NCT06327698Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 15 May 2024
- Primary completion date
- 31 May 2026
- Lead sponsor
- Hunan Cancer Hospital
- Diseases
- Melanoma
- NCT number
- NCT06327698
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 15 May 2024 to the primary completion date, 31 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.