A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer (AK104-305)

Akeso

Status and phase: Active, not recruiting; Phase 3

Conditions: Locally Advanced Cervical Carcinoma

Treatments: Drug: cisplatin; Radiation: BT; Drug: AK104; Radiation: EBRT; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05235516

AK104- 305

Details and patient eligibility

About

This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer

Enrollment: 636 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. signs the written informed consent form
2. ECOG 0-1
3. Life expectancy ≥ 3 months.
4. The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
5. Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
6. At least one measurable tumor lesion per RECIST v1.1
7. Adequate organ function as assessed in the laboratory tests

Exclusion criteria

1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
2. FIGO 2018 IVB
3. Subjects who had previously undergone total hysterectomy
4. Subjects who cannot receive brachytherapy
5. Subjects with other active malignancies within 2 years prior to randomization
6. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
7. Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
8. Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization;
9. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
10. Use of live vaccines within 4 weeks prior to randomization
11. Active or potentially recurrent autoimmune disease
12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
14. Known history of interstitial lung disease or non-infectious pneumonitis
15. Pregnant or lactating women.
16. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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636 participants in 2 patient groups, including a placebo group

treatment arm

Experimental group

Treatment:

Radiation: EBRT

Drug: AK104

Radiation: BT

Drug: cisplatin

placebo arm

Placebo Comparator group

Treatment:

Drug: Placebo

Radiation: EBRT

Radiation: BT

Drug: cisplatin