Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix

NCT05063916 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0585NCI-2021-10701
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, single center, open-label, single-arm study designed to evaluate the efficacy, safety, tolerability, and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic high grade neuroendocrine cervical cancer.

Conditions

Cervix Cancer; Cervical Cancer; Carcinomas

Outcome Measures

Primary Outcomes (1)

• To establish the progression free survival rate at 6 months (PFS6) in response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix

  (up to 6 months) through study completion, an average of 1 year

Study Arms (1)

AK104

EXPERIMENTAL

cadonilimab) can help to control neuroendocrine cervical cancer that is recurrent (has come back after treatment) or metastatic (has spread).

Drug: AK104

Interventions

AK104 DRUG

Given By IV

Also known as: Cadonilimab

AK104

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written and signed informed consent.
• Age ≥ 18 years at time of study entry
• Histologically or cytologically confirmed recurrent or metastatic high grade neuroendocrine carcinoma of the cervix with disease progression confirmed by radiologic imaging during or following prior platinum-based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer
• Received no more than 2 prior systemic therapies in the recurrent or metastatic setting
• Not eligible for surgery and/or radiation as treatment options for recurrent disease
• Measurable lesions according to RECIST v1.1. (A previously irradiated lesion is not considered measurable and cannot be selected as a target lesion.)
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
• Adequate organ function as determined by:
• Hematological criteria (subjects should not have received either growth factor support or recent transfusions within 7 days prior to starting study treatment):
• Absolute neutrophil count (ANC) ≥1.5 × 109/L (1,500/mm3)
• Platelet count ≥100 × 109/L (100,000/mm3)
• Hemoglobin ≥9.0 g/dL (90 g/L)
• Renal criteria:
• \- Serum creatinine \<1.5 × upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 by Cockcroft-Gault formula
• Hepatic criteria:

You may not qualify if:

• Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study
• Histological types of cervical cancer other than high grade neuroendocrine caricnoma (e.g.
• squamous carcinoma, adenocaricnoma, adeno-squamous carcinoma, clear cell carcinoma, sarcoma, etc.)
• Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the breast
• Brain/central nervous system (CNS) metastases: Subjects with suspected brain metastases should have a computed tomography (CT)/magnetic resonance imaging (MRI) scan of the brain to confirm the absence of brain/CNS metastases prior to enrollment.
• Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent
• Active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 4 weeks prior to the first dose of investigational product.
• 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).
• Active or prior documented autoimmune disease that may relapse. NOTE: Subjects with controlled type 1 diabetes mellitus, thyroiditis in euthyroid state or hypothyroidism well managed by hormone replacement therapy (HRT), or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis) are eligible.
• History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.
• Clinically significant cardio-cerebrovascular disease:
• Myocardial infarction, unstable angina, pulmonary embolism, stroke, or any other significant cardiovascular or cerebrovascular accident within 6 months prior to the first dose of investigational product.
• New York Heart Association Grade III or greater congestive heart failure within 6 months prior to the first dose of investigational product.
• Serious cardiac arrhythmia such as ventricular arrhythmia requiring medication or second- or third-degree atrioventricular block. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Amir Jazaeri

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 1, 2021
• Study Start: February 28, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)