To Explore the Efficacy and Safety of Camrelizumab Combined With SHR1020 in the Treatment of Advanced Melanoma

Last updated: November 14, 2022
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Melanoma

Treatment

N/A

Clinical Study ID

NCT05051865
MM-IIT-SHR1210-FMTN
  • Ages 18-75
  • All Genders

Study Summary

This study is being conducted to explore the efficacy and safety of camrelizumab combined with SHR1020 in the treatment of advanced melanoma.

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

This trial is a prospective, single-center, single-arm clinical research. Based on current experience, single agent immunotherapy has limited efficacy in advanced melanoma. SHR1020 is a multi-target tyrosine kinase inhibitor. This study is aiming to evaluate the efficacy and safety of camrelizumab combined with SHR1020 in patients with advanced melanoma. The safety and efficacy of this study will be assessed through ORR, DCR, PFS, OS and adverse effects as graded by CTCAE 5.0.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

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