Melanoma (Skin Cancer)Phase 2TRIUMPH-AMNCT07501104
Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma
A Phase 2 study testing Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide in people with Melanoma (Skin Cancer), run by Shanghai Zhongshan Hospital.
Trial summary
This is a single-arm, open-label, single-center, Phase II exploratory clinical study evaluating the efficacy, safety, and tolerability of neoadjuvant pucotenlimab combined with lenvatinib and temozolomide in patients with resectable Stage IIB/III acral melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the study and voluntarily sign the informed consent form (ICF). (Note: Items 1 and 10 are similar, but both are translated here) Age ≥ 18 and ≤ 75 years old. Histologically or cytologically confirmed resectable Stage IIB-III melanoma. Have at least one measurable lesion according to RECIST 1.1 criteria. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Life expectancy of ≥ 6 months. No prior systemic drug therapy for melanoma.
- Adequate major organ function meeting the following criteria:
- Hematology (without blood transfusion or use of hematopoietic stimulating factors within 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L; Platelets (PLT) ≥ 100×10^9/L; White Blood Cell (WBC) count ≥ 3.0×10^9/L.
- Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (upper limit of normal) (for patients with liver metastasis, ≤ 5 × ULN); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (for patients with Gilbert's syndrome, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50 ml/min.
- 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%. Women of childbearing potential must agree to use acceptable methods of contraception (e.g., intrauterine device [IUD], oral contraceptives, or condoms) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male patients must agree to use acceptable methods of contraception during the study and for 6 months after the end of the study.
- Agree to and sign the study Informed Consent Form (ICF) before initiating any study-related procedures.
Who cannot join
- Prior treatment with immune checkpoint inhibitors (including but not limited to pembrolizumab, nivolumab) or lenvatinib.
- Received anti-cancer therapy within 28 days (or 5 times the half-life, whichever is shorter) prior to the first dose of study treatment, or received any investigational drug therapy within 30 days.
- Underwent major surgery, open biopsy, or experienced major trauma within 4 weeks prior to enrollment.
- Use of immunosuppressive medications within 14 days prior to the start of treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., daily dose of prednisolone ≤ 10 mg or equivalent physiological doses of other corticosteroids).
- Any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; except for subjects with vitiligo or asthma that completely resolved in childhood and currently do not require medical intervention, or a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant).
- INR > 1.5 or APTT > 1.5 × ULN. Currently poorly controlled hypertension, defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
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- Subjects with proteinuria > 1+ on urinalysis will undergo a 24-hour urine collection to quantitatively assess proteinuria; those with urine protein ≥ 1 g/24 hours will be ineligible.
- Any current disease or condition that affects drug absorption, or inability to take lenvatinib orally.
- Current digestive tract diseases such as active gastric/duodenal ulcers or ulcerative colitis, active bleeding from an unresected tumor, or other conditions judged by the investigator as likely to cause gastrointestinal bleeding or perforation.
- Evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks), or occurrence of thromboembolic events (including stroke and/or transient ischemic attack) within 12 months.
- Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class > 2 congestive heart failure; ventricular arrhythmias requiring medical treatment; LVEF < 50%.
- History of other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Active or poorly controlled severe infections (≥ CTCAE v5.0 Grade 2 infection). Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., HBV DNA positive (> 1×10^4 copies/mL or > 2000 IU/mL); known hepatitis C virus (HCV) infection with positive HCV RNA (> 1×10^3 copies/mL), or other hepatitis, cirrhosis] (excluding patients whose relevant test results returned to normal after prior antiviral treatment).
- Unstable or clinically symptomatic brain metastases. Persistent toxicities from any prior anti-tumor therapies that have not recovered to ≤ CTCAE v5.0 Grade 2, though patients with any grade of alopecia are permitted to participate.
- Pregnant (positive pregnancy test prior to administration) or breastfeeding women.
- Received brachytherapy (radioactive seed implantation) within 60 days prior to enrollment.
- Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion that the patient has a disease or condition unsuitable for the use of the study drug (e.g., seizures requiring treatment), or that would affect the interpretation of study results or place the patient at high risk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Single-Center, Phase II Exploratory Study of Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma（TRIUMPH-AM）
This is a single-arm, open-label, single-center, Phase II exploratory clinical study evaluating the efficacy, safety, and tolerability of neoadjuvant pucotenlimab combined with lenvatinib and temozolomide in patients with resectable Stage IIB/III acral melanoma.
After providing written informed consent, eligible subjects will receive neoadjuvant combination therapy consisting of pucotenlimab, lenvatinib, and temozolomide, with each treatment cycle lasting 3 weeks. Surgical resection will be performed after 3 cycles of treatment. Postoperative adjuvant therapy will be determined based on the pathological results of the surgical specimens. Subjects who do not achieve a major pathological response (MPR) will receive pucotenlimab maintenance therapy for a total of 1 year, while subjects who achieve an MPR will be exempt from adjuvant therapy.
