Melanoma of SkinPhase 2FUMS-EDJS2024NCT06965231
Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
A Phase 2 study testing Toripalimab combined with Endostar in people with Melanoma of Skin and Acral Melanoma, run by Fudan University at 4 sites in China.
Trial summary
This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma of Skin, Acral Melanoma, Stage II Melanoma
- What is being tested?
- Toripalimab combined with Endostar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2025to 30 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years, regardless of gender;
- ECOG performance status: 0-1;
- Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
- Patients with BRAF, CKIT, and NRAS gene test results;
- Treatment-naïve patients who have not received prior anti-tumor therapy;
- Clinical stage II (AJCC 8th edition, 2017);
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- Laboratory tests must meet the following criteria:
- Hematology: Hemoglobin (Hb) ≥90 g/L (no transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count (PLT) ≥100×10^9/L;
- Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance >50 μmol/L;
- Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN;
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;
- Female patients must agree to use contraception (e.g., intrauterine device [IUD], oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative serum or urine pregnancy test within 7 days before enrollment is required, and patients must be non-lactating. Male patients must agree to use contraception during the study and for 6 months after study completion;
- Patients must voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
Who cannot join
- History of allergic reactions to biological products;
- Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);
- Any active autoimmune disease or history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilators for medical intervention). Exceptions include: vitiligo, psoriasis, alopecia not requiring systemic therapy, well-controlled type I diabetes, or hypothyroidism with normal thyroid function on replacement therapy;
- Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone >10mg/day) within 2 weeks prior to first dose;
- Any history or evidence of bleeding diathesis regardless of severity; grade ≥3 bleeding events per CTCAE v5.0 within 4 weeks prior to first dose; or presence of unhealed wounds, fractures, active gastrointestinal ulcers, ulcerative colitis, tumors with active bleeding, or other conditions deemed by investigators to potentially cause gastrointestinal hemorrhage or perforation;
- Patients with severe and/or uncontrolled comorbidities including:
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- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg);
- Unstable angina, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc ≥480ms) within 6 months prior to first dose;
- Active or uncontrolled severe infections (≥grade 2 per CTCAE);
- Clinically significant liver disease including viral hepatitis (active HBV infection with HBV DNA >1×10³ copies/mL or >500 IU/mL; HCV infection with HCV RNA >1×10³ copies/mL or >100 IU/mL), decompensated liver disease, or chronic hepatitis requiring antiviral therapy;
- HIV-positive status;
- Poorly controlled diabetes (fasting glucose ≥grade 2 per CTCAE);
- Urinalysis showing proteinuria ≥++ with 24-hour urinary protein >1.0 g;
- Administration of live vaccines within 4 weeks prior to treatment or anticipated need during study;
- Other conditions deemed by investigators to potentially lead to premature study termination, including: severe comorbidities (including psychiatric disorders) requiring concomitant therapy, significant laboratory abnormalities, or social/family factors that may compromise patient safety or data/sample collection.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Chunmeng Wang, Dr., +86 13671976170, cmwang1975@163.com
- Recruiting
Cancer center, Shanghai 411 hospital, China RongTong Medical Healthcare Group Co.Ltd./411 Hospital, Shanghai University
Shanghai, Shanghai Municipality, 200081
Xiaolan Yin, Dr., +86 13917419783, yxlorchid@163.com
- Recruiting
Department of Surgical Oncology, Fudan University Shanghai Cancer Center Minhang Branch Hospital
Shanghai, Shanghai Municipality, 200240
Hongqiang Zhang, Dr., +86 18918096892, 5251545@qq.com
- Recruiting
Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Jianjun Zhang, Dr., +86 18930172901, robustzhang168@aliyun.com
About this study
Official title: Efficacy and Safety of Perioperative Toripalimab Combined With Recombinant Human Endostatin as Postoperative Adjuvant Therapy for Clinical Stage II Malignant Melanoma: A Multicenter, Single-Arm, Phase II Clinical Study
This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer:
- Does this combination improve the 2-year recurrence-free survival (2y-RFS) compared to historical data?
- Is the treatment safe and tolerable for patients?
Read more
Participants will:
- Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy).
- Undergo surgical removal of the tumor.
- Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab).
- Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment.
This is a single-arm, multicenter study involving 58 patients across several hospitals in China. Results will help determine if this combination could become a new standard adjuvant therapy for stage II melanoma.
- Conditions
- Melanoma of Skin, Acral Melanoma, Stage II Melanoma
- Being tested
- Toripalimab combined with Endostar
- Keywords
- Melanoma of skin, Acral melanoma, Stage II melanoma, Toripalimab, Recombinant human endostatin (Endostar), Perioperative immunotherapy, PD-1 inhibitor, Anti-angiogenic therapy, Phase II study
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab combined with EndostarDrug
- Neoadjuvant Phase: 2 doses of toripalimab (240 mg IV, Q2W) before surgery.
- Surgery: Tumor resection within 2 weeks after the last neoadjuvant dose.
