MelanomaPhase 2NCT06327698
Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure
A Phase 2 study testing Cadonilimab and anlotinib in people with Melanoma, run by Hunan Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Cadonilimab and anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- ECOG 0-1
- Non-lactating patients
- Good organ function
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Also called AK104
Injectable solution
anlotinibDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Cadonilimab; Drug: anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
ORR is the proportion of patients with best response of complete response (CR) and PR
Measured: from the frst drug administration up to two years
Secondary outcomes (3)
Progression-free Survival (PFS)
Time from the date of frst study treatment administration to the date of first
Measured: 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
Measured: 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
Measured: from the frst drug administration up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 May 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327698
- Sponsor's protocol ID
- AK104-IIT-C-S-0010
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06327698
- Acronym / sponsor ID
- AK104-IIT-C-S-0010
- Conditions
- Melanoma
- Keywords
- locally advanced or metastatic melanoma, cadonilimab, anlotinib, First-Line Therapy Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination+ Anlotinib | Experimental | Drug: Cadonilimab, Drug: anlotinibCadonilimab (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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CadonilimabAlso: AK104Injectable solution | Drug | Combination+ Anlotinib |
| anlotinibcapsule | Drug | Combination+ Anlotinib |
Primary outcome
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
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: from the frst drug administration up to two years
Disease Control Rate (DCR)
Time frame: from the frst drug administration up to two years
Safety and tolerability
Time frame: from the frst drug administration up to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab and anlotinib in people with Melanoma, run by Hunan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingxiang Pu, doctor (+8615874180022, puxingxiang@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: from the frst drug administration up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.