MelanomaPhase 2NCT05104801
Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma
A Phase 2 study testing sitravatinib and tislelizumab in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- sitravatinib and tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- Nov 2021to Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Chuanliang Cui, MD contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Chuanliang CUI, MD, 010-88121122, 1008ccl@163.com
About this study
Official title: A Phase II Study Exploring the Safety, Tolerability and Preliminary Anti-tumor Activity of Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma
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.
Read the detailed description
This is an open-label, randomized, single center phase 2 study evaluating the efficacy and safety of sitravatinib in combination with tislelizumab for Chinese patients with unresectable or metastatic melanoma after disease progression from prior anti-PD-1 antibody and chemotherapy. The first 20 patients will be randomized in a 1:1 ratio to receive either sitravatinib plus tislelizumab (Arm A) or sitravatinb monotherapy (Arm B). After the completion of initial 20 patients, additional patients will be recruited until 24 efficacy evaluable patients achieved in Arm A
- Conditions
- Melanoma
- Being tested
- sitravatinib, tislelizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitravatinibDrug
sitravatinib 100mg QD PO
tislelizumabDrug
tislelizumab 200mg Q3W IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: sitravatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
Overall response rate (ORR) in Arm B
defined as the proportion of participants with partial response or complete response as determined by the investigators based on RECIST v1.1
Measured: 12 months
Disease control rate (DCR) in Arm A and B
defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by investigators based on RECIST v1.1
Measured: 12 months
Progression-free survival (PFS) in Arm A and B
defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
Measured: 12 months
Incidence of Treatment-Emergent Adverse Events
According to National Cancer Institute Common Terminology Criteria for Adverse Events V5.0(CTCAE V5.0)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104801
- Sponsor's protocol ID
- BGB-900-2002-IIT
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Exploring the Safety, Tolerability and Preliminary Anti-tumor Activity of Sitravatinib With or Without Tislelizumab in Patients With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT05104801
- Acronym / sponsor ID
- BGB-900-2002-IIT
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, randomized, single center phase 2 study evaluating the efficacy and safety of sitravatinib in combination with tislelizumab for Chinese patients with unresectable or metastatic melanoma after disease progression from prior anti-PD-1 antibody and chemotherapy. The first 20 patients will be randomized in a 1:1 ratio to receive either sitravatinib plus tislelizumab (Arm A) or sitravatinb monotherapy (Arm B). After the completion of initial 20 patients, additional patients will be recruited until 24 efficacy evaluable patients achieved in Arm A
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: tislelizumab+sitravatinib | Experimental | Drug: sitravatinib, Drug: tislelizumabPatients 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. |
| Arm B: sitravatinib | Experimental | Drug: sitravatinibPatients will receive sitravatinib 100 mg orally once daily until disease progression, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sitravatinibsitravatinib 100mg QD PO | Drug | Arm A: tislelizumab+sitravatinib, Arm B: sitravatinib |
| tislelizumabtislelizumab 200mg Q3W IV | Drug | Arm A: tislelizumab+sitravatinib |
Primary outcome
Overall response rate (ORR) in Arm A
Time frame: 12 months
defined as the proportion of participants with partial response or complete response as determined by the investigators based on RECIST v1.1
4 secondary outcomes
Overall response rate (ORR) in Arm B
Time frame: 12 months
Disease control rate (DCR) in Arm A and B
Time frame: 12 months
Progression-free survival (PFS) in Arm A and B
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanliang Cui, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sitravatinib and tislelizumab in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Guo, MD (86-10-88121122, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) in Arm A (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.