Treatment will continue until the completion of adjuvant therapy, disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or discontinuation determined by the investigator, whichever occurs first.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Pucotenlimab+Lenvatinib+TemozolomideDrug
Pucotenlimab: Administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle.
Temozolomide: Administered orally at a dose of 200 mg/m^2 once daily on Days 1 to 5 of each 21-day cycle.
Lenvatinib: Administered orally once daily at a dose of 8 mg for patients weighing < 60 kg, or 12 mg for patients weighing ≥ 60 kg.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide | Experimental | Not described Receives: Drug: Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
Measured: Up to the time of surgery (assessed approximately 9-10 weeks after the start of neoadjuvant therapy)
Secondary outcomes (1)
Pathological Complete Response (pCR) Rate
Measured: Up to the time of surgery (assessed approximately 9 weeks after the start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501104
- Sponsor's protocol ID
- B2026-007R
- Acronym
- TRIUMPH-AM
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center, Phase II Exploratory Study of Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma（TRIUMPH-AM）
- ClinicalTrials.gov ID
- NCT07501104
- Acronym / sponsor ID
- TRIUMPH-AM / B2026-007R
- Conditions
- Melanoma (Skin Cancer)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 30 Mar 2026 (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 single-arm, open-label, single-center, Phase II exploratory clinical study evaluating the efficacy, safety, and tolerability of neoadjuvant pucotenlimab combined with lenvatinib and temozolomide in patients with resectable Stage IIB/III acral melanoma.
After providing written informed consent, eligible subjects will receive neoadjuvant combination therapy consisting of pucotenlimab, lenvatinib, and temozolomide, with each treatment cycle lasting 3 weeks. Surgical resection will be performed after 3 cycles of treatment. Postoperative adjuvant therapy will be determined based on the pathological results of the surgical specimens. Subjects who do not achieve a major pathological response (MPR) will receive pucotenlimab maintenance therapy for a total of 1 year, while subjects who achieve an MPR will be exempt from adjuvant therapy.
Treatment will continue until the completion of adjuvant therapy, disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or discontinuation determined by the investigator, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide | Experimental | Drug: Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand the study and voluntarily sign the informed consent form (ICF). (Note: Items 1 and 10 are similar, but both are translated here) Age ≥ 18 and ≤ 75 years old. Histologically or cytologically confirmed resectable Stage IIB-III melanoma. Have at least one measurable lesion according to RECIST 1.1 criteria. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Life expectancy of ≥ 6 months. No prior systemic drug therapy for melanoma.
- Hematology (without blood transfusion or use of hematopoietic stimulating factors within 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L; Platelets (PLT) ≥ 100×10^9/L; White Blood Cell (WBC) count ≥ 3.0×10^9/L.
- Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (upper limit of normal) (for patients with liver metastasis, ≤ 5 × ULN); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (for patients with Gilbert's syndrome, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50 ml/min.
- Coagulation: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and Prothrombin Time (PT) ≤ 1.5 × ULN.
Key exclusion criteria (17 listed)
- Prior treatment with immune checkpoint inhibitors (including but not limited to pembrolizumab, nivolumab) or lenvatinib.
- Received anti-cancer therapy within 28 days (or 5 times the half-life, whichever is shorter) prior to the first dose of study treatment, or received any investigational drug therapy within 30 days.
- Underwent major surgery, open biopsy, or experienced major trauma within 4 weeks prior to enrollment.
- Use of immunosuppressive medications within 14 days prior to the start of treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., daily dose of prednisolone ≤ 10 mg or equivalent physiological doses of other corticosteroids).
- Any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; except for subjects with vitiligo or asthma that completely resolved in childhood and currently do not require medical intervention, or a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant).
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 |
|---|---|---|
| Neoadjuvant Pucotenlimab+Lenvatinib+TemozolomidePucotenlimab: Administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle. Temozolomide: Administered orally at a dose of 200 mg/m^2 once daily on Days 1 to 5 of each 21-day cycle. Lenvatinib: Administered orally once daily at a dose of 8 mg for patients weighing < 60 kg, or 12 mg for patients weighing ≥ 60 kg. | Drug | Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: Up to the time of surgery (assessed approximately 9-10 weeks after the start of neoadjuvant therapy)
1 secondary outcome
Pathological Complete Response (pCR) Rate
Time frame: Up to the time of surgery (assessed approximately 9 weeks after the start of treatment)
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 30 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Pucotenlimab+Lenvatinib+Temozolomide in people with Melanoma (Skin Cancer), run by Shanghai Zhongshan Hospital.
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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Wei (+86 13681973586, wei.chuanyuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: Up to the time of surgery (assessed approximately 9-10 weeks after the start of neoadjuvant therapy)). 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 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.