Back to resultsEfficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer (GCR-05)
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Caldonirimab and Nimotuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, Caldonirimab, Nimotuzumab
Eligibility Criteria
Inclusion Criteria: Age≥18 & ≤80. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2. Subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervix Patients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic setting Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. Has adequate organ function. Life expectancy ≥3 months. Exclusion Criteria: Concurrent enrollment in another clinical study; Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent; Had received caldonirimab or nimotuzumab before; Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome. Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results). Patients with clinically significant cardio-cerebrovascular disease Known allergy or reaction to any component of the two drugs.
Sites / Locations
- The First Affiliated Hospital of Xi'an Jiao Tong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caldonirimab and nimotuzumab
Arm Description
Caldonirimab combined with nimotuzumab therapy
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1
Secondary Outcome Measures
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST 1.1
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with caldonirimab and nimotuzumab until the first documentation of disease progression or death due to any cause, whichever occurs first
Adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Full Information
NCT ID
NCT05606263
First Posted
October 31, 2022
Last Updated
May 25, 2023
Sponsor
Health Science Center of Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05606263
Brief Title
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer
Acronym
GCR-05
Official Title
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Science Center of Xi'an Jiaotong University
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
To evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer
Detailed Description
Caldonirimab, a PD-1/CTLA-4 bispecific antibody, has shown promising efficacy and tolerable toxicity in the first-line treatment of recurrent or metastatic cervical cancer. In this study, patients with recurrent or metastatic cervical cancer, after failure of first-line platinum-containing chemotherapy or intolerance to chemotherapy, will be included in this study according to the prescribed criteria in the protocal. Nimotuzumab 400 mg/time, intravenous injection, q2w, a total of 8 times; Caldonirimab 6 mg/Kg, q2w. Assess objective response rate; disease control rate; duration of overall response and safety ( adverse event).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer, Caldonirimab, Nimotuzumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caldonirimab and nimotuzumab
Arm Type
Experimental
Arm Description
Caldonirimab combined with nimotuzumab therapy
Intervention Type
Drug
Intervention Name(s)
Caldonirimab and Nimotuzumab
Intervention Description
Subjects will receive caldonirimab (6mg/Kg, q2w) until disease progression or for a maximum of 12 months, and Nimotuzumab (400mg/time, q2w) for a total of 8 cycles
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
The DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST 1.1
Time Frame
2 years
Title
Duration of response (DoR)
Description
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Time Frame
2 years
Title
Progression-free survival (PFS)
Description
Progression-free survival is defined as the time from the start of treatment with caldonirimab and nimotuzumab until the first documentation of disease progression or death due to any cause, whichever occurs first
Time Frame
2 years
Title
Adverse events (AEs)
Description
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time Frame
90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥18 & ≤80.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
Subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervix
Patients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic setting
Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
Has adequate organ function.
Life expectancy ≥3 months.
Exclusion Criteria:
Concurrent enrollment in another clinical study;
Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent;
Had received caldonirimab or nimotuzumab before;
Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results).
Patients with clinically significant cardio-cerebrovascular disease
Known allergy or reaction to any component of the two drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zi Liu, M.D
Phone
13630223132
Email
liuzmail@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiying Zhang, M.D
Phone
18984240901
Email
qyzhang1989@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zi Liu
Organizational Affiliation
Health Science Center of Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zi liu, Ph.D
Phone
+8613630223132
Email
liuzmail@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer
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