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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Cadonilimab; Drug: anlotinib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xingxiang Pu, doctor; Phone Number: +8615874180022; Email: puxingxiang@hnca.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Cadonilimab; Injectable solution; Other Names: AK104; Drug: anlotinib; capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: anlotinib; cadonilimab; locally advanced or metastatic melanoma; First-Line Therapy Failure
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: AK104-IIT-C-S-0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No