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

NCT ID: NCT06327698

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2027-05-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination+ Anlotinib

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)

Group Type: EXPERIMENTAL

Cadonilimab

Intervention Type: DRUG

Injectable solution

anlotinib

Intervention Type: DRUG

capsule

Interventions

Cadonilimab

Injectable solution

Intervention Type: DRUG

anlotinib

capsule

Intervention Type: DRUG

Other Intervention Names

AK104

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xingxiang Pu, doctor

Role: CONTACT

puxingxiang@hnca.org.cn

+8615874180022

Other Identifiers

AK104-IIT-C-S-0010

Identifier Type: -

Identifier Source: org_study_id