To Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma

NCT ID: NCT05106023

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2023-12-31

Brief Summary

This study is being conducted to explore the efficacy and safety of SHR-1701 combined with temozolomide in the treatment of advanced melanoma.

Detailed 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. SHR-1701 is a novel immunotherapy drug . Preclinical data suggest that temozolomide selectively depletes regulatory T cells. This potential immunomodulatory effect of temozolomide provides rationale for combination with SHR-1701. This study is aiming to evaluate the efficacy and safety of SHR-1701 combined with temozolomide 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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1701 combined with temozolomide

SHR-1701 combined with temozolomide

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

SHR-1701 combined with temozolomide

Temozolomide

Intervention Type: DRUG

SHR-1701 combined with temozolomide

Interventions

SHR-1701

SHR-1701 combined with temozolomide

Intervention Type: DRUG

Temozolomide

SHR-1701 combined with temozolomide

Intervention Type: DRUG

Other Intervention Names

SHR1701

Eligibility Criteria

Inclusion Criteria

• Has unresectable Stage III or Stage IV or melanoma per American Joint Committee on Cancer (AJCC) staging system version 8. At least one measurable lesion conforming to RECIST 1.1 criteria.
• No previously received systematic therapy.
• The toxicity of prior treatment has recovered to ≤1 grade according to CTCAE 5.0.
• ECOG score 0-1.
• The expected survival time is ≥ 12 weeks.
• Adequate organ and bone marrow function.
• Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study.
• Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria

• History of other malignant tumors, except for cured skin basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder carcinoma, papillary thyroid carcinoma, intraductal carcinoma and cervical carcinoma in situ.
• Has ocular melanoma.
• The first study drug treatment was less than 4 weeks from the last systematic antitumor therapy or 5 half-lives from the last targeted therapy; less than 4 weeks from major surgery; less than7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; less than 4 weeks from live attenuated vaccine.
• Systemic antibiotic use for 7 days within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration.
• With active autoimmune disease or a history of autoimmune disease.
• With history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• With immunodeficiency, eg HIV, HBV, HCV.
• Have a clear history of serious and uncontrolled other disease or mental disorders.
• Has a bleeding tendency or abnormal clotting function.
• Subjects with central nervous system disease or brain metastases.
• Known to be allergic to the active ingredients or excipients in this study.
• Other situations that the researcher considers inappropriate to participate in the research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong Chen

OTHER

Sponsor Role: lead

Responsible Party

Yong Chen

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

yong chen, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

yong chen, MD

Role: CONTACT

chenyong@fudan.edu.cn

13917530417

Facility Contacts

yong chen, MD

Role: primary

chenyong@fudan.edu.cn

13917530417

Other Identifiers

MM-1st-IIT-SHR1701-TMZ

Identifier Type: -

Identifier Source: org_study_id