol-related procedures, including screening
             evaluations 2. Age≥ 20 years at time of study entry 3. Eastern Cooperative Oncology
             Group (ECOG) performance status of 0 or 1 4. Life expectancy of ≥ 16weeks 5.
             Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic
             bile duct cancer, gallbladder cancer, ampulla of vater cancer 6. Unresectable or
             recurrent 7. Failed to 1st-line chemotherapy for their advanced BTC, but no more than
             2 lines of prior chemotherapy regimen 8. At least one measurable lesion that can be
             accurately assessed at baseline by computed tomography (CT) (magnetic resonance
             imaging [MRI] where CT is contraindicated) and is suitable for repeated assessment as
             per RECIST 1.1.

             9. Body weight >30kg 10. Adequate normal organ and marrow function measured within 28
             days prior to administration of study treatment as defined below:

             • Haemoglobin ≥9.0 g/dL

             • Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L

               -  Platelet count ≥ 75 x 10 9/L

               -  Serum creatinine ≤ 1.5 x upper limit of normal (ULN), or estimated glomerular
                  filtration rate ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology
                  Collaboration equation

               -  AST and ALT ≤ 3.0 x ULN, or AST and ALT ≤ 5.0 x ULN for patients with documented
                  liver metastases

               -  Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients
                  with Gilberts syndrome)

               -  International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 x ULN

               -  Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN

                  11. Patients with inactive/asymptomatic carrier, chronic, or active hepatitis B
                  virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500
                  copies/mL) at Screening 12. Females of childbearing potential must be willing to
                  use a highly effective method of birth control for the duration of the study, and
                  ≥ 120 days after the last dose of study drugs and have a negative serum pregnancy
                  test ≤ 7 days of first dose of study drugs 13. Non-sterile males must be willing
                  to use a highly effective method of birth control for the duration of the study
                  and for ≥ 120 days after the last dose of study drugs

        Exclusion Criteria:

          -  1. Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment, defined as follows:

               1. ≥ Grade 3 AE related to anti-PD-1/PD-L1 treatment that did not respond to
                  standard therapy and warranted treatment discontinuation.

               2. ≥ Grade 2 irAE(immune-related adverse event) associated with anti-PD-1/PD-L1
                  unless the AE(adverse event) resolved or was well controlled by withholding the
                  anti-PD-1/PD-L1 and/or treatment with steroids, with the exception of prior
                  colitis, encephalitis, myocarditis, hepatitis, uveitis and pneumonitis, which are
                  exclusionary.

               3. Central nervous system or ocular AE of any grade related to anti-PD-1/PD-L1 Note:
                  Patients with a prior endocrine AE are permitted to enroll if they are stably
                  maintained on appropriate replacement therapy and are asymptomatic.

                  2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis

                  • Patients with a history of treated and, at the time of screening, asymptomatic
                  CNS metastases are eligible, provided they meet all the following:

               1. Brain imaging at screening shows no evidence of interim progression

               2. All brain metastases with supratentorial location

               3. No ongoing requirement for corticosteroids as therapy for CNS disease;
                  anticonvulsants at a stable dose allowed

               4. No stereotactic radiation or whole-brain radiation within 14 days prior to first
                  dose of study drug(s)

                    -  Patients with new asymptomatic central nervous system metastases detected at
                       the screening scan must receive radiation therapy and/or surgery for central
                       nervous system metastases.

               5. Following treatment, these patients may then be eligible, provided all other
                  criteria, including those for patients with a history of brain metastases, are
                  met.

                  3. Active autoimmune diseases or history of autoimmune diseases that may relapse

                  Note: Patients with the following diseases are not excluded and may proceed to
                  further screening:

               6. Controlled Type I diabetes

               7. Hypothyroidism (provided it is managed with hormone replacement therapy only)

               8. Controlled celiac disease

               9. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis,
                  alopecia)

              10. Any other disease that is not expected to recur in the absence of external
                  triggering factors 4. Any active malignancy ≤ 2 years before first dose of study
                  drugs except for the specific cancer under investigation in this study and any
                  locally recurring cancer that has been treated curatively (eg, resected basal or
                  squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the
                  cervix or breast) 5. Any condition that required systemic treatment with either
                  corticosteroids (> 10 mg daily of prednisone or equivalent) or other
                  immunosuppressive medication ≤ 14 days before first dose of study drugs

                  Note: Patients who are currently or have previously been on any of the following
                  steroid regimens are not excluded:

               1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)

               2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with
                  minimal systemic absorption

               3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for
                  contrast dye allergy) or for the treatment of a non-autoimmune condition (eg,
                  delayed-type hypersensitivity reaction caused by contact allergen) 6.
                  Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium,
                  sodium, or corrected calcium despite standard medical management or ≥ Grade 3
                  hypoalbuminemia ≤ 14 days before first dose of study drugs 7. History of
                  interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases,
                  including pulmonary fibrosis, acute lung diseases, etc.

