Loading clinical trials...

Camrelizumab Plus Amlotinib and Chemotherapy in the First-line Treatment of Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Camrelizumab Plus Amlotinib and Chemotherapy in the First-line Treatment of Melanoma

Camrelizumab Combined With Anlotinib and Nab-paclitaxel in Patients With Untreated Advanced Mucosal Melanoma:a Single-arm, Multicenter, Open-label Study

NCT04979585•Di Wu

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-75 years old, gender ;
•2. It was confirmed by histopathology that patients with recurrence, unresectable or metastatic mucosal melanoma after surgery (stage III/IV).
•3. 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).
•4. ECOG 0or1。
•5. The expected survival time is ≥12 weeks.
•6. Can swallow medicine normally.
•7. According to the RECIST 1.1 standard, there is at least one measurable lesion, and the lesion has not been irradiated.
•8. 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);
•9. 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,
•10. 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.
+1 more criteria

Exclusion Criteria

•1. Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy and or VEGFR TKI therapy.
•2. Patients currently undergoing anti-tumor therapy.
•3. 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.
•4. 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
•5. 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).
•6. 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.
•7. 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.
•8. 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.
•9. The HIV antibody or Treponema pallidum antibody test result is positive.
•10. 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).
+3 more criteria

Locations (1)

The first hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

July 15, 2021

Primary Completion Date

April 14, 2023

Completion Date

August 14, 2023

Last Updated

August 3, 2021

Enrollment

ESTIMATED participants

Conditions

Melanoma

Interventions

Camrelizumab

DRUG

Anlotinib

DRUG

nab-Paclitaxel

DRUG

Contacts

Di Guo

CONTACT

0431-88782013 guodi17790060921@126.com

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

RECRUITINGPHASE1

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Camrelizumab Plus Amlotinib and Chemotherapy in the First-line Treatment of Melanoma

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma