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

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ClinicalTrials.gov Identifier: NCT03666143
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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 : December 2020
Estimated Study Completion Date : June 2021

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 or naïve 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




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 ]


Information from the National Library of Medicine

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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


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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Australia, New South Wales
Blacktown Cancer and Haematology Centre Recruiting
Blacktown, New South Wales, Australia
Australia, Queensland
ICON Cancer Foundation Recruiting
South Brisbane, Queensland, Australia
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia
Monash Health Recruiting
Melbourne, Victoria, Australia
Nucleus Network Recruiting
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research Limited Recruiting
Perth, Western Australia, Australia
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Science Not yet recruiting
Beijing, Beijing, China
Peking University First Hospital Recruiting
Beijing, Beijing, China
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
China, Jilin
The First Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China
China, Shanghai
Renji Hospital Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China
China, Tianjin
Tianjin Medical University Cancer Institute & Hospital Recruiting
Tianjin, Tianjin, China
China, Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310016
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
China
Beijing Cancer Hospital Recruiting
Beijing, China
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Michael Millward, MD Linear Clinical Research Limited

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03666143     History of Changes
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: November 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Immunologic Factors
Physiological Effects of Drugs