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

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: NCT03666143
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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
Advanced Solid Tumors Drug: Sitravatinib 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : November 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : June 2022
Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Tislelizumab


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs) per NCI-CTCAE version 5.0 [ Time Frame: 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
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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:

  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.

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. Patients with active hepatitis C infection.

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

14. 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

15. Concurrent participation in another therapeutic clinical trial

Contacts and Locations
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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): NCT03666143


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Chair: Cheng Chen Beigene Medical Monitor
More Information
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Publications:
Guo J, Zhou Q, Huang D, Yu X, Zhao J, Chu Q, Ma Z, Millward M, Gao B, Goh J, Markman B, Voskoboynik M, Gan H, Coward J, Chen C, Xiang X, Qui J, Xu Y, Yang L, Wu YL. A phase 1b study to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity of sitravatinib in combination with tislelizumab in patients (pts) with advanced solid tumors. Chinese Society of Clinical Oncology. 2019.

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03666143    
Other Study ID Numbers: BGB-900-103
CTR20181404 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Neoplasms