Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer

Study Overview
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Brief Summary
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To evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer

Detailed Description
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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).

Official Title
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Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Trial

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Caldonirimab and Nimotuzumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caldonirimab and nimotuzumab<br>Caldonirimab combined with nimotuzumab therapy | Drug: Caldonirimab and Nimotuzumab<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST 1.1 | 2 years | 
| 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 | 2 years | 
| 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 | 2 years | 
| 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 | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, Caldonirimab, Nimotuzumab