Advanced MelanomaPhase 2NCT05274438
Imatinib and Toripalimab in Patients With Locally Advanced/Metastatic Melanoma Harbored With CKIT Mut
A Phase 2 study testing JS001+Imatinib mesylate in people with Advanced Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
It is a single-center, single-arm Phase II clinical study. This clinical trial aimed to evaluate the PFS of imatinib combined with toripalimab in stage III unresectable and stage IV melanoma with CKIT gene mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- JS001+Imatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2021to 30 Apr 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
- Age ≥18, no gender limitation;
- Patients with recurrent, unresectable or metastatic melanoma confirmed by histopathology after surgery (stage III/IV);
- With CKIT gene mutation;
- Did not receive CKIT inhibitor or PD-1/PD-L1 mab treatment in late stage; Adjuvant therapy Patients who have received CKIT inhibitors or PD-1/PD-L1 mab should be discontinued for at least 6 months;
- ECOG score is 0 or 1;
- Expected survival ≥3 months;
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- The investigator assessed the presence of at least one measurable lesion that had not been irradiated according to RECIST 1.1;
- No history of brain/meningeal metastasis;
- The organ function level must meet the following requirements (7 days before the first administration of the study drug):
- Spinal cord: Neutrophil absolute count (ANC)≥1.5×109/L, platelet (PLT)≥ 100×109/L, and hemoglobin (HB)≥9g/dL(no blood transfusion or component blood was received within 14 days prior to test); Gallo liver: Serum total bilirubin (TBIL)≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal ( allows AST and ALT≤5 times the upper limit of normal if liver metastasis is present); serum creatinine ≤1.5 times the upper limit of normal value and endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula); Accidence International standardized ratio (INR), activated partial thrombin time (aPTT)≤1.5 times the upper limit of normal value (only for patients not receiving anticoagulant therapy; Patients receiving anticoagulant therapy should keep the anticoagulant within the therapeutic range); Thyroid stimulating hormone (TSH)≤1×ULN (if abnormal, FT3 and FT4 levels should be investigated simultaneously; if FT3 and FT4 levels are normal, they can be included in the group) Isogenic urinary protein ≤1+, isogenic urinary protein \& GT; 1+, urine protein should be collected for 24 hours, and the total amount should be less than or equal to 1 g; Unconsciously the heart functions normally, meaning normal or abnormal ECG has no clinical significance, while cardiac ultrasound shows left ventricular ejection fraction (LVEF) greater than 50%.
- Serum pregnancy test results of women of childbearing age should be negative within 7 days before the first administration of the test drug; Men who are fertile or women who are at risk of becoming pregnant must use a highly effective method of contraception (e.g., oral contraceptives, intrauterine devices, abstinence of sex or barrier contraception combined with spermicide) throughout the trial and continue to use contraception for 180 days after completion of treatment;
- Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Who cannot join
- Advanced treatment with CKIT inhibitors or PD-1/PD-L1 mab; Adjuvant therapy received CKIT inhibitor or PD-1/PD-L1 mab, and the drug withdrawal was less than 6 months;
- Associated with cerebral/meningeal metastasis;
- Patients who participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the first administration of the study drug;
- The study drug underwent/underwent major surgery or had not yet recovered from the side effects of the surgery, received live vaccination, immunotherapy, and received radiotherapy within 2 weeks before the first administration of the study drug;
- The patient has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism); Vitiligo that does not require systemic treatment may be included; Asthma with complete remission in childhood and without any intervention in adulthood could be included; Patients with asthma requiring medical intervention with bronchodilators were excluded);
- The patient is on immunosuppressant, or systemic hormone therapy for immunosuppression purposes (dose \> 10mg/ day of prednisone or other equivalent hormone) and continued to use within 2 weeks prior to enrollment;
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- A history of malignancies other than melanoma in the past 5 years, with the exception of cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early-stage prostate cancer and carcinoma in situ of the cervix;
- Patients who had received hematopoietic stimulating factors, such as granulocyte colony stimulating factor (G-CSF) and erythropoietin, within 1 week before the first drug administration;
- Positive HIV antibody or treponema pallidum antibody;
- Patients with active hepatitis B or C:
- If HBsAg or HBcAb is positive, add test for HBV DNA(test result is higher than the upper limit of the normal range).
- If HCV antibody test result is positive, add test HCV RNA(test result is higher than normal value fan circumference upper limit);
- Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; Known to be allergic to imatinib mesylate and any excipients;
- Large pleural effusion, ascites and pericardial effusion accompanied by clinical symptoms and requiring symptomatic treatment;
- History of active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis;
- Have any clinical problems beyond control, including but not limited to:
- Either a persistent or active (severe) infection; Hypoglycemic medication for poorly controlled hypertension (persistent blood pressure greater than 150/90 MMHG) Buying something to control diabetes poorly; Buying a ticket for heart disease (class III/IV congestive heart failure or heart block, as defined by the New York Cardiology Society); Anyway, something happened during the first six months before taking the drug: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism;
- Any conditions of the patient that affect the ingestion of the drug by the subject, and any conditions that affect the in-body disposal of the drug (absorption, distribution, metabolism or excretion);
- Abnormal coagulation (INR\> 2.0, PT\> 16s), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy, and are allowed to use low-dose aspirin and low-molecular weight heparin prophylacically;
- The group of the first 3 months there have been significant clinical significance of bleeding symptoms or have a definite bleeding tendency, such as daily cough/haemoptysis 2.5 ml and above, gastrointestinal bleeding, there is a risk of bleeding of esophageal gastric varices, hemorrhagic peptic ulcers, or patients with vasculitis, baseline period if defecate occult blood positive, to review, after review if still positive, the need for gastroscopy, If severe esophagogastric fundus varices were indicated by gastroscopy, they could not be enrolled in the group (except those who were excluded by gastroscopy within 3 months before enrollment).
