Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure

Efficacy and Safety of Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure: A Single-arm, Open-label, Multicenter Phase II Clinical Study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06327698

Enrollment

Registered

2024-03-25

Start date

2024-05-15

Completion date

2027-05-31

Last updated

2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

locally advanced or metastatic melanoma, cadonilimab, anlotinib, First-Line Therapy Failure

Brief summary

This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.

Interventions

DRUGanlotinib

capsule

DRUGCadonilimab

Injectable solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age \>18 years and ≤ 75 years 2. Has a histologically confrmed diagnosis of malignant melanoma 3. Previously received failed first-line treatment for melanoma 4. Patients may have a history of liver metastases, but the metastases should be less than 3 5. Patients with treatment-asymptomatic brain metastases may be included, must be free of disease progression on computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 3 months, and free of steroid medication for at least 4 weeks 6. Those with at least 1 measurable lesion (RECIST version 1.1) 7. ECOG 0-1 8. Non-lactating patients 9. Good organ function

Exclusion criteria

1. Previous (within 5 years) or concurrent other malignant tumors, except for 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 without recurrence \> 3 years after radical resection 2. Has an active or potentially recurrent autoimmune disease 3. History of severe allergic reaction to any monoclonal antibody and/or component of the study drug 4. Known presence of active tuberculosis TB 5. Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy) 6. Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study 7. Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse

Design outcomes

Primary

Measure	Time frame	Description
Response Rate	from the frst drug administration up to two years	ORR is the proportion of patients with best response of complete response (CR) and PR

Secondary

Measure	Time frame	Description
Progression-free Survival (PFS)	from the frst drug administration up to two years	Time from the date of frst study treatment administration to the date of first
Disease Control Rate (DCR)	from the frst drug administration up to two years	Proportion of patients whose best overall response is either CR, PR, or SD
Safety and tolerability	from the frst drug administration up to two years	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE

Contacts

Primary ContactXingxiang Pu, doctor

puxingxiang@hnca.org.cn+8615874180022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026