A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer

NCT04868708 | Completed Phase 2

• 1 other identifier: AK104-210
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, open-label, phase II clinical study conducted in China. All subjects will receive AK104 in combination with standard treatment regimens or AK104 alone. The primary end point is safety. The secondary end point is efficacy.

Conditions

Recurrent or Metastatic Cervical Cancer

Keywords

immuno-oncology; an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody; Recurrent or metastatic cervical cancer; PD-1; CTLA-4

Outcome Measures

Primary Outcomes (1)

• AE

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

  From the time of informed consent signed through 90 days after the last dose of AK104

Secondary Outcomes (8)

• Objective response rate (ORR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (3)

AK104+Paclitaxel+Cisplatin/Carboplatin

EXPERIMENTAL

AK104 intravenously(IV) every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)

Biological: AK104; Drug: Paclitaxel; Drug: Cisplatin or Carboplatin

AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin

EXPERIMENTAL

AK104 every 3 weeks (Q3W) Bevacizumab 15mg/kg IV every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)

Biological: AK104; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin or Carboplatin

AK104

EXPERIMENTAL

AK104 IV every 2 weeks (Q2W)

Biological: AK104

Interventions

AK104 BIOLOGICAL

Subjects will receive AK104 intravenously.

AK104; AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin; AK104+Paclitaxel+Cisplatin/Carboplatin

Bevacizumab BIOLOGICAL

Subjects will receive Bevacizumab intravenously.

AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin

Paclitaxel DRUG

Subjects will receive Paclitaxel intravenously.

Also known as: PTX

AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin; AK104+Paclitaxel+Cisplatin/Carboplatin

Cisplatin or Carboplatin DRUG

Subjects will receive Cisplatin or Carboplatin intravenously.

Also known as: DDP,CBP

AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin; AK104+Paclitaxel+Cisplatin/Carboplatin

Eligibility Criteria

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

You may qualify if:

• Written and signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Estimated life expectancy of ≥3 months.
• Histologically or cytologically confirmed recurrent or metastatic cervical cancer that not appropriate for radical surgical resection and/or radical radiotherapy or chemotherapy.
• For cohort A and B: The pathological types were squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma. No previous systematic treatment for recurrent or metastatic cervical cancer.
• For cohort C: The pathological types were squamous cell carcinoma or adenosquamous cell carcinoma. Subjects must have received platinum-containing dual-drug chemotherapy combination with bevacizumab during or after the recurrence or metastasis phase and have demonstrated radiologically confirmed disease progression during or after treatment. Subjects will have no more than 2 lines of systemic therapy in the recurrence or metastatic stages.
• Subjects must have at least one measurable lesion in accordance with RECIST v1.1.
• All subjects must provide archived or freshly acquired tumor tissue samples, approximately 5 unstained FFPE pathological slides.
• Adequate organ function.
• Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first administration. If having sex with an unsterilized male partner, the subject must use an acceptable contraceptive method since screening and must agree to continue using this contraceptive method for 120 days after the last administration.

You may not qualify if:

• Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
• Other active malignancies within 2 years prior to the first administration. Subjects with locally curable tumors that appear to be cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast, were not excluded.
• Have received other study drugs or study devices within 4 weeks prior to the first administration.
• Is participating in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period for an interventional study.
• Subjects received systemic treatment with either proprietary Chinese drugs with anti-tumor indications or herbal medicines with anti-tumor effects, or immunomodulatory drugs (thymopeptide, interferon, interleukin) within 2 weeks prior to the first administration.
• Had received the last course of systemic antitumor therapy within 4 weeks prior to the first administration; Underwent major surgery within 3 weeks; Received non-specific immunoregulatory system treatment within 2 weeks; Any herbal or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks.
• Have previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies targeting ICOS, CD40, CD137, GITR, and Ox40 targets, etc.), immune cell therapy, etc. Any treatment targeted at the immune mechanism of tumor.
• Subjects had an active autoimmune disease that required systemic treatment within 2 years prior to the first administration, or an autoimmune disease that was determined by the investigator to be likely to recur or for which treatment was planned.
• Active or documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).Inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal disorders that can seriously affect the administration and absorption of drug.
• Subjects requiring systemic treatment with glucocorticoids (\> 10 mg/ day equivalent dose of prednisone) or other immunosuppressive agents within 14 days prior to the first administration.
• Known history of Immunodeficiency.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Underwent major surgery or severe trauma within 28 days prior to the first administration; Underwent surgery to improve or reduce the risk of tumor complications within 14 days prior to the first administration; Or have not fully recovered from previous surgery. Significant surgery is planned within 30 days after the first administration (as determined by the investigator).
• Medical history of gastrointestinal perforation, gastrointestinal fistula, and female reproductive tract fistula within 6 months prior to the first administration; If the perforation or fistula has been treated by excision or repair and the disease has been recovered or remitted as determined by the investigator, admission is allowed.
• Known history of interstitial lung disease.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Lou H, Cai H, Huang X, Li G, Wang L, Liu F, Qin W, Liu T, Liu W, Wang ZM, Li B, Xia Y, Wang J. Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study. Clin Cancer Res. 2024 Apr 15;30(8):1501-1508. doi: 10.1158/1078-0432.CCR-23-3162.

  PMID: 38372727 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Bevacizumab; Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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)

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

Study Officials

• Jing Wang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Hanmei Lou

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: May 3, 2021
• Study Start: April 1, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)