MelanomaPhase 2NCT04979585
Camrelizumab Plus Amlotinib and Chemotherapy in the First-line Treatment of Melanoma
A Phase 2 study testing Camrelizumab, Anlotinib and nab-Paclitaxel in people with Melanoma, run by Di Wu at 1 site in China.
Trial summary
To evaluate the objective response rate of camrelizumab combined with anlotinib and nab-paclitaxel in patients with untreated advanced mucosal 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?
- Camrelizumab, Anlotinib and nab-Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 14 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18-75 years old, gender ;
- It was confirmed by histopathology that patients with recurrence, unresectable or metastatic mucosal melanoma after surgery (stage III/IV).
- Have not received any systemic anti-tumor drug therapy in the past, and allow previous adjuvant therapy or neoadjuvant therapy (except PD-1/PDL1 monoclonal antibody and VEGFR TKI), but it is required to be completed at least 4 weeks before the first administration of the study drug, and All related toxic events have returned to normal or CTCAE4.03 grade I or below, except for hair loss).
- ECOG 0or1。
- The expected survival time is ≥12 weeks.
- Can swallow medicine normally.
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- According to the RECIST 1.1 standard, there is at least one measurable lesion, and the lesion has not been irradiated.
- Patients are allowed to have a history of brain/meningeal metastasis, but they must undergo local treatment (surgery/radiotherapy) before the start of the study, and be clinically stable for at least 3 months (allowing corticosteroids before the first use of the study drug, but before starting the study drug Need to stop for 2 weeks);
- Patients have good organ function: no blood transfusion or collection stimulation factors and plateplate production in the 14 days before the first drug was given, neutral granulocyte count ≥1.5×109/L, plate count≥ × 80×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5x normal upper limit (ULN), total bilium ≤1.5x normal upper limit Value (ULN) ALT, AST≤2.5x ULN (no liver transfer) or ≤5x ULN (e.g. liver transfer), albumin ≥30 g/L, blood clotting function requirements: international standardized ratio Value (INR≤ 1.5x ULN, coagulase original time (PT) ≤1.5x ULN, active partial clotting enzyme time (APTT) ≤1.5x ULN. Electrolyte requirements: corrected serum calcium, blood potassium,
- Women of childbearing age must have a negative serum pregnancy test result within 7 days before the first administration of the trial drug; reproductive men or women who are likely to become pregnant must use highly effective contraceptive methods (such as oral contraceptives, uterine contraceptives, etc.) during the entire trial. Internal contraceptive device, sexual desire control or barrier contraception combined with spermicide), and continue contraception for 12 months after the end of treatment.
- The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy and or VEGFR TKI therapy.
- Patients currently undergoing anti-tumor therapy.
- Patients who have participated in or are participating in clinical trials of other drugs/therapies within 4 weeks before the first use of the study drug.
- The study drug has undergone a major surgical operation or has not recovered from the side effects of this operation within 4 weeks before the first administration of the study drug, live vaccination, immunotherapy, and radiotherapy within 2 weeks
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid Hyperfunction; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included).
- The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment.
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- In the past 5 years, there is a history of other malignant tumors other than mucosal melanoma, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer and cervical carcinoma in situ.
- Patients who have received hematopoietic stimulating factors, such as granulocyte colony stimulating factor (G-CSF), erythropoietin, etc., within 1 week before the first administration of the study drug.
- The HIV antibody or Treponema pallidum antibody test result is positive.
- Patients with active hepatitis B or C: If HBsAg or HBcAb is positive, add HBV DNA (the test result is higher than the upper limit of the normal range). If the HCV antibody test result is positive, add HCV RNA (the test result is higher than the upper limit of the normal range).
- Those who are known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; those who are known to be allergic to anlotinib and any of its excipients; those who are known to be allergic to albumin paclitaxel and its excipients.
- A large amount of pleural fluid or ascites with clinical symptoms that require symptomatic treatment.
- Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Di Wu, MD, 13944888991 ext. 13944888991, Wudi991202@163.com
About this study
Official title: Camrelizumab Combined With Anlotinib and Nab-paclitaxel in Patients With Untreated Advanced Mucosal Melanoma:a Single-arm, Multicenter, Open-label Study
To evaluate the objective response rate of camrelizumab combined with anlotinib and nab-paclitaxel in patients with untreated advanced mucosal melanoma.
