A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03666143 |
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Recruitment Status :
Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : July 19, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors | Drug: Sitravatinib | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| 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 : | November 1, 2018 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | October 2022 |
| 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 |
- 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 ]
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the Schedule of Assessments
- 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)
- At least 1 measurable lesion as defined by RECIST v1.1
- Provide archival tumor tissue (formalin-fixed paraffin-embedded block [FFPE] with tumor tissue or unstained slides), if available.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate hematologic and end-organ function
- 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
- 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
- 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:
- Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment.
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Any active malignancy ≤ 2 years
- 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
- 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
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
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| Study Director: | Study Director | BeiGene |
| 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: | July 19, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |
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Neoplasms |