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

Melanoma Clinical Trial

Official title:

A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106023
• Other study ID #: MM-1st-IIT-SHR1701-TMZ
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Fudan University
• Contact: yong chen, MD
• Phone: 13917530417
• Email: chenyong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• SHR-1701
SHR-1701 combined with temozolomide
• Temozolomide
SHR-1701 combined with temozolomide

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yong Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR (Objective Response Rate)	Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria, subjects received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	PFS (Progression-Free-Survival)	From date of treatment start until the date of progression or the date of death due to any cause. Evaluated according to RECIST 1.1 criteria, subjects received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	From date of treatment start until the date of progression or the date of death due to any cause, assessed up to 12 months
Secondary	DCR (Disease Control Rate)	Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria, subjects received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	OS (overall survival)	From date of treatment start to any cause death or last follow-up.	From date of treatment start until the date of death from any cause or censored at the last day that the subjects are documented to be alive, whichever came first, assessed up to 36 month
Secondary	6mPFS	6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria, subjects received their first tumor imaging evaluation at 6 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	Up to 6 months
Secondary	Adverse events (per CTCAE v5.0 criteria)	To evaluate the adverse events of subjects with advanced melanoma after treated with SHR-1701 plus temozolomide	Up to 12months