Combining SHR-1701 with Temozolomide for Advanced Melanoma Treatment

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

This study is testing a new immunotherapy drug called SHR-1701 combined with temozolomide to see if it can help people with advanced melanoma feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05106023 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a novel immunotherapy drug, SHR-1701, in combination with temozolomide for patients with advanced melanoma. It is a prospective, single-center, single-arm study that seeks to address the limited efficacy of single-agent immunotherapy in this patient population. The study will assess outcomes such as overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse effects using the CTCAE 5.0 grading system.

Who should consider this trial

Good fit: Ideal candidates include individuals with unresectable Stage III or IV melanoma who have not received prior systemic therapy.

Not a fit: Patients with resectable melanoma or those who have previously undergone systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new effective treatment option for patients with advanced melanoma.

How similar studies have performed: While the combination of immunotherapy and chemotherapy is being explored in various contexts, this specific combination of SHR-1701 and temozolomide is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: yong chen, MD — Fudan University
• Study coordinator: yong chen, MD

Conditions Melanoma