                  8. Severe chronic or active infections (including tuberculosis infection, etc.)
                  requiring systemic antibacterial, antifungal or antiviral therapy, within 14 days
                  prior to first dose of study drugs 9. Known history of HIV infection 10. Active
                  hepatitis C infection (defined by a detectable HCV RNA). 11. Any major surgical
                  procedure requiring general anesthesia ≤ 28 days before first dose of study drugs
                  12. Prior allogeneic stem cell transplantation or organ transplantation 13. Any
                  of the following cardiovascular risk criteria:

               1. Cardiac chest pain, defined as moderate pain that limits instrumental activities
                  of daily living, ≤ 28 days before first dose of study drugs

               2. Symptomatic pulmonary embolism ≤ 28 days before first dose of study drugs

               3. Any history of acute myocardial infarction ≤ 6 months before first dose of study
                  drugs

               4. Any history of heart failure meeting New York Heart Association Classification
                  III or IV ≤ 6 months before first dose of study drugs

               5. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first
                  dose of study drugs

               6. Any history of cerebrovascular accident ≤ 6 months before first dose of study
                  drugs

               7. QTc interval (corrected by Fridericia's method) > 450 msec Note: If QTc interval
                  is > 450 msec on initial electrocardiogram (ECG), a follow up ECG will be
                  performed to confirm result

               8. Cardiac left ventricular ejection fraction ≤ 40% or lower limit of normal as
                  assessed by echocardiography. The same modality used at baseline must be applied
                  for subsequent evaluations.

               9. Any episode of syncope or seizure ≤ 28 days before first dose of study drugs 14.
                  Inadequately controlled hypertension (defined as systolic blood pressure > 150
                  mmHg and/or diastolic blood pressure > 100 mmHg) 15. Hypersensitivity to
                  tislelizumab or sitravatinib, to any ingredient in the formulation, or to any
                  component of the container 16. Bleeding or thrombotic disorders or use of
                  anticoagulants such as warfarin or similar agents requiring therapeutic INR
                  monitoring within 6 months before first dose of study drugs 17. Any systemic
                  chemotherapy within 28 days of the first dose of study drugs or immunotherapy
                  (eg, interleukin, interferon, thymoxin, etc.), hormone therapy, targeted therapy,
                  or any investigational therapies within 14 days or 5 half-lives (whichever is
                  shorter) of first dose of study drugs 18. Any herbal medicine used to control
                  cancer within 14 days of first dose of study drugs 19. Toxicities (as a result of
                  prior anticancer therapy) that have not improved to baseline or stabilized,
                  except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and
                  specific laboratory abnormalities) 20. Administration of live vaccine ≤ 4 weeks
                  prior to first dose of study drugs Note: Seasonal vaccines for influenza are
                  generally inactivated vaccines and are allowed. Intranasal vaccines are live
                  vaccines and are not allowed.

                  21. Underlying medical conditions or alcohol or drug abuse or dependence that
                  will be unfavorable for the administration of study drugs or affect the
                  explanation of drug toxicity or AEs; or expected insufficient compliance during
                  the study according to investigator's judgement 22. Participation in another
                  clinical study, unless it is an observational (non interventional) clinical study
                  or during the follow-up period of an interventional study 23. Inability to
                  swallow capsules or disease significantly affecting gastrointestinal function
                  such as malabsorption syndrome, resection of the stomach or small bowel,
                  bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial
                  or complete bowel obstruction 24. Spinal cord compression in one or more of the
                  following criteria

               1. Not definitively treated with surgery and/or radiation

               2. Treated but without evidence that disease has been clinically stable for > 2
                  weeks prior to first dose of study drugs 25. Pregnant or breastfeeding woman 26.
                  Regardless of the severity, patients with any signs or medical history of
                  bleeding; within 4 weeks prior to allocation, patients with any bleeding events ≥
                  CTCAE level 3, unhealed wounds, ulcers or fractures 27. Patients with
                  artery/venous thrombotic occurred within 6 months before allocation, such as
                  cerebrovascular accident (including temporary ischemic attack), deep vein
                  thrombosis and pulmonary embolism
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Do-Youn Oh, M.D., PhD., +82-2-2072-0701, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT04727996

Organization ID

H-2005-156-1126


Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital

Collaborators

 BeiGene

Study Sponsor

Do-Youn Oh, M.D., PhD., Principal Investigator, Seoul National University Hospital


Verification Date

January 2021