Clinical trial · Interventional
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
NCT06327698CI-TRIAL-00075360not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anlotinib | Drug | — | UNRESOLVED |
| Cadonilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination+ Anlotinib
- description
- Cadonilimab (AK104) (10 mg/kg, Q3W, administered on the frst day of each cycle, Q3W, until there is no clinical beneft) + anlotinib (8 mg, QD, 2 weeks off for 1 week)
- interventionNames
- Drug: Cadonilimab
- Drug: anlotinib
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- from the frst drug administration up to two years
- description
- ORR is the proportion of patients with best response of complete response (CR) and PR
Secondary outcomes (3)
- measure
- Progression-free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.