- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878977
Biomarkers in Immunotherapy of Melanoma
May 17, 2023 updated by: Institute of Oncology Ljubljana
Effectiveness of Immunotherapy in the First-line Treatment of Disseminated Melanoma and Recognition of Prognostic and Predictive Biomarkers From the Primary Tumor, Stool and Body Fluids: PROTOCOL TRIAL
Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs).
Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response.
This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients.
Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the study.
Stool samples are submitted before the start of treatment, at the 12 (+/-2) week and 28 (+/-4) week, and at the event ( such as, suspected disease progression/hyperprogressio, immune related adverse event (irAE), etc).
Peripheral venous blood samples are taken additionaly at the same time points for cytologic and molecular tests.
Histological material from the tumor tissue is obtained before the start of immunotherapy treatment.
Primary objectives are to determine whether human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ predict response to treatment with PD-1 and CTLA-4 inhibitors and are associated with occurrence of irAE in patients with metastatic melanoma at different time points.
Response is evaluated radiologically with imaging methods in accordance with the irRECIST criteria.
Conclussion: Despite the great success of the treatment of metastatic melanoma with immunotherapy, there remains a significant proportion of patients who do not respond to treatment or who develop severe adverse events during treatment.
Identification of novel predictive and prognostic biomarkers for immunotherapy treatment response is therefore necessary.
This study is the first to combine and investigate multiple potential predictive and prognostic biomarkers and its dynamics.
The results could serve for a better and multi-level understanding of the various factors influencing immunotherapy treatment.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tanja Mesti
- Phone Number: 0038615879287
- Email: tmesti@onko-i.si
Study Locations
-
-
-
Ljubljana, Slovenia
- Recruiting
- Institute of Oncology Ljubljana
-
Contact:
- Tanja Mesti
- Phone Number: +38615879287
- Email: tmesti@onko-i.si
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age over 18 years
- Cytologically or histologically verified malignant melanoma
- Stage IIID unresectable/IV according to AJCC classification (8th edition, 2018)
- Performance status according to WHO 0 - 2 (ECOG criteria)
- 1st line of systemic treatment with immunotherapy (nivolumab, ipi/nivo, pembrolizumab)
- Triple CT/PET CT done within 4 weeks before the first application
- Signed consent to participate in clinical research
Exclusion Criteria:
- Previously treated melanoma with systemic therapy
- Capacity status according to WHO 3 - 4 (ECOG criteria)
- Contraindications for immunotherapy treatment (known deficiency of the immune system or active immunosuppressive treatment or active autoimmune disease requiring treatment)
- Other malignant diseases (except cured basal cell carcinoma and squamous cell carcinoma)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Immune checkpoint inhibitors
|
Identification of novel predictive and prognostic biomarkers for immunotherapy treatment response in metastatic melanoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response prediction in first line immune checkpoint inhibitors treatment in metastatic melanoma assessed by human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ
Time Frame: 3 years
|
Primary objectives are to determine whether human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ predicts response to treatment with PD-1 and CTLA-4 inhibitors and are associated with occurrence of irAE in patients with metastatic melanoma.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
Other Study ID Numbers
- ERIDNPVO-0034/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Melanoma
-
Mohammed M MilhemGenentech, Inc.TerminatedMelanoma | Metastatic Melanoma | BRAF-mutated Metastatic Melanoma | V600EBRAF-mutated Metastatic MelanomaUnited States
-
Delcath Systems Inc.Active, not recruitingMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
National Cancer Institute (NCI)TerminatedMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
MorphotekTerminatedMelanoma | Metastatic Melanoma | Advanced Melanoma | Malignant Metastatic MelanomaUnited States
-
GlaxoSmithKlineWithdrawnCancer | Metastatic Uveal Melanoma | GNA11 Mutation-positive Metastatic Melanoma | GNAQ Mutation-positive Metastatic Melanoma
-
Elizabeth DavisBristol-Myers SquibbTerminatedMetastatic Melanoma | Advanced Melanoma | Metastatic Melanoma Stratified by MHC-II ExpressionUnited States
-
Provectus Biopharmaceuticals, Inc.Active, not recruitingMetastatic Colorectal Cancer | Hepatocellular Carcinoma | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Melanoma | Metastatic Uveal Melanoma | Metastatic Pancreatic Cancer | Metastatic Colon Cancer | Metastatic Ocular Melanoma | Cancer Metastatic to the LiverUnited States
-
Fred Hutchinson Cancer CenterAmazon.com Services LLCRecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Cutaneous Melanoma | Unresectable Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Recurrent Cutaneous Melanoma | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Recurrent Mucosal Melanoma | Metastatic Mucosal Melanoma | Non-Cutaneous Melanoma | Metastatic Non-Cutaneous Melanoma | Recurrent Non-Cutaneous...United States, Canada, Ireland
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMetastatic Melanoma | Metastatic Uveal Melanoma | Unresectable Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | Pathologic Stage III Cutaneous... and other conditionsUnited States
Clinical Trials on Immune checkpoint inhibitor
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenRecruitingNSCLC | Lung Diseases, Interstitial | ImmunotherapyBelgium
-
VastBiomeRecruitingRenal Cell Carcinoma | Non-Small-Cell Lung Carcinoma | Malignant Melanoma | Triple-Negative Breast CancerUnited States
-
Groupe Hospitalier Pitie-SalpetriereInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedAutoimmune Diseases | Endocrine System Diseases | Cancer | Arthritis | Myositis | Neuropathy | Cardiac Disease | OphthalmopathyFrance
-
Peking University Cancer Hospital & InstituteNot yet recruitingNon Small Cell Lung CancerChina
-
Ospedale Maggiore Di TriesteUnknownHodgkin Lymphoma | Radiotherapy | Immune Checkpoint InhibitorItaly
-
Institut BergoniéInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedCancer Treated With Immune-checkpoint InhibitorsFrance
-
Groupe Hospitalier Pitie-SalpetriereInstitut CurieCompletedCancer | Immune Checkpoint Inhibitor-Related Myocarditis | Immune-related Adverse EventFrance
-
Hunan Province Tumor HospitalCompletedNon Small Cell Lung CancerChina
-
John L. Villano, MD, PhDRecruitingSquamous Cell Carcinoma of the Head and Neck | Non-small Cell Lung CancerUnited States
-
Sun Yat-sen UniversityNot yet recruitingImmune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular CarcinomaChina