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NCT Number: NCT06327698

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

cadonilimab

Drug

Injectable solution

Other names: AK104

Anlotinib

Drug

capsule

Primary outcomes

  1. Response Rate

    Time frame: from the frst drug administration up to two years

    ORR is the proportion of patients with best response of complete response (CR) and PR

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: from the frst drug administration up to two years

    Time from the date of frst study treatment administration to the date of first

  2. Disease Control Rate (DCR)

    Time frame: from the frst drug administration up to two years

    Proportion of patients whose best overall response is either CR, PR, or SD

  3. Safety and tolerability

    Time frame: from the frst drug administration up to two years

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE

Study contacts

Contact information is provided by the study sponsor or research team.

Xingxiang Pu, doctor

CONTACT

[email protected]

+8615874180022

Sponsors and collaborators

Lead sponsor

Hunan Cancer Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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