Acral MelanomaPhase 2NCT04331093
Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma
A Phase 2 study testing SHR-1210+Apatinib in people with Acral Melanoma, run by Di Wu at 1 site in China.
Trial summary
Acral melanoma is a melanoma that affects acral areas of the skin, which is the most prevalent site of melanoma in non-Caucasians.Data in this subgroup is scarce.This study is to evalueate the efficiency and safety of Neoadjuvant SHR-1210 plus apatinib in this particular group,menawhile to determine the predictive… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acral Melanoma
- What is being tested?
- SHR-1210+Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to Dec 2026
- 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
- 1.18 to 75 years. 2. Clinically diagnosed or pathologically diagnosed, resectable stage III-IV Acral melanoma with at least one measurable lesion that has not been treated locally (according to RECISTv1.1, this measurable lesion is spiral CT (Or MRI scan with a long diameter ≥10mm or an enlarged lymph node with a short diameter ≥15mm), patients with metastasis can also be enrolled; 3. Have not received any anti-tumor medication before. 4. ECOG score is 0 or 1. 5. Tumor tissue specimens must be provided for genetic testing (preoperative biopsy / intraoperative tissue removal).
- 6. Expected survival time ≥ 12 weeks. 7. The level of organ function must meet the following requirements (7 days before randomization):
- Peripheral blood: absolute neutrophil count (≥) 1.5 × 109 / L, platelet count (≥) 100 × 109 // L, hemoglobin (Hb) ≥9g / dL (no blood transfusion within 14 days before detection);
- Liver: serum total bilirubin (≤) 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or AST, ALT ≤ 5 × ULN);
- Serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50mL / min (using Cockcroft-Gault formula); ④. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (only applicable to patients who have not received anticoagulant therapy and received anticoagulant therapy, and anticoagulant drugs should meet the treatment requirements);
- ⑤. Cardiac function is normal, that is, the result of ECG is normal or has no clinical significance. Left ventricular ejection fraction (LVEF) of cardiac ultrasound examination is> 50%.
- 8. Women of childbearing age must have a negative pregnancy test within 7 days before treatment; males of reproductive capacity or women who are at risk of pregnancy must use effective contraception throughout the study period and continue contraception for 3 months after the end of treatment.
- 9. Can swallow pills normally. 10. Voluntarily participate in the research and sign the informed consent form, with good compliance and willingness to cooperate with the follow-up.
Who cannot join
- Patients who have been treated with anti-PD-1, anti-PD-L1, VEGFRTKI;
- Patients who are participating or are participating in clinical studies of other drugs or treatments, within 4 weeks before enrollment (prior to randomization);
- Patients who received major surgery, vaccines, and systemic hormone therapy within 4 weeks before the study began; and patients who received radiation therapy within 2 weeks;
- In the past 3 years, other malignancies other than acral or mucosal melanoma, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer and cervical cancer;
- Receive hematopoietic stimulating factors (such as granulocyte colony stimulating factor (G-CSF) and erythropoietin) within 1 week before the start of the study.
- HIV positive test;
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- Patients with active hepatitis B or C:
- ①. In the case of HBsAg or HBcAb positive, additional HBVDNA testing (results above the lower limit of detection specified by the study site).
- ②. In the case of HCV antibody positive, perform additional HCVRNA detection.
- Urine routine indicates urinary protein ≥ ++ and it has been confirmed that the amount of urinary protein in 24 hours is> 1.0g;
- Suffering from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Pleural effusion or ascites with clinical symptoms and symptomatic treatment;
- People with ocular shape and central nervous system (CNS) metastasis;
- Have a history of active tuberculosis;
- Have any uncontrollable clinical problems, including but not limited to:
- ①. Have autoimmune disease, or have a history of autoimmune disease or a syndrome requiring systemic treatment with steroids / immunosuppressants, such as pituitary inflammation, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism and thyroid Hypofunction
- ②. The following occurred within the first 6 months of randomization: 1) deep vein thrombosis or pulmonary embolism; 2) percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; 3) cerebrovascular accident, Transient ischemic attack.
- ③. Other serious and uncontrolled companion diseases that may affect the compliance of the agreement or the interpretation of the results, including active opportunistic or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (graded by the New York Heart Association) System-defined grade III or IV heart failure, grade II heart block, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction in the past three months, etc.). Or lung disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm);
- Patients with any condition that affects swallowing the drug, and any condition that affects the absorption of the research product in vivo, including any type of gastrointestinal resection or surgery;
- Previous stem cell transplant or organ transplant;
- Women with childbearing potential or pregnant or lactating women with a positive serum or urine pregnancy test within 7 days before the start of treatment;
- Previously addicted to antipsychotic drugs, cannot be quit, or have a history of mental illness;
- Other serious, acute or chronic medical conditions or laboratory abnormalities may increase the risks associated with participating in the research or may interfere with the interpretation of the research results by investigators;
- Other conditions that the researchers consider to be non-compliant or not applicable to participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Di Wu, MD, 13944888991 ext. 13944888991, Wudi991202@163.com
About this study
Official title: A Single-cencer,Phase II Study of Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma
Acral melanoma is a melanoma that affects acral areas of the skin, which is the most prevalent site of melanoma in non-Caucasians.Data in this subgroup is scarce.This study is to evalueate the efficiency and safety of Neoadjuvant SHR-1210 plus apatinib in this particular group,menawhile to determine the predictive value for efficiency of several biomarkers.
