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Trial Title:
Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure
NCT ID:
NCT06327698
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
locally advanced or metastatic melanoma
cadonilimab
anlotinib
First-Line Therapy Failure
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Injectable solution
Arm group label:
Combination+ Anlotinib
Other name:
AK104
Intervention type:
Drug
Intervention name:
anlotinib
Description:
capsule
Arm group label:
Combination+ Anlotinib
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 15, 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Source:
Hunan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327698
