Mucosal MelanomaPhase 2NCT04180995
Toripalimab in Combination With Axitinib in Patients With Localized Mucosal Melanoma
A Phase 2 study testing TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®) in people with Mucosal Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is one monocentric, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab monoclonal injection (Tuo Yi) combined with axitinib tablet (Inlyta®) as neoadjuvant therapy for localized mucosal melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)
- 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
- 1 siteChina
- Study dates
- 6 Aug 2019to 30 Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being voluntary to sign the informed consent form, with good compliance and willingness to cooperate with follow-up;
- Age of 18-75 years, male or female;
- Histopathologically diagnosed mucosal melanoma;
- ECOG PS score 0 or 1;
- Being considered to be able to be completely resected after multidisciplinary (including surgeon, oncologist and radiologist) discussion, and systemic staging examination improved prior to enrollment (need to include cranial enhanced CT/MRI, bone scan, thoracic, abdominal and pelvic enhanced CT/MRI (enhanced MRI of head and neck, gynecological examination additionally needed for female genital melanoma, colonoscopy additionally needed for rectal melanoma), B mode ultrasonography of superficial lymph node, or systemic PET-CT) demonstrated no regional or distant metastasis;
- No contraindications for the treatment, including normal peripheral hemogram, basically normal hepatic and renal function as well as ECG:
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- Peripheral hemogram: white blood cell (WBC) ≥3.5×109/L, neutrophil (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hgb) ≥90 g/L;
- Liver function: alanine aminotransferase (ALT) ≤1.5×ULN, aspartate aminotransferase (AST) ≤1.5×ULN, and total bilirubin (TBil) ≤1.5×ULN;
- Renal function: blood urea nitrogen ≤ ULN, creatinine ≤ ULN;
- Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of pregnant possibility (e.g. oral contraceptives, intrauterine contraceptive device, abstinence of sexual intercourse or barrier contraception in combination with spermatocide), and continuation of contraception for 12 months after the end of study treatment.
Who cannot join
- Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, or antiangiogenic drugs;
- Known allergy to Toripalimab or Axitinib or excipient of the study drug;
- Patients with ocular melanoma or melanoma with unknown primary foci;
- Pregnant and breastfeeding women;
- Abnormal coagulation function [activated partial thromboplastin time (APTT)> 43 s, or international normalized ratio (INR) > 1.5×ULN], or hemorrhagic tendency or hemorrhagic event occurred within two months prior to enrollment (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, etc.), or receiving thrombolytic or anticoagulation therapy;
- Currently having serious and uncontrolled acute infection, or suppurative infection, chronic infection, or prolonged wound healing;
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- Having serious heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular heart disease and refractory hypertension;
- Having neurological, mental disease or psychiatric disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Concomitantly other Malignancies;
- Concomitant participation in other clinical trials;
- Positive HIV antibody, or positive HCV antibody/HCV-RNA, or positive HBsAg or HBcAb whilst HBV DNA copy >2000 IU/ml;
- Active autoimmune diseases requiring systemic treatment in the past two years (e.g., use of disease-regulating drug, corticosteroid or immunosuppressant), relevant replacement therapy is allowed (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency);
- Vaccination of live vaccine within 4 weeks prior to the start of study;
- Other severe, acute or chronic medical diseases or abnormalities in laboratory examination possibly increasing the relevant risk in study participation or possibly interfering the interpretation of study results as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: A Monocentric, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Localized Mucosal Melanoma
This study is one monocentric, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab monoclonal injection (Tuo Yi) combined with axitinib tablet (Inlyta®) as neoadjuvant therapy for localized mucosal melanoma.
Primary objective: To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation.
- Conditions
- Mucosal Melanoma
- Being tested
- TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)Drug
TORIPALIMAB INJECTION(JS001 ) combined with chemotherapy, 3mg/kg, Q2W,up to 1 years of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab, Axitinib | Experimental | The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation. Receives: Drug: TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response (pCR+pPR) rate: defined as the percentage of subjects without alive tumor cells and alive tumor cells in postoperative resected specimens 10% - 50% in the resected specimen post operation.