- Adjuvant Phase: 1) Toripalimab: 240 mg IV every 2 weeks (up to 11 cycles); 2) Endostar: 210 mg (72-hour continuous IV infusion) every 4 weeks (up to 6 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will:
1. Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy).
2. Undergo surgical removal of the tumor.
3. Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab).
4. Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment. Receives: Drug: Toripalimab combined with Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival rate (2-year RFS rate)
Measured: From enrollment to the end of the 2nd year of follow-up
Secondary outcomes (4)
1-year distant metastasis-free survival rate (1-year DMFS rate)
Measured: From enrollment to the end of the 1st year
Overall survival (OS)
Measured: Through study completion, an average of 3 years
1-year recurrence-free survival rate (1-year RFS rate)
Measured: From enrollment to the end of the 1st year
2-year distant metastasis-free survival rate (2-year DMFS rate)
Measured: From enrollment to the end of the 2nd year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma of SkinStudies 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Shanghai 411 hospital
- Responsible party
- Principal investigator, Chunmeng Wang, Fudan University
- Investigators
- Chunmeng Wang, Dr., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965231
- Sponsor's protocol ID
- IRB2501312-12
- Acronym
- FUMS-EDJS2024
- Status last verified
- May 2025
- First submitted
- 18 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Perioperative Toripalimab Combined With Recombinant Human Endostatin as Postoperative Adjuvant Therapy for Clinical Stage II Malignant Melanoma: A Multicenter, Single-Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06965231
- Acronym / sponsor ID
- FUMS-EDJS2024 / IRB2501312-12
- Conditions
- Melanoma of Skin, Acral Melanoma, Stage II Melanoma
- Keywords
- Melanoma of skin, Acral melanoma, Stage II melanoma, Toripalimab, Recombinant human endostatin (Endostar), Perioperative immunotherapy, PD-1 inhibitor, Anti-angiogenic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Shanghai 411 hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 11 May 2025 (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.
This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer:
- Does this combination improve the 2-year recurrence-free survival (2y-RFS) compared to historical data?
- Is the treatment safe and tolerable for patients?
Participants will:
- Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy).
- Undergo surgical removal of the tumor.
- Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab).
- Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment.
This is a single-arm, multicenter study involving 58 patients across several hospitals in China. Results will help determine if this combination could become a new standard adjuvant therapy for stage II melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Toripalimab combined with EndostarParticipants will: 1. Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy). 2. Undergo surgical removal of the tumor. 3. Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab). 4. Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years, regardless of gender;
- ECOG performance status: 0-1;
- Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
- Patients with BRAF, CKIT, and NRAS gene test results;
- Treatment-naïve patients who have not received prior anti-tumor therapy;
Key exclusion criteria (15 listed)
- History of allergic reactions to biological products;
- Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);
- Any active autoimmune disease or history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilators for medical intervention). Exceptions include: vitiligo, psoriasis, alopecia not requiring systemic therapy, well-controlled type I diabetes, or hypothyroidism with normal thyroid function on replacement therapy;
- Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone >10mg/day) within 2 weeks prior to first dose;
- Any history or evidence of bleeding diathesis regardless of severity; grade ≥3 bleeding events per CTCAE v5.0 within 4 weeks prior to first dose; or presence of unhealed wounds, fractures, active gastrointestinal ulcers, ulcerative colitis, tumors with active bleeding, or other conditions deemed by investigators to potentially cause gastrointestinal hemorrhage or perforation;
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 |
|---|---|---|
| Toripalimab combined with Endostar1. Neoadjuvant Phase: 2 doses of toripalimab (240 mg IV, Q2W) before surgery. 2. Surgery: Tumor resection within 2 weeks after the last neoadjuvant dose. 3. Adjuvant Phase: 1) Toripalimab: 240 mg IV every 2 weeks (up to 11 cycles); 2) Endostar: 210 mg (72-hour continuous IV infusion) every 4 weeks (up to 6 cycles). | Drug | Treatment Arm |
Primary outcome
2-year recurrence-free survival rate (2-year RFS rate)
Time frame: From enrollment to the end of the 2nd year of follow-up
4 secondary outcomes
1-year distant metastasis-free survival rate (1-year DMFS rate)
Time frame: From enrollment to the end of the 1st year
Overall survival (OS)
Time frame: Through study completion, an average of 3 years
1-year recurrence-free survival rate (1-year RFS rate)
Time frame: From enrollment to the end of the 1st year
2-year distant metastasis-free survival rate (2-year DMFS rate)
Time frame: From enrollment to the end of the 2nd year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided. Undecided yet.
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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.
Chunmeng Wang, Dr. principal investigator
Fudan University
4 sites 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 combined with Endostar in people with Melanoma of Skin and Acral Melanoma, run by Fudan University at 4 sites 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: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunmeng Wang, Dr. (+86 13671976170, cmwang1975@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival rate (2-year RFS rate) (time frame: From enrollment to the end of the 2nd year of follow-up). 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 11 May 2025.