Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma

NCT05104801 | Unknown Phase 2

• 1 other identifier: BGB-900-2002-IIT
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In 2014, an estimated 7,000 patients were diagnosed of melanoma in China. It is growing at an annual rate of 3%-5% and approximately 20,000 new cases are reported each year recently.To date, CFDA only approved dacarbazine as first line chemotherapy and anti-PD-1 antibody monotherapy as second line. There is no standard of care after chemotherapy and anti-PD-1.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) in Arm A

  defined as the proportion of participants with partial response or complete response as determined by the investigators based on RECIST v1.1

  12 months

Secondary Outcomes (4)

• Overall response rate (ORR) in Arm B

  12 months

• Disease control rate (DCR) in Arm A and B

  12 months

• Progression-free survival (PFS) in Arm A and B

  12 months

• Incidence of Treatment-Emergent Adverse Events

  12 months

Study Arms (2)

Arm A: tislelizumab+sitravatinib

EXPERIMENTAL

Patients will receive sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: sitravatinib; Drug: tislelizumab

Arm B: sitravatinib

EXPERIMENTAL

Patients will receive sitravatinib 100 mg orally once daily until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: sitravatinib

Interventions

sitravatinib DRUG

sitravatinib 100mg QD PO

Arm A: tislelizumab+sitravatinib; Arm B: sitravatinib

tislelizumab DRUG

tislelizumab 200mg Q3W IV

Arm A: tislelizumab+sitravatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Disease progression from prior chemotherapy and anti-PD-(L)1 therapy (including sequential or combined therapy, regardless of the order)
• No antiPD-1/PD-L1 related toxicity during the prior treatment
• Have not received other immunotherapy, including but not limited to anti-OX40, anti-TIGIT and anti-CD137, etc.
• BRAF wild-type patients, or patients with BRAF mutations who are not suitable or refused to receive targeted therapy with BRAF inhibitors and/or MEK inhibitors
• Have not been exposed to small molecule targeted drugs with anti-angiogenesis effect, or VEGFR TKI drugs
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate hematologic and end-organ function
• Have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 2 weeks before the start of the study, and have recovered from the acute toxicity of the previous treatment
• 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

You may not qualify if:

• Ocular melanoma
• known NRAS mutations
• Active leptomeningeal disease or brain metastases that are not well controlled.
• History of active autoimmune disease
• 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.
• 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
• Known history of HIV infection
• Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drugs
• Prior allogeneic stem cell transplantation or organ transplantation
• Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation, or to any component of the container
• 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
• Concurrent participation in another therapeutic clinical trial

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

sitravatinib; tislelizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jun Guo, MD

CONTACT

86-10-88121122; guoj307@126.com

Chuanliang Cui, MD

CONTACT

1008ccl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: November 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)