Clinical Stage III Cutaneous Melanoma AJCC v8Phase 2NCT05907512
Endostar Plus Toripalimab as Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma
A Phase 2 study testing Endostar and Toripalimab in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Endostar combined with Toripalimab in the adjuvant treatment of resectable stage III-oligometastatic stage IV melanoma, and to find effective biomarkers of efficacy based on tumor paraffin tissue specimens and peripheral blood. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
- What is being tested?
- Endostar and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Aug 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Age ≤ age ≤75 years old;
- ECOG performance status: 0 - 1 score;
- Patients with malignant melanoma confirmed by pathology and/or cytology, except mucosal malignant melanoma and uveal malignant melanoma;
- Patients who have not received anti-tumor therapy at the initial stage of treatment;
- 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;
- Complete surgical resection within 13 weeks prior to enrollment;
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- Laboratory tests are required to meet:
- Blood routine examination: hemoglobin (Hb) ≥90g/L (no blood transfusion within 14 days); Absolute neutrophil count (NEUT) ≥1.5×109/L; Platelet (PLT) ≥100×109/L;
- Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN and creatinine clearance 50μmol/L;
- Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
- Women should agree that they must use contraception (e.g., intrauterine device [IUD], birth control pills, or condoms) during the study and for 6 months after the end of the study; A negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraception during the study and for 6 months after the end of the study period;
- 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
- Patients with a history of allergic reactions to biological products;
- Patients with previous or concurrent malignancies within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Any active autoimmune disease or history of autoimmune disease (such as, but not limited to, Autoimmune hepatitis, interstitial pneumonia, enteritis, Vasculitis, nephritis; asthma in which the subject needs medical intervention with Bronchiectasis cannot be included); However, the following patients are allowed to be included: Vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;
- Patients who need to use immunosuppressants, or systemic or absorbable local hormone therapy to achieve immunosuppression (dose>10mg/day prednisone or other equivalent therapeutic hormone), and continue to use within 2 weeks after the first administration;
- Patients with any signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event ≥CTCAE Grade 3 within 4 weeks prior to the first dose; Or digestive tract diseases such as unhealed wound, fracture, active gastric and duodenal ulcer, ulcerative colitis or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator;
- Patients with any severe and/or uncontrolled disease, including:
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- Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90mmHg);
- Unstable angina pectoris, myocardial infarction, ≥ Grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc≥480ms) within 6 months after the first administration;
- Active or uncontrolled serious infection (≥CTCAE 2);
- Known history of clinically significant liver disease, including viral hepatitis, and known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (>1×103 copies/mL or>500 IU/mL); Known hepatitis C virus (HCV) infection and HCV RNA positive (>1×1000 copies/mL or>100 IU/mL), or other decompensated liver disease, chronic hepatitis requiring antiviral therapy;
- HIV test positive;
- Diabetes mellitus poorly controlled (fasting blood glucose ≥CTCAE 2);
- Urine routine examination indicates urine protein ≥++, and 24-hour urine protein quantification is confirmed to be>1.0 g;
- According to the judgment of the investigator, the patient has other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring concomitant treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subject, or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Chunmeng Wang, M.D., +86 13679196170, cmwang1975@163.com
Wangjun Yan, M.D., +86 18121299399, yanwj@fudan.edu.cn
About this study
Official title: The Safety and Efficacy of Endostar Combined With Toripalimab as Postoperative Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma: A Prospective, Single-arm, Open-label, Phase II Clinical Study
The goal of this clinical trial is to evaluate the efficacy and safety of Endostar combined with Toripalimab in the adjuvant treatment of resectable stage III-oligometastatic stage IV melanoma, and to find effective biomarkers of efficacy based on tumor paraffin tissue specimens and peripheral blood.
The main questions it aims to answer are:
Read more
- The efficacy and safety of the combination treatment regimen;
- Finding suitable biomarkers can refine the patients with effective treatment
After a series of evaluation, if the participants meet the inclusion and exclusion criteria and are evaluated by the investigator, they will formally enter the study observation period and receive the following treatments Endostar: The dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration.
Toripalimab: 3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles).
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
- Being tested
- Endostar, Toripalimab
- Keywords
- Melanoma, Stage III-oligometastatic IV, Endostar, Toripalimab, Combination therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
The dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration.
ToripalimabDrug
3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Drug group | Experimental | Not described Receives: Drug: Endostar; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
recurrence-free survival
Measured: One year after the first intravenous drip
Secondary outcomes (2)
DMFS
Distant metastasis-free survival
Measured: One year after the first intravenous drip
OS
Overall survival
Measured: One year 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 posted18 Jun 2023
- Study start1 Apr 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage III Cutaneous Melanoma AJCC v8Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunmeng Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907512
- Sponsor's protocol ID
- 20009224-4-2304B
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Endostar Combined With Toripalimab as Postoperative Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma: A Prospective, Single-arm, Open-label, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05907512
- Acronym / sponsor ID
- 20009224-4-2304B
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
- Keywords
- Melanoma, Stage III-oligometastatic IV, Endostar, Toripalimab, Combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 18 Jun 2023 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of Endostar combined with Toripalimab in the adjuvant treatment of resectable stage III-oligometastatic stage IV melanoma, and to find effective biomarkers of efficacy based on tumor paraffin tissue specimens and peripheral blood.
The main questions it aims to answer are:
- The efficacy and safety of the combination treatment regimen;
- Finding suitable biomarkers can refine the patients with effective treatment
After a series of evaluation, if the participants meet the inclusion and exclusion criteria and are evaluated by the investigator, they will formally enter the study observation period and receive the following treatments Endostar: The dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration.
Toripalimab: 3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug group | Experimental | Drug: Endostar, Drug: Toripalimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 Age ≤ age ≤75 years old;
- ECOG performance status: 0 - 1 score;
- Patients with malignant melanoma confirmed by pathology and/or cytology, except mucosal malignant melanoma and uveal malignant melanoma;
- Patients who have not received anti-tumor therapy at the initial stage of treatment;
- 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;
Key exclusion criteria (14 listed)
- Patients with a history of allergic reactions to biological products;
- Patients with previous or concurrent malignancies within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Any active autoimmune disease or history of autoimmune disease (such as, but not limited to, Autoimmune hepatitis, interstitial pneumonia, enteritis, Vasculitis, nephritis; asthma in which the subject needs medical intervention with Bronchiectasis cannot be included); However, the following patients are allowed to be included: Vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;
- Patients who need to use immunosuppressants, or systemic or absorbable local hormone therapy to achieve immunosuppression (dose>10mg/day prednisone or other equivalent therapeutic hormone), and continue to use within 2 weeks after the first administration;
- Patients with any signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event ≥CTCAE Grade 3 within 4 weeks prior to the first dose; Or digestive tract diseases such as unhealed wound, fracture, active gastric and duodenal ulcer, ulcerative colitis or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator;
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 |
|---|---|---|
| EndostarThe dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration. | Drug | Drug group |
| Toripalimab3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles). | Drug | Drug group |
Primary outcome
RFS
Time frame: One year after the first intravenous drip
recurrence-free survival
2 secondary outcomes
DMFS
Time frame: One year after the first intravenous drip
OS
Time frame: One year 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 22 Jun 2023.
- 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.
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 Endostar and Toripalimab in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, 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 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 22 Jun 2023. 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 Chunmeng Wang, M.D. (+86 1387197 6170, cmwang1975@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS (time frame: One year after the first intravenous drip). 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 22 Jun 2023.