Mucosal MelanomaPhase 2NCT07236528
Combination of Carilizumab, Apatinib, and Radiotherapy for Advanced Mucosal Melanoma
A Phase 2 study testing Carilizumab and Apatinib in people with Mucosal Melanoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- Carilizumab and 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 31 May 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, ≤ 80 years old, gender not limited
- Confirmed by pathological histology, patients with recurrent, unresectable, or metastatic mucosal melanoma after surgery
- In the late stage, no systemic anti-tumor drug treatment has been received, and previous radical surgical resection, adjuvant or neoadjuvant therapy is allowed. However, it is required to be completed at least 4 weeks before randomization, and all treatment-related toxicity events have returned to normal or CTCAE 5.0 grade I or below (except for hair loss, skin hypopigmentation, well controlled hypothyroidism, and adrenal insufficiency)
- There must be at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1 requirements, the length of the measurable lesion on spiral CT or MRI scan must be ≥ 10 mm or the length of enlarged lymph nodes must be ≥ 15 mm)
- At least one lesion that can receive radiotherapy
- ECOG PS 0 or 1 point
Show all 11Show fewer
- Expected survival period ≥ 12 weeks
- No contraindications for treatment, with sufficient organ and bone marrow function: ① Absolute neutrophil count ≥ 1.5 × 109/L ② Platelets ≥ 80 × 109/L③ Hemoglobin ≥ 90 g/L④ ALT and AST ≤ 1.5 × ULN⑤ Bilirubin ≤ 1.5 × ULN⑥ Blood creatinine ≤ 1.5 × ULN
- Patients may have a history of brain/meningeal metastases, but they must have undergone local treatment (surgery/radiation therapy) before the start of the study and have been clinically stable for at least 3 months (corticosteroids are allowed to be used before randomization, but must be discontinued 2 weeks before starting the study drug)
- Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 12 months after the end of the study treatment period
- For male patients whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 12 months after the last dose. 11. Participants voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up.
Who cannot join
- Patients who have received VEGFR TKI treatment within the past 6 months (including neoadjuvant and adjuvant treatment periods)
- Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components
- History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Previous thyroid dysfunction and inability to maintain normal thyroid function even with medication treatment
- Pregnant or lactating women
- Evidence of bleeding quality or significant coagulation dysfunction (not receiving anticoagulant therapy)
Show all 19Show fewer
- Bleeding events occurring within 6 months prior to the first medication due to untreated or incompletely treated esophageal and/or gastric varices
- Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months before the first use of medication
- Insufficient control of hypertension (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg) (based on the average of BP readings obtained from ≥ 2 measurements), allowing for the use of antihypertensive therapy to achieve the above parameters
- Previously experienced hypertensive crisis or hypertensive encephalopathy
- Within the past 3 months, there has been severe cardiovascular disease (such as New York Heart Association Grade II or above heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina pectoris
- Severe, unhealed, or cracked wounds, active ulcers, or untreated fractures
- Perform hollow needle biopsy or other minor surgery within 3 days before the first medication, excluding the placement of vascular access devices
- Major surgery should be performed within 4 weeks before the first medication, or expected to be required during the study period
- Those who have been treated with systemic immunosuppressive drugs (including but not limited to glucocorticoids [>10 mg/d prednisone or other corticosteroids with equivalent physiological doses], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha [TNF - α] preparations) within 2 weeks prior to their first medication, or who are expected to require systemic immunosuppressive drugs during the study treatment period
- Subjects who have received or will receive a live vaccine within 30 days prior to the first dose, or who are expected to use the vaccine during the expected treatment period or within 5 months after the last dose
- 176. Individuals known to be allergic to any investigational drug or excipient
- 18. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
- 19. Researchers determine other situations that are not suitable for inclusion in the study.
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 Prospective, Multicenter, Single Arm, Open Label Clinical Study Evaluating the Efficacy and Safety of the Combination of Carilizumab With Apatinib Mesylate and Radiotherapy in the First-line Treatment of Advanced Mucosal Melanoma
This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma.
