Clinical trial · Interventional
To Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma
A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma
NCT05106023CI-TRIAL-00066973unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being conducted to explore the efficacy and safety of SHR-1701 combined with temozolomide in the treatment of advanced melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1701 | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1701 combined with temozolomide
- description
- SHR-1701 combined with temozolomide
- interventionNames
- Drug: SHR-1701
- Drug: Temozolomide
Primary outcomes (1)
- measure
- ORR (Objective Response Rate)
- timeFrame
- 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
- description
- 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.
Secondary outcomes (5)
- measure
- PFS (Progression-Free-Survival)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.