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AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05430906
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Hunan Cancer Hospital

Brief Summary:

Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile.

AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: AK104 - Chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: AK104+chemotherapy
Participants received 3-4 neo-adjuvant cycles of standard 3 weekly AK104 10mg/kg then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)]; followed by surgery
Drug: AK104 - Chemotherapy
AK104 10mg/kg then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)] of each 21-day cycle




Primary Outcome Measures :
  1. Complete(R0) resection rate [ Time Frame: Average 4 months after the start of drugs ]
    The margin of the resected specimen showed no tumour involvement


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days) ]
    The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

  2. Disease control rate (DCR) [ Time Frame: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days) ]
    The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.

  3. Pathological Complete Response (pCR) Rate [ Time Frame: One week after the surgery ]
    The pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

  4. Progression-free survival (PFS) [ Time Frame: From the date of the start of drugs to date event, assessed up to 1 years ]
    Progression-free survival is defined as the time from the start of drugs until the first documentation of disease progression or death due to any cause, whichever occurs first.

  5. Number of participants with adverse events (AEs) [ Time Frame: From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment ]
  6. Number of participants with surgical complications [ Time Frame: Intraoperatively, within 30 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

- 1. Woman ≥ 18 and ≤ 75 years old on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended.

4. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function.

Key Exclusion Criteria:

  • 1. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary.

    2. Patients with other active malignancies within 5 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

    5. Presence of other uncontrolled serious medical conditions.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430906


Contacts
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Contact: Jie Tang +8615274836636 tangjie@hnca.org.cn

Sponsors and Collaborators
Hunan Cancer Hospital
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Responsible Party: Hunan Cancer Hospital
ClinicalTrials.gov Identifier: NCT05430906    
Other Study ID Numbers: AK104-IIT-003
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type