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

NCT06327698 | Not Yet Recruiting Phase 2

• 1 other identifier: AK104-IIT-C-S-0010
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

locally advanced or metastatic melanoma; cadonilimab; anlotinib; First-Line Therapy Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free Survival (PFS)

  from the frst drug administration up to two years

• Disease Control Rate (DCR)

  from the frst drug administration up to two years

• Safety and tolerability

  from the frst drug administration up to two years

Study Arms (1)

Combination+ Anlotinib

EXPERIMENTAL

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; Drug: anlotinib

Interventions

Cadonilimab DRUG

Injectable solution

Also known as: AK104

Combination+ Anlotinib

anlotinib DRUG

capsule

Combination+ Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years and ≤ 75 years
• Has a histologically confrmed diagnosis of malignant melanoma
• Previously received failed first-line treatment for melanoma
• Patients may have a history of liver metastases, but the metastases should be less than 3
• 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
• Those with at least 1 measurable lesion (RECIST version 1.1)
• ECOG 0-1
• Non-lactating patients
• Good organ function

You may not qualify if:

• 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
• Has an active or potentially recurrent autoimmune disease
• History of severe allergic reaction to any monoclonal antibody and/or component of the study drug
• Known presence of active tuberculosis TB
• Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy)
• Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study
• Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

MeSH Terms

Conditions

Melanoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xingxiang Pu, doctor

CONTACT

+8615874180022; puxingxiang@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: May 15, 2024
• Primary Completion: May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 25, 2024

Record last verified: 2024-03