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

Cervical Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606263
• Other study ID #: GCR-5
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2023
• Source: Health Science Center of Xi'an Jiaotong University
• Contact: Zi Liu, M.D
• Phone: 13630223132
• Email: liuzmail[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Caldonirimab and Nimotuzumab
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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Health Science Center of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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