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

NCT05235516 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: AK104- 305
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Locally Advanced Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival(PFS) by investigator(INV)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 and/or biopsy

  54 months

Secondary Outcomes (2)

• PFS rate at month 36

  36 months

• Overall Survival(OS)

  5 years

Study Arms (2)

treatment arm

EXPERIMENTAL

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

placebo arm

PLACEBO COMPARATOR

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

Interventions

AK104 DRUG

q3w iv

treatment arm

EBRT RADIATION

45-50.4Gy

placebo arm; treatment arm

BT RADIATION

≥80Gy

placebo arm; treatment arm

cisplatin DRUG

qw iv

placebo arm; treatment arm

Placebo DRUG

q3w iv

placebo arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
• FIGO 2018 IVB
• Subjects who had previously undergone total hysterectomy
• Subjects who cannot receive brachytherapy
• Subjects with other active malignancies within 2 years prior to randomization
• Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
• 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).
• 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;
• Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
• Use of live vaccines within 4 weeks prior to randomization
• Active or potentially recurrent autoimmune disease
• Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• Known history of interstitial lung disease or non-infectious pneumonitis
• Pregnant or lactating women.

Sponsors & Collaborators

• Akeso: lead

Study Sites (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Guizhou Cancer Hospital

Guiyang, Guizhou, 550000, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410013, China

Location

Hunan cancer hospital

Changsha, Hunan, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310005, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jihong Liu, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yang Xiang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 11, 2022
• Study Start: June 21, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (9)