Advanced Mucosal MelanomaPhase 2NCT06041724
Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma
A Phase 2 study testing Envafolimab combined with recombinant human endostatin and first-line chemotherapy in people with Advanced Mucosal Melanoma, run by Fudan University.
Trial summary
This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Mucosal Melanoma
- What is being tested?
- Envafolimab combined with recombinant human endostatin and first-line chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2023to 18 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of gender.
- Histology and pathology confirmed advanced mucosal melanoma.
- Gene mutation state is not limited, except BRAFV600 mutation.
- Has not received first-line treatment for advanced melanoma, and temozolomide and cisplatin have been used in the adjuvant therapy phase, except that the adjuvant therapy phase has been over 6 months or more.
- Eastern Cancer Cooperation Group (ECOG) physical condition score (PS) 0-1.
- The estimated survival time is more than 3 months.
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- Within 7 days before screening (including 7 days), the laboratory data were required as follows: neutrophil count ≥ 1.5 × 109 shock L, platelet count ≥ 90 × 109 shock L, hemoglobin ≥ 90g/L (no blood transfusion within 14 days), serum total bilirubin ≤ 1.25x normal upper limit (ULN), ALT and AST ≤ 2.5xULN (patients with liver metastasis ≤ 5xULN); serum creatinine ≤ 1.25xULN.
- Have at least one measurable focus (RECIST1.1 standard).
- Subjects (or their legal representatives / guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Who cannot join
- Patients who have previously used PD-L1 inhibitors, except those who progressed 1 year after the end of adjuvant therapy of PD-L1 monoclonal antibody;
- Allergic to Envafolimab or recombinant human endostatin and experimental chemotherapeutic drugs;
- Received any experimental drugs or antineoplastic drugs within 4 weeks before entering the group;
- There is a risk of bleeding, bleeding events of clinical significance or other taboos in the use of antivascular drugs;
- There is a history of other tumors in the past five years, except for cured cervical cancer or skin basal cell carcinoma;
- There are tumor emergencies that require immediate radiotherapy, such as symptomatic brain or meningeal metastasis, bone-related events, etc;
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- Pregnant or lactating women; Fertile women who do not use adequate contraception;
- Alcohol or drug addiction;
- Patients with active, or history of autoimmune diseases that may recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk (such as immunosuppressive therapy required for organ transplants). Except for autoimmune hypothyroidism that requires only hormone replacement therapy or skin diseases that do not require systemic treatment;
- Patients who need to receive systemic corticosteroids (dose equivalent to > 10mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study. The use of topical or inhaled corticosteroids, or short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune and infrequent allergic diseases;
- Important organ failure or other serious diseases, including interstitial pneumonia, clinically related coronary artery disease, cardiovascular disease or myocardial infarction, congestive heart failure, unstable angina pectoris, symptomatic pericardial effusion or unstable arrhythmia within 6 months before admission;
- A history of human immunodeficiency virus infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplant or stem cell transplantation;
- Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, stable hepatitis B (DNA titer ≤ 103copies / ml) and cured hepatitis C patients (HCVRNA negative) can be enrolled in the group;
- A history of severe neurological or psychiatric illness; severe infection; active disseminated intravascular coagulation or other concomitant diseases that, in the opinion of the researchers, seriously endanger the safety of patients or affect the completion of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single-arm II Phase Study of Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy
This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. At the same time, the tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, ctDNA and other biomarkers and the results were analyzed to find the predictive factors of prognosis or curative effect. Patients with advanced mucosal melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in this study and received 6 cycles of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin. Patients without progression were then maintained with Envafolimab combined with recombinant human endostatin until disease progression, intolerable adverse reactions, patient death or withdrawal of informed consent. The longest administration time of recombinant human endostatin was no more than 1 year, and that of Envafolimab was not more than 2 years. The efficacy was evaluated for the first time at 6 weeks, every 6 weeks for the following year, and then every 12 weeks until the end of progress or treatment. The examination method was consistent with the baseline; it was expected to be included in the group for 18 months, and clinical observation until disease progression and patient death.
- Conditions
- Advanced Mucosal Melanoma
- Being tested
- Envafolimab combined with recombinant human endostatin and first-line chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab combined with recombinant human endostatin and first-line chemotherapyDrug
Envafolimab: 300mg day1, s.c. Q3W; Recombinant human endostatin: 210mg day1, Intravenous pump for 72 hours, Q3W; Temozolomide: 150 mg/m2 d1-5, i.v. Q3W; Cisplatin: 25 mg/m2 d1-3, i.v. Q3W.
