Melanoma Stage IIIB-IVPhase 2FU-Name-T001NCT04248387
Toripalimab in the Neoadjuvant Treatment of BRAF V600 Wild Type Melanoma
A Phase 2 study testing Toripalimab in people with Melanoma Stage IIIB-IV, run by Fudan University at 1 site in China.
Trial summary
In view of the fact that neoadjuvant therapy for malignant melanoma is in the exploratory stage, and the current data on neoadjuvant immunology are mainly from European and American populations, it is necessary to carry out clinical trials in the status of neoadjuvant immunotherapy for patients with melanoma in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage IIIB-IV
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2019to 30 Apr 2022
- 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
- Patients who can undergo surgery after discussion by three surgeons with a deputy senior title or higher
- Patients with stage III or oligometastasis stage IV malignant melanoma confirmed by histopathology or cytology. Stage III is defined as at least one clinically accessible lymph node metastasis; oligometastasis stage IV is defined as less than 4 metastases and the site of metastasis excludes bone metastases, brain metastases, or other metastases that cannot be completely surgically treated.
- BRAF V600 wild type
- Age ≥ 18 years old
- ECOG score is 0-1, with an estimated overall survival of more than 1 year
- The function of main organs and bone marrow is basically normal:
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- Blood routine: WBC ≥ 3500 / mm3 (3.5 * 109 / L); Neutrophil count (ANC) ≥ 180 / mm3 (1.8 * 109 / L); Platelet count ≥ 125000 / mm3 (125 * 109 / L); Hemoglobin: male ≥ 13g / dl (130g / L); female ≥ 11.5g/dl (115g / L);
- Blood biochemistry: Total bilirubin ≤ 1.5 * ULN (total bilirubin of Gilbert syndrome <3.0mg / dL); Aspartate aminotransferase (AST / SGOT), alanine aminotransferase (ALT / SGPT) and alkaline phosphatase ≤ 2.5 * ULN; Creatinine ≤1.5 * normal upper limit (ULN);
- Coagulation function: The international standard ratio (INR) is less than 1.5 (or the INR value is 2-3 when patients take farwarin stably for a long time), and prothrombin time (PT) is less than 1.5 * ULN;
- Lung function test: Lung diffusion (DLCO) ≥ 70% predicted OR; DLCO <70% but ≥ 55%, and the maximum oxygen uptake (VO2 max) ≥ 10L / min / kg (by cardiopulmonary assessment) or 6 minutes walking test ≥ 500 meters; Patients with DLCO <55% were not included in this study; Pulse oximetry during rest and walking ≥ 92%;
- Heart function test: Baseline ECG showed no prolonged PR interval or atrioventricular block;
- Women should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptive or condom) during the study and within 6 months after the end of the study; women should be negative in serum or urine pregnancy test within 7 days before the study and must be non lactating; men should agree to use contraceptive measures during the study and within 6 months after the end of the study.
- Patients voluntarily joined the study, signed informed consent, and had good compliance and were able to be followed up by the trial staff.
Who cannot join
- A previous history of activity or history of any autoimmune disease (including any history of inflammatory bowel disease), or a history of syndrome requiring treatment with systemic steroids or immunosuppressive drugs (except vitiligo patients);
- Use vaccines against infectious diseases (such as influenza, varicella, etc.) within 4 weeks (28 days) after the start of the study treatment;
- Active systemic infection requiring treatment, positive detection of hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA);
- A known positive medical history or positive test result for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
- Patients with any serious and / or uncontrollable diseases, such as unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, serious uncontrollable arrhythmia; patients with poor blood pressure control (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); active or uncontrollable serious infection; liver diseases such as cirrhosis , decompensated liver disease, chronic active hepatitis; poor control of diabetes mellitus (FBG > 10mmol / L); routine urine test indicated that urine protein was ≥ + +, and confirmed that 24-hour urine protein quantity was > 1.0g;
- A history of psychotropic substance abuse who are unable to quit or have a mental disorder;
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- Have been previously exposed to any anti-tumor treatment, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody or any other antibody targeting T-cell co regulatory pathway), etc.; are currently using tumor related treatment or online anti-cancer drugs; are currently using anticoagulants; have received large-scale surgical treatment in the past 3 weeks;
- Previously had malignant tumors and did not achieve complete remission at least 2 years before the start of the study without other treatments (except skin basal cell carcinoma or cervical carcinoma in situ)；
- A history of previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease, or chest CT scans found any evidence of active pneumonia within 4 weeks before the first study medication;
- Immunosuppressive drugs were used within 2 weeks before the first study drug treatment, excluding local glucocorticoids or prednisone with systemic glucocorticoids no more than 10 mg / day or other glucocorticoids of equivalent dose;
- Pregnant or lactating women;
- Prisoners who have been illegally imprisoned or detained for non-mental or physical (such as infectious) diseases;
- Patients with a bleeding tendency (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogs;
- A history of allergy to the ingredients of the study drug;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Yong Chen, M.D., 18017317571, chenyong@fudan.edu.cn
Wangjun Yan, M.D., 18121299399, yanwj@fudan.edu.cn
About this study
Official title: A Clinical Study on the Efficacy and Safety of Toripalimab in the Neoadjuvant Treatment of BRAF V600 Wild Type Resectable Stage III / IV Malignant Melanoma
In view of the fact that neoadjuvant therapy for malignant melanoma is in the exploratory stage, and the current data on neoadjuvant immunology are mainly from European and American populations, it is necessary to carry out clinical trials in the status of neoadjuvant immunotherapy for patients with melanoma in China. Toripalimab has been extensively studied in the field of malignant melanoma, and its effectiveness and safety have been proven. Therefore, the investigators initiated a single-arm exploratory study to investigate the efficacy and safety of Toripalimab in neoadjuvant treatment of patients with BRAF V600 wild-type malignant melanoma.
