Back to resultsTo Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma
Primary Purpose
Melanoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1701
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
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.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1701 combined with temozolomide
Arm Description
SHR-1701 combined with temozolomide
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
OS (overall survival)
From date of treatment start to any cause death or last follow-up.
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.
Adverse events (per CTCAE v5.0 criteria)
To evaluate the adverse events of subjects with advanced melanoma after treated with SHR-1701 plus temozolomide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05106023
Brief Title
To Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Chen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1701 combined with temozolomide
Arm Type
Experimental
Arm Description
SHR-1701 combined with temozolomide
Intervention Type
Drug
Intervention Name(s)
SHR-1701
Other Intervention Name(s)
SHR1701
Intervention Description
SHR-1701 combined with temozolomide
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
SHR-1701 combined with temozolomide
Primary Outcome Measure Information:
Title
ORR (Objective Response Rate)
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.
Time Frame
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 Outcome Measure Information:
Title
PFS (Progression-Free-Survival)
Description
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.
Time Frame
From date of treatment start until the date of progression or the date of death due to any cause, assessed up to 12 months
Title
DCR (Disease Control Rate)
Description
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.
Time Frame
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
Title
OS (overall survival)
Description
From date of treatment start to any cause death or last follow-up.
Time Frame
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
Title
6mPFS
Description
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.
Time Frame
Up to 6 months
Title
Adverse events (per CTCAE v5.0 criteria)
Description
To evaluate the adverse events of subjects with advanced melanoma after treated with SHR-1701 plus temozolomide
Time Frame
Up to 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yong chen, MD
Phone
13917530417
Email
chenyong@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yong chen, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yong chen, MD
Phone
13917530417
Email
chenyong@fudan.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma
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