All of the above drugs were used for 6 cycles, and then Envafolimab and recombinant human endostatin continued only in patients with no progression in the first stage until disease progression as defined by RECIST1.1, unacceptable toxicity, withdrawal from the study or death, or no more than 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab combined with recombinant human endostatin and first-line chemotherapy | Experimental | Not described Receives: Drug: Envafolimab combined with recombinant human endostatin and first-line chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Measured: 12 months
Secondary outcomes (7)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable lesions achieving a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Measured: 12 months
Disease Control Rate (DCR)
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Measured: 12 months
Duration of Response (DoR)
The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Measured: 12 months
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: 12 months
PD-L1 expression from the tissue and peripheral blood samples of the patients
The tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, and the results were analyzed to find the predictive factors of prognosis or curative effect.
Measured: baseline (When entering the group)
ctDNA expression from the tissue and peripheral blood samples of the patients
The tissue and peripheral blood samples of the patients were taken for the determination of ctDNA expression, and the results were analyzed to find the predictive factors of prognosis or curative effect.
Measured: baseline (When entering the group)
Adverse Events (AEs) according to CTCAE v5.0.
Adverse Events (AEs) according to CTCAE v5.0.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start18 Sep 2023 (estimated)
- Primary completion18 Sep 2025 (estimated)
- Study completion18 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Mucosal MelanomaStudies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
- Investigators
- Zhiguo Luo, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041724
- Sponsor's protocol ID
- Fudan-MM003
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm II Phase Study of Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT06041724
- Acronym / sponsor ID
- Fudan-MM003
- Conditions
- Advanced Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (estimated)
- Primary completion
- 18 Sep 2025 (estimated)
- Study completion
- 18 Mar 2026 (estimated)
- First posted
- 18 Sep 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.
This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. At the same time, the tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, ctDNA and other biomarkers and the results were analyzed to find the predictive factors of prognosis or curative effect. Patients with advanced mucosal melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in this study and received 6 cycles of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin. Patients without progression were then maintained with Envafolimab combined with recombinant human endostatin until disease progression, intolerable adverse reactions, patient death or withdrawal of informed consent. The longest administration time of recombinant human endostatin was no more than 1 year, and that of Envafolimab was not more than 2 years. The efficacy was evaluated for the first time at 6 weeks, every 6 weeks for the following year, and then every 12 weeks until the end of progress or treatment. The examination method was consistent with the baseline; it was expected to be included in the group for 18 months, and clinical observation until disease progression and patient death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab combined with recombinant human endostatin and first-line chemotherapy | Experimental | Drug: Envafolimab combined with recombinant human endostatin and first-line chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old, regardless of gender.
- Histology and pathology confirmed advanced mucosal melanoma.
- Gene mutation state is not limited, except BRAFV600 mutation.
- Has not received first-line treatment for advanced melanoma, and temozolomide and cisplatin have been used in the adjuvant therapy phase, except that the adjuvant therapy phase has been over 6 months or more.
- Eastern Cancer Cooperation Group (ECOG) physical condition score (PS) 0-1.
Key exclusion criteria (14 listed)
- Patients who have previously used PD-L1 inhibitors, except those who progressed 1 year after the end of adjuvant therapy of PD-L1 monoclonal antibody;
- Allergic to Envafolimab or recombinant human endostatin and experimental chemotherapeutic drugs;
- Received any experimental drugs or antineoplastic drugs within 4 weeks before entering the group;
- There is a risk of bleeding, bleeding events of clinical significance or other taboos in the use of antivascular drugs;
- There is a history of other tumors in the past five years, except for cured cervical cancer or skin basal cell carcinoma;
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 |
|---|---|---|
| Envafolimab combined with recombinant human endostatin and first-line chemotherapyEnvafolimab: 300mg day1, s.c. Q3W; Recombinant human endostatin: 210mg day1, Intravenous pump for 72 hours, Q3W; Temozolomide: 150 mg/m2 d1-5, i.v. Q3W; Cisplatin: 25 mg/m2 d1-3, i.v. Q3W. All of the above drugs were used for 6 cycles, and then Envafolimab and recombinant human endostatin continued only in patients with no progression in the first stage until disease progression as defined by RECIST1.1, unacceptable toxicity, withdrawal from the study or death, or no more than 2 years. | Drug | Envafolimab combined with recombinant human endostatin and first-line chemotherapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: 12 months
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Duration of Response (DoR)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
PD-L1 expression from the tissue and peripheral blood samples of the patients
Time frame: baseline (When entering the group)
ctDNA expression from the tissue and peripheral blood samples of the patients
Time frame: baseline (When entering the group)
Adverse Events (AEs) according to CTCAE v5.0.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
Zhiguo Luo, M.D principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab combined with recombinant human endostatin and first-line chemotherapy in people with Advanced Mucosal Melanoma, run by Fudan University.
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 9 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 18 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiguo Luo, M.D (+8621-64175590 ext. 8908, luozhiguo88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 12 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 18 Sep 2023.