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulopathy, thrombocytopenia, etc.);
- Have undergone a stem cell or organ transplant;
- Those who have a history of psychotropic drug abuse and cannot get rid of it or have a history of mental disorders;
- The investigator identifies other severe, acute, or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or may interfere with the interpretation of study results;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Guo, Director, 13911233048, guoj307@126.com
About this study
Official title: A Single-arm, Phase II Clinical Study of Imatinib Mesylate Combined With Toripalimab in the Treatment of Stage III Unresectable and Stage IV Melanoma Harbored With CKIT Mut
It is a single-center, single-arm Phase II clinical study. This clinical trial aimed to evaluate the PFS of imatinib combined with toripalimab in stage III unresectable and stage IV melanoma with CKIT gene mutation.
Read the detailed description
This study consisted of two phases: the first phase was the dose exploration phase, and the second phase was the extension group. In phase I, 3 patients were enrolled, starting with imatinib monotherapy, 400mg qd, for 2 cycles (6 weeks), followed by imatinib 400mg qd combined with toripalimab 240mg q3w. If DLT was not observed, the original dose was extended to 37 patients in phase ii; If there was 1 DLT in the first stage, the number of patients in the first stage was extended to 6. If there was no DLT, the patients entered the extended stage. If ≥2 DLT cases occurred in the first phase, imatinib was reduced to 300mg QD and toripalimab 240mg q3W, and the "3+3" study was restarted. If DLT≤1 case, enter extended group (imatinib 300mg qd and toripalimab 240mg q3W); The longest cumulative use period of the two drugs was 2 years. When patients develop disease progression or develop intolerable toxicity, treatment is ended and follow-up for survival is entered.
- Conditions
- Advanced Melanoma
- Being tested
- JS001+Imatinib mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS001+Imatinib mesylateDrug
This study consisted of two phases: the first phase was the dose exploration phase, and the second phase was the extension group. In phase I, 3 patients were enrolled, starting with imatinib monotherapy, 400mg qd, for 2 cycles (6 weeks), followed by imatinib 400mg qd combined with toripalimab 240mg q3w. If DLT was not observed, the original dose was extended to 37 patients in phase ii; If there was 1 DLT in the first stage, the number of patients in the first stage was extended to 6. If there was no DLT, the patients entered the extended stage. If ≥2 DLT cases occurred in the first phase, imatinib was reduced to 300mg QD and toripalimab 240mg q3W, and the "3+3" study was restarted. If DLT≤1 case, enter extended group (imatinib 300mg qd and toripalimab 240mg q3W); The longest cumulative use period of the two drugs was 2 years. When patients develop disease progression or develop intolerable toxicity, treatment is ended and follow-up for survival is entered.
| Study group | Role | What they receive |
|---|---|---|
| JS001+Imatinib Mesylate | Experimental | Imatinib: 400mg qd po. Toripalimab: 240mg q3w ivgtt. The longest cumulative use period of the two drugs was 2 years. Receives: Drug: JS001+Imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To evaluate progression-free survival (PFS) based on RECIST 1.1 criteria.
Measured: 2 years
Secondary outcomes (4)
Overall response rate (ORR)
To evaluate the overall response rate (ORR) based on RECIST 1.1 criteria.
Measured: 2 years
Disease control rate (DCR)
To evaluate the disease control rate (DCR) based on RECIST 1.1 criteria.
Measured: 2 years
Overall survival (OS)
To evaluate overall survival (OS) based on RECIST 1.1 criteria.
Measured: 2 years
Safety(AE,SAE)
To evaluate safety(AE,SAE) of imatinib mesylate combined with terriprizumab in patients with stage III unresectable and stage IV melanoma with CKIT gene mutation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start26 Jan 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- 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
- Investigators
- jun Guo, Diretcor, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274438
- Sponsor's protocol ID
- JS001-ISS-CO208
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo J, Si L, Kong Y, Flaherty KT, Xu X, Zhu Y, Corless CL, Li L, Li H, Sheng X, Cui C, Chi Z, Li S, Han M, Mao L, Lin X, Du N, Zhang X, Li J, Wang B, Qin S. Phase II, open-label, single-arm trial of imatinib mesylate in patients with metastatic melanoma harboring c-Kit mutation or amplification. J Clin Oncol. 2011 Jul 20;29(21):2904-9. doi: 10.1200/JCO.2010.33.9275. Epub 2011 Jun 20.
