Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cadonilimab, anlotinib.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Cadonilimab
Injectable solution - Drug anlotinib
capsule
Primary outcome measures
- Response Rate [Time frame: from the frst drug administration up to two years]
Secondary outcome measures (3)
- Progression-free Survival (PFS) [Time frame: from the frst drug administration up to two years]
- Disease Control Rate (DCR) [Time frame: from the frst drug administration up to two years]
- Safety and tolerability [Time frame: from the frst drug administration up to two years]
Eligibility criteria
Inclusion criteria
- Age >18 years and ≤ 75 years
- Has a histologically confrmed diagnosis of malignant melanoma
- Previously received failed first-line treatment for melanoma
- Patients may have a history of liver metastases, but the metastases should be less than 3
- 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
- Those with at least 1 measurable lesion (RECIST version 1.1)
- ECOG 0-1
- Non-lactating patients
- Good organ function
Exclusion criteria
- 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
- Has an active or potentially recurrent autoimmune disease
- History of severe allergic reaction to any monoclonal antibody and/or component of the study drug
- Known presence of active tuberculosis TB
- Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy)
- Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study
- Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06327698 · AK104-IIT-C-S-0010