Combining Caldonirimab and Nimotuzumab for Advanced Cervical Cancer

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

This study is testing a new combination of two drugs, caldonirimab and nimotuzumab, to see if they can help people with advanced cervical cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Xi'an Jiaotong University (Academic / other)
• Drugs / interventions: caldonirimab, nimotuzumab, chemotherapy
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT05606263 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of caldonirimab, a PD-1/CTLA-4 bispecific antibody, combined with nimotuzumab as a second-line treatment for patients with recurrent or metastatic cervical cancer. Participants must have previously failed or been intolerant to first-line platinum-containing chemotherapy. The treatment regimen includes intravenous administration of nimotuzumab and caldonirimab, with assessments focused on objective response rates, disease control rates, duration of response, and safety profiles. The study aims to provide new therapeutic options for patients with limited treatment alternatives.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed recurrent or metastatic cervical cancer who have previously received systemic therapy or cannot tolerate chemotherapy.

Not a fit: Patients with concurrent significant health issues, such as active infections or those who have previously received the study drugs, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with recurrent or metastatic cervical cancer who have limited choices.

How similar studies have performed: While the combination of PD-1 and CTLA-4 inhibitors is a novel approach, similar studies have shown promise in other cancer types, suggesting potential for success in this context.

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.

Where this trial is running

Xi'an, Shaanxi

• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Zi Liu — Xi'an Jiaotong University
• Study coordinator: Zi Liu, M.D

Conditions Cervical Cancer; cervical cancer; Caldonirimab; Nimotuzumab