PubMed 21690468
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Clinical Study of Imatinib Mesylate Combined With Toripalimab in the Treatment of Stage III Unresectable and Stage IV Melanoma Harbored With CKIT Mut
- ClinicalTrials.gov ID
- NCT05274438
- Acronym / sponsor ID
- JS001-ISS-CO208
- Conditions
- Advanced 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
- 26 Jan 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 10 Mar 2022 (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.
It is a single-center, single-arm Phase II clinical study. This clinical trial aimed to evaluate the PFS of imatinib combined with toripalimab in stage III unresectable and stage IV melanoma with CKIT gene mutation.
Detailed description
This study consisted of two phases: the first phase was the dose exploration phase, and the second phase was the extension group. In phase I, 3 patients were enrolled, starting with imatinib monotherapy, 400mg qd, for 2 cycles (6 weeks), followed by imatinib 400mg qd combined with toripalimab 240mg q3w. If DLT was not observed, the original dose was extended to 37 patients in phase ii; If there was 1 DLT in the first stage, the number of patients in the first stage was extended to 6. If there was no DLT, the patients entered the extended stage. If ≥2 DLT cases occurred in the first phase, imatinib was reduced to 300mg QD and toripalimab 240mg q3W, and the "3+3" study was restarted. If DLT≤1 case, enter extended group (imatinib 300mg qd and toripalimab 240mg q3W); The longest cumulative use period of the two drugs was 2 years. When patients develop disease progression or develop intolerable toxicity, treatment is ended and follow-up for survival is entered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS001+Imatinib Mesylate | Experimental | Drug: JS001+Imatinib mesylateImatinib: 400mg qd po. Toripalimab: 240mg q3w ivgtt. The longest cumulative use period of the two drugs was 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18, no gender limitation;
- Patients with recurrent, unresectable or metastatic melanoma confirmed by histopathology after surgery (stage III/IV);
- With CKIT gene mutation;
- Did not receive CKIT inhibitor or PD-1/PD-L1 mab treatment in late stage; Adjuvant therapy Patients who have received CKIT inhibitors or PD-1/PD-L1 mab should be discontinued for at least 6 months;
- ECOG score is 0 or 1;
Key exclusion criteria (24 listed)
- Advanced treatment with CKIT inhibitors or PD-1/PD-L1 mab; Adjuvant therapy received CKIT inhibitor or PD-1/PD-L1 mab, and the drug withdrawal was less than 6 months;
- Associated with cerebral/meningeal metastasis;
- Patients who participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the first administration of the study drug;
- The study drug underwent/underwent major surgery or had not yet recovered from the side effects of the surgery, received live vaccination, immunotherapy, and received radiotherapy within 2 weeks before the first administration of the study drug;
- The patient has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism); Vitiligo that does not require systemic treatment may be included; Asthma with complete remission in childhood and without any intervention in adulthood could be included; Patients with asthma requiring medical intervention with bronchodilators were excluded);
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 |
|---|---|---|
| JS001+Imatinib mesylateThis study consisted of two phases: the first phase was the dose exploration phase, and the second phase was the extension group. In phase I, 3 patients were enrolled, starting with imatinib monotherapy, 400mg qd, for 2 cycles (6 weeks), followed by imatinib 400mg qd combined with toripalimab 240mg q3w. If DLT was not observed, the original dose was extended to 37 patients in phase ii; If there was 1 DLT in the first stage, the number of patients in the first stage was extended to 6. If there was no DLT, the patients entered the extended stage. If ≥2 DLT cases occurred in the first phase, imatinib was reduced to 300mg QD and toripalimab 240mg q3W, and the "3+3" study was restarted. If DLT≤1 case, enter extended group (imatinib 300mg qd and toripalimab 240mg q3W); The longest cumulative use period of the two drugs was 2 years. When patients develop disease progression or develop intolerable toxicity, treatment is ended and follow-up for survival is entered. | Drug | JS001+Imatinib Mesylate |
Primary outcome
Progression-free survival (PFS)
Time frame: 2 years
To evaluate progression-free survival (PFS) based on RECIST 1.1 criteria.
4 secondary outcomes
Overall response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Safety(AE,SAE)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 21690468Guo J, Si L, Kong Y, Flaherty KT, Xu X, Zhu Y, Corless CL, Li L, Li H, Sheng X, Cui C, Chi Z, Li S, Han M, Mao L, Lin X, Du N, Zhang X, Li J, Wang B, Qin S. Phase II, open-label, single-arm trial of imatinib mesylate in patients with metastatic melanoma harboring c-Kit mutation or amplification. J Clin Oncol. 2011 Jul 20;29(21):2904-9. doi: 10.1200/JCO.2010.33.9275. Epub 2011 Jun 20.
- 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.
jun Guo, Diretcor study chair
Peking University Cancer Hospital & Institute
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 JS001+Imatinib mesylate in people with Advanced 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 12 inclusion and 24 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 10 Mar 2022. 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 lu Si, professor (13810700214, silu15_silu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274438, which also lists 1 linked publication.
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 10 Mar 2022.