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Cadonilimab (AK104) Plus Chemotherapy in Patients With Recurrent or Advanced Endometrial Cancer

ConditionsEndometrial CancerEndometrial Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFujian Cancer Hospital

About this trial

This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with chemotherapy in patients with recurrent or advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Patients must have had measurable stage III,IVA or recurrent endometrial cancer,and not suitable for curative radiotherapy or surgery.

All patients were required to have histologic confirmation of the original primary tumor (submission of pathology report(s) is required). Patients with the following histologic types were eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, etc.

The subject has not received systematic chemotherapy in the advanced or recurrent disease, but is allowed to receive neoadjuvant therapy, adjuvant therapy (including chemotherapy, radiotherapy, or endocrine therapy) in the initial treatment stage, and the last adjuvant chemotherapy is required to be completed at least 6 months before enrollment. The final adjuvant radiotherapy, palliative radiotherapy (such as radiotherapy for bone metastases), and endocrine therapy should be completed at least 3 weeks before enrollment. For palliative radiotherapy of central nervous system (CNS) diseases, washout is allowed for one week.

Disqualifiers

Other malignant tumors in the past (within 5 years) or at the same time, excluding cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer and thyroid cancer that have no recurrence more than 3 years after the completion of radical surgery.

Had received immunotherapy in the past, it includes immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) , immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibody, etc.) , immune cell therapy, etc. Such subjects may be admitted with the consent of the sponsor.

Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Previous history of immunodeficiency; HIV antibody positive; Current long-term use of systemic corticosteroids or other immunosuppressants

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab

    Drug

    Injectable solution

  • Carboplatin

    Drug

    Injectable solution

  • Cisplatin

    Drug

    Injectable solution

  • Paclitaxel

    Drug

    Injectable solutionS

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Cadonilimab+carboplatin/cisplatin+paclitaxelExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Response Rate (ORR)

ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
from the first drug administration up to two years

Secondary outcomes

1

Disease Control Rate (DCR)

Proportion of patients whose best overall response is either CR, PR, or SD

Time frame
from the first drug administration up to two years
2

Duration of response (DOR)

Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first

Time frame
from the first drug administration up to two years
3

Progression-free Survival (PFS)

Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first

Time frame
from the first drug administration up to two years
4

Overall survival (OS)

Time from the date of first study treatment administration to the date of death due to any cause

Time frame
from the first drug administration up to two years

Other outcomes

1

Biomarkers associated with the response to cadonilimab plus chemotherapy

Exploration of biomarkers that predict the efficacy of cadonilimab combined with chemotherapy

Time frame
Samples taken prior to the first dose of drug to confirm the result of MSI-H/dMMR and PD-L1

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Fujian Provincial Hospital

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

Collaborator

The First Affiliated Hospital of Bengbu Medical University

Collaborator

Source ClinicalTrials.gov

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