- Conditions
- Melanoma Stage IIIB-IV
- Being tested
- Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called JS001
Toripalimab, intravenous drip infusion, a dose of 3 mg / kg once every 2 weeks for a total of two cycles
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab group | Experimental | The subjects in this group receive intravenous drip infusion of Toripalimab at a dose of 3 mg / kg once every 2 weeks for a total of two cycles Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Pathologic complete response rate
Measured: Within one week after operation
Secondary outcomes (3)
EFS rate
Event-free survival rate
Measured: One year after the first intravenous drip
ORR
Objective response rate
Measured: One year after the first intravenous drip
OS
Overall survival
Measured: Three years after the first intravenous drip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start17 Jun 2019
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Stage IIIB-IVStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248387
- Sponsor's protocol ID
- IRB1906203-3
- Acronym
- FU-Name-T001
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Safety of Toripalimab in the Neoadjuvant Treatment of BRAF V600 Wild Type Resectable Stage III / IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT04248387
- Acronym / sponsor ID
- FU-Name-T001 / IRB1906203-3
- Conditions
- Melanoma Stage IIIB-IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 30 Jan 2020 (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 view of the fact that neoadjuvant therapy for malignant melanoma is in the exploratory stage, and the current data on neoadjuvant immunology are mainly from European and American populations, it is necessary to carry out clinical trials in the status of neoadjuvant immunotherapy for patients with melanoma in China. Toripalimab has been extensively studied in the field of malignant melanoma, and its effectiveness and safety have been proven. Therefore, the investigators initiated a single-arm exploratory study to investigate the efficacy and safety of Toripalimab in neoadjuvant treatment of patients with BRAF V600 wild-type malignant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab group | Experimental | Drug: ToripalimabThe subjects in this group receive intravenous drip infusion of Toripalimab at a dose of 3 mg / kg once every 2 weeks for a total of two cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who can undergo surgery after discussion by three surgeons with a deputy senior title or higher
- Patients with stage III or oligometastasis stage IV malignant melanoma confirmed by histopathology or cytology. Stage III is defined as at least one clinically accessible lymph node metastasis; oligometastasis stage IV is defined as less than 4 metastases and the site of metastasis excludes bone metastases, brain metastases, or other metastases that cannot be completely surgically treated.
- BRAF V600 wild type
- Age ≥ 18 years old
- ECOG score is 0-1, with an estimated overall survival of more than 1 year
Key exclusion criteria (15 listed)
- A previous history of activity or history of any autoimmune disease (including any history of inflammatory bowel disease), or a history of syndrome requiring treatment with systemic steroids or immunosuppressive drugs (except vitiligo patients);
- Use vaccines against infectious diseases (such as influenza, varicella, etc.) within 4 weeks (28 days) after the start of the study treatment;
- Active systemic infection requiring treatment, positive detection of hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA);
- A known positive medical history or positive test result for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
- Patients with any serious and / or uncontrollable diseases, such as unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, serious uncontrollable arrhythmia; patients with poor blood pressure control (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); active or uncontrollable serious infection; liver diseases such as cirrhosis , decompensated liver disease, chronic active hepatitis; poor control of diabetes mellitus (FBG > 10mmol / L); routine urine test indicated that urine protein was ≥ + +, and confirmed that 24-hour urine protein quantity was > 1.0g;
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 |
|---|---|---|
| ToripalimabAlso: JS001Toripalimab, intravenous drip infusion, a dose of 3 mg / kg once every 2 weeks for a total of two cycles | Drug | Toripalimab group |
Primary outcome
pCR rate
Time frame: Within one week after operation
Pathologic complete response rate
3 secondary outcomes
EFS rate
Time frame: One year after the first intravenous drip
ORR
Time frame: One year after the first intravenous drip
OS
Time frame: Three years after the first intravenous drip
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
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 Toripalimab in people with Melanoma Stage IIIB-IV, run by Fudan University 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 13 inclusion and 15 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 30 Jan 2020. 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 Yong Chen, M.D. (18017317571, chenyong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: Within one week after operation). 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 30 Jan 2020.