Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma

STATUS

Recruiting
participants needed

31
sponsor

Fudan University

Send

Updated on 19 February 2024

See if I qualify

maintenance treatment

toripalimab

mucosal melanoma

oral contraceptives

melanoma

Summary

This study is a multicenter, single-arm, open, phase 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.

Details

Condition	Mucosal Melanoma
Age	18-75 years
Treatment	Toripalimab, chemotherapy in combination with Endostar
Clinical Study Identifier	NCT04472806
Sponsor	Fudan University
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

maintenance treatment

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma