Trial Title:
Endostar Plus Toripalimab as Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma
NCT ID:
NCT05907512
Condition:
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Conditions: Official terms:
Melanoma
Melanoma, Cutaneous Malignant
Skin Neoplasms
Endostar protein
Conditions: Keywords:
Melanoma
Stage III-oligometastatic IV
Endostar
Toripalimab
Combination therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Endostar
Description:
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.
Arm group label:
Drug group
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
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).
Arm group label:
Drug group
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.
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18 Age ≤ age ≤75 years old;
2. ECOG performance status: 0 - 1 score;
3. Patients with malignant melanoma confirmed by pathology and/or cytology, except
mucosal malignant melanoma and uveal malignant melanoma;
4. Patients who have not received anti-tumor therapy at the initial stage of treatment;
5. 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;
6. Complete surgical resection within 13 weeks prior to enrollment;
7. Laboratory tests are required to meet:
1. 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;
2. 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;
3. Coagulation function: activated partial thromboplastin time (APTT),
international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
4. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
8. 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;
9. Patients voluntarily joined the study, signed informed consent, and had good
compliance and were able to be followed up by the trial staff.
Exclusion Criteria:
1. Patients with a history of allergic reactions to biological products;
2. 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);
3. 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;
4. 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;
5. 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;
6. Patients with any severe and/or uncontrolled disease, including:
1. Patients with poorly controlled blood pressure (systolic blood pressure ≥150
mmHg or diastolic blood pressure ≥90mmHg);
2. Unstable angina pectoris, myocardial infarction, ≥ Grade 2 congestive heart
failure, or arrhythmia requiring treatment (including QTc≥480ms) within 6
months after the first administration;
3. Active or uncontrolled serious infection (≥CTCAE 2);
4. 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;
5. HIV test positive;
6. Diabetes mellitus poorly controlled (fasting blood glucose ≥CTCAE 2);
7. Urine routine examination indicates urine protein ≥++, and 24-hour urine
protein quantification is confirmed to be>1.0 g;
7. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunmeng Wang, M.D.
Phone:
+86 13679196170
Email:
cmwang1975@163.com
Contact backup:
Last name:
Wangjun Yan, M.D.
Phone:
+86 18121299399
Email:
yanwj@fudan.edu.cn
Investigator:
Last name:
Chunmeng Wang, M.D.
Email:
Principal Investigator
Start date:
April 1, 2020
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907512
