Overview

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

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study is being conducted to explore the efficacy and safety of SHR-1701 combined with temozolomide in the treatment of advanced melanoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yong Chen
Treatments:
Temozolomide
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.