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Trial Title:
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer
NCT ID:
NCT05606263
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Nimotuzumab
Conditions: Keywords:
cervical cancer
Caldonirimab
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Caldonirimab and Nimotuzumab
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
Arm group label:
Caldonirimab and nimotuzumab
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age≥18 & ≤80.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
3. Subjects must have histologically or cytologically confirmed recurrent or metastatic
carcinoma of the cervix
4. Patients have received at least one systemic therapy or who cannot tolerate
chemotherapy in the recurrent or metastatic setting
5. Has at least one measurable lesion based on Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 assessed by investigator.
6. Has adequate organ function.
7. Life expectancy ≥3 months.
Exclusion Criteria:
1. Concurrent enrollment in another clinical study;
2. Clinically significant hydronephrosis, as determined by the investigator, not
alleviated by nephrostomy or ureteral stent;
3. Had received caldonirimab or nimotuzumab before;
4. Known history of testing positive for human immunodeficiency virus (HIV) or known
active acquired immunodeficiency syndrome.
5. 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).
6. Patients with clinically significant cardio-cerebrovascular disease
7. Known allergy or reaction to any component of the two drugs.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiao Tong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
zi liu, Ph.D
Phone:
+8613630223132
Email:
liuzmail@163.com
Start date:
November 1, 2022
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Health Science Center of Xi'an Jiaotong University
Agency class:
Other
Source:
Health Science Center of Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05606263