To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
Measured: Approximately 8 weeks
Secondary outcomes (4)
RFS (recurrence-free survival) per RECIST1.1 as Assessed by investigator
To evaluate recurrence-free survival (RFS) of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
Measured: Approximately 1 years
OS (overall survival)
OS at 1 or 2 years.
Measured: Approximately 2 years
Incidence of AEs/SAEs
Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0
Measured: Approximately 2 years
Pathological complete response (pCR) rate: defined as the percentage of subjects without alive tumor cells in the resected specimen post operation.
To evaluate pathological complete response (pCR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
Measured: Approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start6 Aug 2019
- Primary completion6 Jul 2022 (estimated)
- Study completion30 Dec 2022 (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 Peking University Cancer Hospital & InstituteThe 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
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180995
- Sponsor's protocol ID
- JS001-ISS-132
- Status last verified
- Jan 2022
- First submitted
- 26 Nov 2019
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Localized Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT04180995
- Acronym / sponsor ID
- JS001-ISS-132
- Conditions
- Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 6 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Nov 2019 (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 one monocentric, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab monoclonal injection (Tuo Yi) combined with axitinib tablet (Inlyta®) as neoadjuvant therapy for localized mucosal melanoma.
Primary objective: To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab, Axitinib | Experimental | Drug: TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being voluntary to sign the informed consent form, with good compliance and willingness to cooperate with follow-up;
- Age of 18-75 years, male or female;
- Histopathologically diagnosed mucosal melanoma;
- ECOG PS score 0 or 1;
- Being considered to be able to be completely resected after multidisciplinary (including surgeon, oncologist and radiologist) discussion, and systemic staging examination improved prior to enrollment (need to include cranial enhanced CT/MRI, bone scan, thoracic, abdominal and pelvic enhanced CT/MRI (enhanced MRI of head and neck, gynecological examination additionally needed for female genital melanoma, colonoscopy additionally needed for rectal melanoma), B mode ultrasonography of superficial lymph node, or systemic PET-CT) demonstrated no regional or distant metastasis;
Key exclusion criteria (15 listed)
- Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, or antiangiogenic drugs;
- Known allergy to Toripalimab or Axitinib or excipient of the study drug;
- Patients with ocular melanoma or melanoma with unknown primary foci;
- Pregnant and breastfeeding women;
- Abnormal coagulation function [activated partial thromboplastin time (APTT)> 43 s, or international normalized ratio (INR) > 1.5×ULN], or hemorrhagic tendency or hemorrhagic event occurred within two months prior to enrollment (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, etc.), or receiving thrombolytic or anticoagulation therapy;
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 |
|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)TORIPALIMAB INJECTION(JS001 ) combined with chemotherapy, 3mg/kg, Q2W,up to 1 years of treatment. | Drug | Toripalimab, Axitinib |
Primary outcome
Pathological response (pCR+pPR) rate: defined as the percentage of subjects without alive tumor cells and alive tumor cells in postoperative resected specimens 10% - 50% in the resected specimen post operation.
Time frame: Approximately 8 weeks
To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
4 secondary outcomes
RFS (recurrence-free survival) per RECIST1.1 as Assessed by investigator
Time frame: Approximately 1 years
OS (overall survival)
Time frame: Approximately 2 years
Incidence of AEs/SAEs
Time frame: Approximately 2 years
Pathological complete response (pCR) rate: defined as the percentage of subjects without alive tumor cells in the resected specimen post operation.
Time frame: Approximately 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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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.
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 TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®) in people with Mucosal Melanoma, run by Peking University Cancer Hospital & Institute 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 10 inclusion and 15 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 31 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanliang Cui, Dr ('+8613691489319, 1008ccl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response (pCR+pPR) rate: defined as the percentage of subjects without alive tumor cells and alive tumor cells in postoperative resected specimens 10% - 50% in the resected specimen post operation. (time frame: Approximately 8 weeks). 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 31 Jan 2022.