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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327698
• Other study ID #: AK104-IIT-C-S-0010
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 15, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: March 2024
• Source: Hunan Cancer Hospital
• Contact: Xingxiang Pu, doctor
• Phone: +8615874180022
• Email: puxingxiang[@]hnca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Cadonilimab
Injectable solution
• anlotinib
capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Outcome

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