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

ConditionMelanoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab

    Drug

    Injectable solution

  • anlotinib

    Drug

    capsule

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Combination+ AnlotinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Response Rate

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

Time frame
from the frst drug administration up to two years

Secondary outcomes

1

Progression-free Survival (PFS)

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

Time frame
from the frst drug administration up to two years
2

Disease Control Rate (DCR)

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

Time frame
from the frst drug administration up to two years
3

Safety and tolerability

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

Time frame
from the frst drug administration up to two years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: