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A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.

Sponsor
BeiGene (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03666143
Collaborator
(none)
216
Enrollment
17
Locations
9
Arms
49
Anticipated Duration (Months)
12.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous NSCLC, RCC, OC, or melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until occurrence of PD, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor.

There will be 9 cohorts in the study. Approximately 20 patients will be enrolled into each cohort. The patients will be enrolled according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment.

  • Cohort A: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC

  • Cohort B: Anti-PD-1/PD-L1 antibody naïve metastatic, non-squamous NSCLC

  • Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC

  • Cohort D (China-only): Metastatic or advanced RCC without prior systemic therapy

  • Cohort E: Anti-PD-1/PD-L1 antibody naïve recurrent and platinum resistant epithelial OC

  • Cohort F: Anti-PD-1/PD-L1 antibody treated metastatic, squamous NSCLC • Cohort G: Anti-PD-1/PD-L1 antibody refractory/resistant unresectable or metastatic melanoma

  • Cohort H: PD-L1 positive, aive, advanced or metastatic, non-squamous NSCLC

  • Cohort I: PD-L1 positive,naive, advanced or metastatic, squamous NSCLC

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Actual Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anti-PD-1/PD-L1 antibody refractory/resistant NSCLC

Drug: Sitravatinib
Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
Other Names:
  • Tislelizumab

    		•
    Experimental: Anti-PD-1/PD-L1 antibody naïve NSCLC

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: Anti-PD-1/PD-L1 antibody refractory/resistant RCC

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: Metastatic or advanced RCC without prior systemic therapy

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: Anti-PD-1/PD-L1 naïve recurrent / platinum resistant OC

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: Anti-PD-1/PD-L1 treated metastatic, squamous NSCLC

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: Anti-PD-1/PD-L1 antibody R/R melanoma

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: PD-L1 positive, naïve, advanced or metastatic, non-sq NSCLC

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•
    Experimental: PD-L1 positive, naïve, advanced or metastatic, sq NSCLC

    Drug: Sitravatinib
    Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
    Other Names:
  • Tislelizumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events (AEs) and serious adverse events (SAEs) per NCI-CTCAE version 5.0 [All AEs and SAEs will be reported until either 30 days after last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first. Immune-related should be reported until 90 days after the last dose of tislelizumab]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the Schedule of Assessments

    2. Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)

    3. At least 1 measurable lesion as defined by RECIST v1.1

    4. Provide archival tumor tissue (formalin-fixed paraffin-embedded block [FFPE] with tumor tissue or unstained slides), if available.

    5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

    6. Adequate hematologic and end-organ function

    7. 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

    8. 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

    9. 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.

    2. Active leptomeningeal disease or uncontrolled brain metastasis.

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

    4. Any active malignancy ≤ 2 years

    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

    6. History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung diseases, etc.

    7. 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

    8. Known history of HIV infection

    9. Patients with active hepatitis C infection.

    10. Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drugs

    11. Prior allogeneic stem cell transplantation or organ transplantation

    12. Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation, or to any component of the container

    13. 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

    14. Concurrent participation in another therapeutic clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Blacktown Cancer and Haematology Centre Blacktown New South Wales Australia
    2 ICON Cancer Foundation South Brisbane Queensland Australia
    3 Austin Hospital Heidelberg Victoria Australia
    4 Monash Health Melbourne Victoria Australia
    5 Nucleus Network Melbourne Victoria Australia
    6 Linear Clinical Research Limited Perth Western Australia Australia
    7 Beijing Cancer Hospital Beijing Beijing China
    8 Cancer Hospital Chinese Academy of Medical Science Beijing Beijing China
    9 Peking University First Hospital Beijing Beijing China
    10 Guangdong General Hospital Guangzhou Guangdong China
    11 Sun Yat-Sen University Cancer Center Guangzhou Guangdong China
    12 The First Hospital of Jilin University Changchun Jilin China
    13 Renji Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai China
    14 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China
    15 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China 310016
    16 Zhejiang Cancer Hospital Hangzhou Zhejiang China
    17 Beijing Cancer Hospital Beijing China

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Study Director, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT03666143
    Other Study ID Numbers:
    • BGB-900-103
    • CTR20181404
    First Posted:
    Sep 11, 2018
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Feb 7, 2022