Read the detailed description
This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma. The study will use the 6-month progression free survival rate (PFS6) as the primary efficacy indicator and plan to enroll approximately 30 non-surgical first-line treatment subjects with mucosal melanoma. After being fully informed and signing informed consent forms, the subjects will be screened and qualified to receive the following treatments: Induction phase (2 cycles): 200mg of Carilizumab, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Completed 2 cycles in total. ·Synchronous radiotherapy stage: 200mg of Carilizumab is administered intravenously once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; The radiation therapy plan evaluated by the researchers: the radiation dose and radiation field are determined by the researchers, with an overall principle of 18-25Gy/3-6f, or equivalent BED. Three dimensional conformal radiotherapy (3D-CRT) or intensity-modulated conformal radiotherapy (IMRT) techniques are used for radiotherapy. Radiotherapy should be scheduled before the use of PD-1 antibody Carilizumab, and intravenous infusion of Carilizumab should be administered within 48 hours after the end of radiotherapy. If there are multiple lesions that can be treated with radiotherapy, after evaluation by the research team, sequential radiotherapy for multiple lesions is allowed based on the lesion location and the tolerance of surrounding normal organs. ·Maintenance phase: Carilizumab 200mg, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Until tumor progression, intolerance, initiation of other anti-tumor treatments, loss to follow-up, or death. The cumulative maximum shall not exceed 2 years. After the completion of treatment, subjects will continue to undergo post-treatment safety and survival follow-up. For subjects who have completed treatment due to non disease progression/death reasons, tumor progression follow-up will also be conducted after the completion of treatment. Safety visit: After the subjects are enrolled in the study, safety visits will be conducted at each treatment cycle D1 and at the end of treatment visit. Imaging assessment: All lesions were recorded and evaluated according to RECIST 1.1. The window period allowed for imaging examinations is ± 7 days unless otherwise specified. During the research period, unplanned imaging examinations may be performed when tumor progression is suspected. The assessment of tumor baseline within 4 weeks before enrollment, CT/MRI scan results obtained before signing informed consent can be used for screening tumor assessment as long as they meet the requirements; Suspected brain metastases require enhanced MRI/CT of the brain to rule out brain metastases. When there is a clear or clinical suspicion of bone metastasis, bone scan examination should be performed to exclude bone metastasis. Within 12 months after the first administration, imaging examinations should be conducted every 2 cycles (± 7 days). After 12 months, imaging examinations should be conducted every 3 cycles (± 7 days). If there is suspicion of metastasis to other areas, additional imaging examinations for that area should be performed. After terminating the study treatment, subjects who did not show imaging progression continued to undergo imaging evaluation at the frequency of the treatment period until imaging progression, acceptance of other anti-tumor treatments, withdrawal of informed consent, loss to follow-up, or death occurred. Survival follow-up: After the completion or withdrawal of the study, survival and post study information will be collected through telephone follow-up every 3 months until death, loss to follow-up, withdrawal of informed consent, observation for 1 year, or termination of the study by the researcher.
- Conditions
- Mucosal Melanoma
- Being tested
- Carilizumab and Apatinib
- Keywords
- radiotherapy, Carilizumab, Apatinib Mesylate, Mucosal melanoma, first-line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carilizumab and ApatinibDrug
Carilizumab 200mg, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Completed 2 cycles in total. ·Synchronous radiotherapy stage: 200mg of Carilizumab is administered intravenously once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle;
| Study group | Role | What they receive |
|---|---|---|
| Combination of Carilizumab with Apatinib Mesylate and Radiotherapy | Experimental | Not described Receives: Drug: Carilizumab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression free survival rate
Measured: From the day each patient starts treatment until the 6th month (180 days).
Secondary outcomes (3)
Overall survival, OS
Measured: every 3 months after the patient completed the trial treatment
Disease control rate,DCR
Measured: The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
objective response rate
Measured: The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengyun Zou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236528
- Sponsor's protocol ID
- 2025-0433-01
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm, Open Label Clinical Study Evaluating the Efficacy and Safety of the Combination of Carilizumab With Apatinib Mesylate and Radiotherapy in the First-line Treatment of Advanced Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT07236528
- Acronym / sponsor ID
- 2025-0433-01
- Conditions
- Mucosal Melanoma
- Keywords
- radiotherapy, Carilizumab, Apatinib Mesylate, Mucosal melanoma, first-line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 19 Nov 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 study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma.
