Last updated: November 14, 2022
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting
Phase
2
Condition
Melanoma
Treatment
N/AClinical Study ID
NCT05051865
MM-IIT-SHR1210-FMTN
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8. At least one measurable lesion conforming to RECIST 1.1 criteria.
- The toxicity of prior treatment has recovered to ≤1 grade according to CTCAE 5.0 (excepted alopecia).
- ECOG score 0-1.
- The expected survival time is ≥ 12 weeks.
- Had normal swallowing function, without dysfunction of gastrointestinal absorption.
- Adequate organ and bone marrow function.
- Female patients of childbearing age must undergo a serum pregnancy test within 7 daysbefore the commencement of the study and the results are negative, and are willing touse a medically approved high potency contraceptive method during the study period andwithin 12 months after the last administration of the study drug; For male patientswhose partner is a female of childbearing age, they should be surgically sterilized oragree to use an effective method of contraception during the study period and for 12months after administration of the last study.
- Willing to consent and signed the informed consent, and able comply with the plannedvisit, research treatment, laboratory examination and other test procedures.
Exclusion
Exclusion Criteria:
- Other malignant tumors occurred in the past 5 years, except for cured skin basal cellcarcinoma, squamous cell carcinoma of skin, early stage prostate cancer and cervicalcarcinoma in situ.
- Has uveal melanoma.
- The patient has previously received anti-angiogenic drugs.
- The first study drug treatment was less than 4 weeks from the last chemotherapy or 5half-lives from the last targeted therapy; less than 4 weeks from major surgery; lessthan7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; lessthan 4 weeks from live attenuated vaccine.
- Systemic antibiotic use for 7 days within 4 weeks prior to initial administration, orunexplained fever during screening/prior to initial administration.
- Received hematopoietic stimulating factors (eg: G-CSF, EPO) within 1 week prior toinitial administration.
- Patients with central nervous system disease or brain metastases; patients who havereceived treatment, such as imaging confirmed stable has been maintained for at least 4 weeks, and have stopped systemic hormone therapy for more than 2 weeks, no clinicalsymptoms can be included.
- With active autoimmune disease or a history of autoimmune disease.
- With history of allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation.
- With immunodeficiency, eg HIV, HBV, HCV.
- Known to be allergic to the active ingredients or excipients in this study.
- Have a clear history of serious and uncontrolled other disease or mental disorders.
- Has a bleeding tendency or abnormal clotting function (INR>2.0, PT>16s).
- Other situations that the researcher considers inappropriate to participate in theresearch.
Study Design
Total Participants: 60
Study Start date:
October 09, 2021
Estimated Completion Date:
August 30, 2024
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting

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