A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

NCT04982237 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: AK104-303
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 5

Brief Summary

This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1

  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

  Up to approximately 2 years

• overall survival (OS)

  OS is defined as the time from randomization to death due to any cause.

  Up to approximately 2 years

Secondary Outcomes (6)

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

  Up to approximately 2 years

• Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

  Up to approximately 2 years

• Time to Response（TTR Per RECIST 1.1 as Assessed by BICR

  Up to approximately 2 years

• AE

  Up to approximately 2 years

• Observed concentrations of AK104

  From first dose of AK104 through 90 days after last dose of AK104

Study Arms (2)

AK104+chemotherapy± bevacizumab

EXPERIMENTAL

AK104 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Biological: AK104; Drug: paclitaxel; Drug: carboplatin; Drug: cisplatin; Drug: bevacizumab

Placebo+chemotherapy± bevacizumab

PLACEBO COMPARATOR

Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Drug: paclitaxel; Drug: carboplatin; Drug: cisplatin; Drug: bevacizumab; Drug: Placebo

Interventions

AK104 BIOLOGICAL

IV infusion

AK104+chemotherapy± bevacizumab

paclitaxel DRUG

IV infusion

AK104+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

carboplatin DRUG

iv infusion

AK104+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

cisplatin DRUG

iv infusion

AK104+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

bevacizumab DRUG

iv infusion

AK104+chemotherapy± bevacizumab; Placebo+chemotherapy± bevacizumab

Placebo DRUG

iv infusion

Placebo+chemotherapy± bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signs the written informed consent form.
• Women aged ≥ 18 and ≤ 75 years.
• ECOG of 0 or 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.
• The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;
• No prior systemic therapy for persistent, recurrent or metastatic (\[FIGO\] Stage IVB) disease.
• At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.
• All subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.
• Subjects must have adequate organ function as assessed in the laboratory tests.
• Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.

You may not qualify if:

• Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
• Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator.
• Presence of nervous system (CNS) metastases or carcinomatous meningitis;
• Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Patients with other active malignancies within 3 years prior to randomization.
• Patients who have received other prior chemotherapeutic agents.
• Any prior treatments targeting the mechanism of tumor immunity, such as anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc).
• Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.
• Active or potentially recurrent autoimmune disease.
• 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;
• Use of live vaccines within 4 weeks prior to randomization.
• 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; unless induced by radiation therapies.
• Serious infections requiring hospitalization.

Sponsors & Collaborators

• Akeso: lead

Study Sites (5)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Anhui Provincial Hospital

Hefei, China

Location

The Second Affiliated Hospital,Anhui Medical University

Hefei, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

• Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16.

  PMID: 39426385 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Paclitaxel; Carboplatin; Cisplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaohua Wu, MD

  Fudan University

  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: July 21, 2021
• First Posted: July 29, 2021
• Study Start: August 27, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (5)