Detailed description
This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma. The study will use the 6-month progression free survival rate (PFS6) as the primary efficacy indicator and plan to enroll approximately 30 non-surgical first-line treatment subjects with mucosal melanoma. After being fully informed and signing informed consent forms, the subjects will be screened and qualified to receive the following treatments: Induction phase (2 cycles): 200mg of Carilizumab, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Completed 2 cycles in total. ·Synchronous radiotherapy stage: 200mg of Carilizumab is administered intravenously once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; The radiation therapy plan evaluated by the researchers: the radiation dose and radiation field are determined by the researchers, with an overall principle of 18-25Gy/3-6f, or equivalent BED. Three dimensional conformal radiotherapy (3D-CRT) or intensity-modulated conformal radiotherapy (IMRT) techniques are used for radiotherapy. Radiotherapy should be scheduled before the use of PD-1 antibody Carilizumab, and intravenous infusion of Carilizumab should be administered within 48 hours after the end of radiotherapy. If there are multiple lesions that can be treated with radiotherapy, after evaluation by the research team, sequential radiotherapy for multiple lesions is allowed based on the lesion location and the tolerance of surrounding normal organs. ·Maintenance phase: Carilizumab 200mg, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Until tumor progression, intolerance, initiation of other anti-tumor treatments, loss to follow-up, or death. The cumulative maximum shall not exceed 2 years. After the completion of treatment, subjects will continue to undergo post-treatment safety and survival follow-up. For subjects who have completed treatment due to non disease progression/death reasons, tumor progression follow-up will also be conducted after the completion of treatment. Safety visit: After the subjects are enrolled in the study, safety visits will be conducted at each treatment cycle D1 and at the end of treatment visit. Imaging assessment: All lesions were recorded and evaluated according to RECIST 1.1. The window period allowed for imaging examinations is ± 7 days unless otherwise specified. During the research period, unplanned imaging examinations may be performed when tumor progression is suspected. The assessment of tumor baseline within 4 weeks before enrollment, CT/MRI scan results obtained before signing informed consent can be used for screening tumor assessment as long as they meet the requirements; Suspected brain metastases require enhanced MRI/CT of the brain to rule out brain metastases. When there is a clear or clinical suspicion of bone metastasis, bone scan examination should be performed to exclude bone metastasis. Within 12 months after the first administration, imaging examinations should be conducted every 2 cycles (± 7 days). After 12 months, imaging examinations should be conducted every 3 cycles (± 7 days). If there is suspicion of metastasis to other areas, additional imaging examinations for that area should be performed. After terminating the study treatment, subjects who did not show imaging progression continued to undergo imaging evaluation at the frequency of the treatment period until imaging progression, acceptance of other anti-tumor treatments, withdrawal of informed consent, loss to follow-up, or death occurred. Survival follow-up: After the completion or withdrawal of the study, survival and post study information will be collected through telephone follow-up every 3 months until death, loss to follow-up, withdrawal of informed consent, observation for 1 year, or termination of the study by the researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Carilizumab with Apatinib Mesylate and Radiotherapy | Experimental | Drug: Carilizumab and Apatinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old, ≤ 80 years old, gender not limited
- Confirmed by pathological histology, patients with recurrent, unresectable, or metastatic mucosal melanoma after surgery
- In the late stage, no systemic anti-tumor drug treatment has been received, and previous radical surgical resection, adjuvant or neoadjuvant therapy is allowed. However, it is required to be completed at least 4 weeks before randomization, and all treatment-related toxicity events have returned to normal or CTCAE 5.0 grade I or below (except for hair loss, skin hypopigmentation, well controlled hypothyroidism, and adrenal insufficiency)
- There must be at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1 requirements, the length of the measurable lesion on spiral CT or MRI scan must be ≥ 10 mm or the length of enlarged lymph nodes must be ≥ 15 mm)
- At least one lesion that can receive radiotherapy
Key exclusion criteria (19 listed)
- Patients who have received VEGFR TKI treatment within the past 6 months (including neoadjuvant and adjuvant treatment periods)
- Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components
- History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Previous thyroid dysfunction and inability to maintain normal thyroid function even with medication treatment
- Pregnant or lactating women
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 |
|---|---|---|
| Carilizumab and ApatinibCarilizumab 200mg, intravenous infusion, administered once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; Completed 2 cycles in total. ·Synchronous radiotherapy stage: 200mg of Carilizumab is administered intravenously once every 2 weeks, with a 4-week cycle; Apatinib mesylate 500mg, oral, once daily, adjusted according to patient tolerance, with a 4-week cycle; | Drug | Combination of Carilizumab with Apatinib Mesylate and Radiotherapy |
Primary outcome
6-month progression free survival rate
Time frame: From the day each patient starts treatment until the 6th month (180 days).
3 secondary outcomes
Overall survival, OS
Time frame: every 3 months after the patient completed the trial treatment
Disease control rate,DCR
Time frame: The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
objective response rate
Time frame: The subjects must be confirmed at least 4 weeks ± 7 days after the initial evaluation.
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 19 Nov 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carilizumab and Apatinib in people with Mucosal Melanoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 11 inclusion and 19 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 19 Nov 2025. 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 Zou Zhengyun (+8613815891858, zouzhengyun@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression free survival rate (time frame: From the day each patient starts treatment until the 6th month (180 days).). 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 19 Nov 2025.