Read the detailed description
SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).
- Conditions
- Acral Melanoma
- Being tested
- SHR-1210+Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210+ApatinibDrug
Drug: SHR-1210 SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
Drug: Apatinib Apatinib tablet will be administered orally,once daily until progression
| Study group | Role | What they receive |
|---|---|---|
| resectable stage III-IV Acral melanoma | Experimental | Not described Receives: Drug: SHR-1210+Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological complete response rate
Measured: 3 months
Secondary outcomes (3)
npCR
Near pathological complete response rate
Measured: 3 months
ORR
Objective response rate
Measured: 3 months
3 Year RFS
Recurrence free survival in 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Mar 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acral MelanomaStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Di Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Di Wu, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331093
- Sponsor's protocol ID
- k2020033
- Status last verified
- May 2021
- First submitted
- 31 Mar 2020
- Last updated
- 26 May 2021
- 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 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-cencer,Phase II Study of Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma
- ClinicalTrials.gov ID
- NCT04331093
- Acronym / sponsor ID
- k2020033
- Conditions
- Acral Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Di WuUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Apr 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.
Acral melanoma is a melanoma that affects acral areas of the skin, which is the most prevalent site of melanoma in non-Caucasians.Data in this subgroup is scarce.This study is to evalueate the efficiency and safety of Neoadjuvant SHR-1210 plus apatinib in this particular group,menawhile to determine the predictive value for efficiency of several biomarkers.
Detailed description
SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| resectable stage III-IV Acral melanoma | Experimental | Drug: SHR-1210+Apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.18 to 75 years. 2. Clinically diagnosed or pathologically diagnosed, resectable stage III-IV Acral melanoma with at least one measurable lesion that has not been treated locally (according to RECISTv1.1, this measurable lesion is spiral CT (Or MRI scan with a long diameter ≥10mm or an enlarged lymph node with a short diameter ≥15mm), patients with metastasis can also be enrolled; 3. Have not received any anti-tumor medication before. 4. ECOG score is 0 or 1. 5. Tumor tissue specimens must be provided for genetic testing (preoperative biopsy / intraoperative tissue removal).
- 6. Expected survival time ≥ 12 weeks. 7. The level of organ function must meet the following requirements (7 days before randomization):
- Peripheral blood: absolute neutrophil count (≥) 1.5 × 109 / L, platelet count (≥) 100 × 109 // L, hemoglobin (Hb) ≥9g / dL (no blood transfusion within 14 days before detection);
- ⑤. Cardiac function is normal, that is, the result of ECG is normal or has no clinical significance. Left ventricular ejection fraction (LVEF) of cardiac ultrasound examination is> 50%.
- 8. Women of childbearing age must have a negative pregnancy test within 7 days before treatment; males of reproductive capacity or women who are at risk of pregnancy must use effective contraception throughout the study period and continue contraception for 3 months after the end of treatment.
Key exclusion criteria (24 listed)
- Patients who have been treated with anti-PD-1, anti-PD-L1, VEGFRTKI;
- Patients who are participating or are participating in clinical studies of other drugs or treatments, within 4 weeks before enrollment (prior to randomization);
- Patients who received major surgery, vaccines, and systemic hormone therapy within 4 weeks before the study began; and patients who received radiation therapy within 2 weeks;
- In the past 3 years, other malignancies other than acral or mucosal melanoma, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer and cervical cancer;
- Receive hematopoietic stimulating factors (such as granulocyte colony stimulating factor (G-CSF) and erythropoietin) within 1 week before the start of the study.
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 |
|---|---|---|
| SHR-1210+ApatinibDrug: SHR-1210 SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg Drug: Apatinib Apatinib tablet will be administered orally,once daily until progression | Drug | resectable stage III-IV Acral melanoma |
Primary outcome
pCR
Time frame: 3 months
Pathological complete response rate
3 secondary outcomes
npCR
Time frame: 3 months
ORR
Time frame: 3 months
3 Year RFS
Time frame: 3 years
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 26 May 2021.
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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.
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 SHR-1210+Apatinib in people with Acral Melanoma, run by Di Wu 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 8 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: looking for participants now, as of the sponsor's last update on 26 May 2021. 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?
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 Di Wu, MD (13944888991 ext. 13944888991, Wudi991202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: 3 months). 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 26 May 2021.