Read the detailed description
The current traditional cytotoxic single agent or combination chemotherapy cannot clearly improve the overall survival rate of patients with advanced melanoma.From the current point of view, combination therapy will be one of the inevitable trends in the future development of tumor immunotherapy. So carry out this research To evaluate the objective response rate of camrelizumab combined with anlotinib hydrochloride and albumin paclitaxel in the first-line treatment of patients with advanced mucosal melanoma.
- Conditions
- Melanoma
- Being tested
- Camrelizumab, Anlotinib, nab-Paclitaxel
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
200mg ,IV,d1,Q3W.
AnlotinibDrug
8mg,oral, d1-14,Q3W.
nab-PaclitaxelDrug
260mg/m2,IV,d1,Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients with untreated advanced mucosal melanoma Receives: Drug: Camrelizumab; Drug: Anlotinib; Drug: nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission.
Measured: 1 year
Secondary outcomes (1)
PFS
The time from the beginning of randomization to the onset of disease progression or the death of the patient.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Jul 2021
- Primary completion14 Apr 2023 (estimated)
- Study completion14 Aug 2023 (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
- Model description
- camrelizumab combined with anlotinib and nab-paclitaxel
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Di Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Di Wu, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979585
- Sponsor's protocol ID
- 2021-ME-01
- Status last verified
- Jul 2021
- First submitted
- 26 Apr 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Anlotinib and Nab-paclitaxel in Patients With Untreated Advanced Mucosal Melanoma:a Single-arm, Multicenter, Open-label Study
- ClinicalTrials.gov ID
- NCT04979585
- Acronym / sponsor ID
- 2021-ME-01
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Di WuUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 14 Apr 2023 (estimated)
- Study completion
- 14 Aug 2023 (estimated)
- First posted
- 28 Jul 2021 (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.
To evaluate the objective response rate of camrelizumab combined with anlotinib and nab-paclitaxel in patients with untreated advanced mucosal melanoma.
Detailed description
The current traditional cytotoxic single agent or combination chemotherapy cannot clearly improve the overall survival rate of patients with advanced melanoma.From the current point of view, combination therapy will be one of the inevitable trends in the future development of tumor immunotherapy. So carry out this research To evaluate the objective response rate of camrelizumab combined with anlotinib hydrochloride and albumin paclitaxel in the first-line treatment of patients with advanced mucosal melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- camrelizumab combined with anlotinib and nab-paclitaxel
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Camrelizumab, Drug: Anlotinib, Drug: nab-PaclitaxelPatients with untreated advanced mucosal melanoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years old, gender ;
- It was confirmed by histopathology that patients with recurrence, unresectable or metastatic mucosal melanoma after surgery (stage III/IV).
- Have not received any systemic anti-tumor drug therapy in the past, and allow previous adjuvant therapy or neoadjuvant therapy (except PD-1/PDL1 monoclonal antibody and VEGFR TKI), but it is required to be completed at least 4 weeks before the first administration of the study drug, and All related toxic events have returned to normal or CTCAE4.03 grade I or below, except for hair loss).
- ECOG 0or1。
- The expected survival time is ≥12 weeks.
Key exclusion criteria (13 listed)
- Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy and or VEGFR TKI therapy.
- Patients currently undergoing anti-tumor therapy.
- Patients who have participated in or are participating in clinical trials of other drugs/therapies within 4 weeks before the first use of the study drug.
- The study drug has undergone a major surgical operation or has not recovered from the side effects of this operation within 4 weeks before the first administration of the study drug, live vaccination, immunotherapy, and radiotherapy within 2 weeks
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid Hyperfunction; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included).
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 |
|---|---|---|
| Camrelizumab200mg ,IV,d1,Q3W. | Drug | Experimental |
| Anlotinib8mg,oral, d1-14,Q3W. | Drug | Experimental |
| nab-Paclitaxel260mg/m2,IV,d1,Q3W. | Drug | Experimental |
Primary outcome
ORR
Time frame: 1 year
defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission.
1 secondary outcome
PFS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Anlotinib and nab-Paclitaxel in people with Melanoma, run by Di Wu at 1 site in China.
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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Guo (0431-88782013, guodi17790060921@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). 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 3 Aug 2021.