Mucosal MelanomaPhase 2MTAMNCT04472806
Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
A Phase 2 study testing Toripalimab and chemotherapy in combination with Endostar in people with Mucosal Melanoma, run by Fudan University at 1 site in China.
Trial summary
This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic 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 and chemotherapy in combination with Endostar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2020to 20 Jun 2023
- 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
- Age 18-75 years, male or female；
- Histopathologically confirmed and diagnosed as mucosal melanoma;
- ECOG score 0 or 1;
- Life expectancy of at least 12 weeks；
- SD/PR/CR after chemotherapy in combination with Endostar;
- No contraindications, having adequate organ and marrow function；
- Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of childbearing potential (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 treatment；
- The subject is voluntary to participate in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up.
Who cannot join
- Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2;
- Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;
- Skin melanoma, eye melanoma, melanoma with unknown primary foci;
- Symptomatic brain or meningeal metastases, unless the patient has been treated for > 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study;
- Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures;
- Currently having serious and uncontrolled acute infection; or suppurative infection and chronic infection with prolonged wound healing;
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- Having serious heart disorder, including cardiac failure congestive, uncontrollable high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac valve disease and refractory hypertension;
- Having neurological, mental disease or mental disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;
- Patients with other malignant tumors at the same time;
- Patients participated in other clinical trials at the same time;
- Positive HIV; positive HCV; positive HBsAg or HBcAb whilst positive HBV DNA copies detected (limit of quantitation 500 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);
- Having received live vaccine within 4 weeks prior to the start of treatment;
- Other severe, acute or chronic medical diseases or mental 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
Zhiguo Luo
Shanghai, Shanghai Municipality, 200032
Zhiguo Luo, MD,PhD, 862164175590 ext. 8908, luozhiguo88@163.com
About this study
Official title: A Multicenter, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab(JS001) After Chemotherapy in Combination With Endostar in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.
- Conditions
- Mucosal Melanoma
- Being tested
- Toripalimab, chemotherapy in combination with Endostar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called JS001
Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years.
chemotherapy in combination with EndostarDrug
chemotherapy+ Endostar
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy+Endostar+Toripalimab(JS001) | Experimental | Not described Receives: Drug: Toripalimab; Drug: chemotherapy in combination with Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival, PFS
PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause.
Measured: Approximately 1 years
Secondary outcomes (3)
Objective Response Rate, ORR
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Measured: Approximately 2 years
Overall Survival, OS
OS is defined as the time from the date of first treatment to death from any cause.
Measured: Approximately 2 years
Incidence of AEs/SAEs
Percentage of Participants With Adverse Events/Severe Adverse Events
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start20 Jun 2020
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Jun 2023 (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 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Fujian Cancer Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472806
- Sponsor's protocol ID
- ZLuo
- Acronym
- MTAM
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab(JS001) After Chemotherapy in Combination With Endostar in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT04472806
- Acronym / sponsor ID
- MTAM / ZLuo
- Conditions
- Mucosal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Fujian Cancer Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 15 Jul 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.
This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy+Endostar+Toripalimab(JS001) | Experimental | Drug: Toripalimab, Drug: chemotherapy in combination with Endostar |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years, male or female；
- Histopathologically confirmed and diagnosed as mucosal melanoma;
- ECOG score 0 or 1;
- Life expectancy of at least 12 weeks；
- SD/PR/CR after chemotherapy in combination with Endostar;
Key exclusion criteria (14 listed)
- Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2;
- Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;
- Skin melanoma, eye melanoma, melanoma with unknown primary foci;
- Symptomatic brain or meningeal metastases, unless the patient has been treated for > 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study;
- Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures;
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 |
|---|---|---|
| ToripalimabAlso: JS001Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically. Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years. | Drug | chemotherapy+Endostar+Toripalimab(JS001) |
| chemotherapy in combination with Endostarchemotherapy+ Endostar | Drug | chemotherapy+Endostar+Toripalimab(JS001) |
Primary outcome
Progression-Free Survival, PFS
Time frame: Approximately 1 years
PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause.
3 secondary outcomes
Objective Response Rate, ORR
Time frame: Approximately 2 years
Overall Survival, OS
Time frame: Approximately 2 years
Incidence of AEs/SAEs
Time frame: Approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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 and chemotherapy in combination with Endostar in people with Mucosal Melanoma, run by Fudan University 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 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 15 Jul 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival, PFS (time frame: Approximately 1 years). 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 15 Jul 2020.