Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab will be administered as an intravenous infusion every 3 weeks, at a fixed dose of 200 mg, for 30 minutes (it is permissible, but not desirable, to carry out an infusion in the range from 25 to 40 minutes).

Premedication before administration of pembrolizumab is not mandatory.

100 mg/4 mL (25 mg/mL) concentrate for solution for infusions in a single-dose vial

The required volume (8 ml) of the Drug concentrate solution should be withdrawn from the vials and transferred into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. (The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.)

RPH-075

Keytruda®

Mikhail Samsonov

The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen.

The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy.

This study will include the following periods:

1. Screening period (before the first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial, its objectives, as well as the risks associated with participating in it, as set out in the patient information sheet.

   After the patient signs the Informed consent Form (IF), he will be examined as part of the screening period, at the end of which the researcher will decide whether or not the patient can be randomized into the study.
2. Main period (days: 1 - 168) Patients who meet the selection criteria will be randomized in a 1:1 ratio to one of the two study groups: RPH-075 and Keytruda®.

   Patients will receive pembrolizumab (RPH-075 or Keytruda®) in a monotherapy regimen, at a dose of 200 mg, intravenously, with a frequency of once every 3 weeks (3 weeks - 1 cycle).

   Therapy within the Main Study period will continue until (whichever comes first):
   * 24 weeks (8 cycles, 168 days);
   * disease progression (according to the Immune-Related Response Evaluation Criteria In Solid Tumors (iRECIST)/clinical progression);
   * the development of phenomena of intolerable toxicity.

   The assessment of tumor response to the therapy at this step will be carried out every 12 weeks.
3. Continued therapy period (days: 169 - 365) During the period of continued therapy, all patients will receive therapy with RPH-075, including those patients who received therapy with Keytruda® during the Main Study Period. Pembrolizumab will be administered intravenously, at a dose of 200 mg, with a frequency of once every 3 weeks. In case of significant AEs, pembrolizumab therapy may be postponed for up to 12 weeks.

   Therapy within the period of continued therapy will be carried out until (whichever comes first):
   * a period of up to 1 year;
   * before the disease progression (according to the criteria of iRECIST /clinical progression);
   * the development of phenomena of intolerable toxicity.

   The assessment of tumor response to the therapy at this step will be carried out every 12 weeks.
4. The period of further treatment (days: 366-730\]) Participants in this period will be patients who, after 1 year of therapy, will have a stabilization of the disease or a tumor response to therapy. The decision to switch to this period wil be made by the researcher. If, according to the decision of the researcher, the patient will not be recommended to switch to this period, then the patient goes into the Follow-up Period.

   During the the period of further treatment patients will receive therapy with RPH-075 according to the same scheme as in the period of Continued therapy.

   Therapy within the Period will be carried out until (whichever comes first):
   * a total period of up to 2 years; all examinations will be carried out within the framework of routine clinical practice;
   * before the disease progression;
   * the development of phenomena of intolerable toxicity. All examinations necessary for the patient, including radiation diagnostics, and concomitant therapy during the Period will be carried out within the framework of routine clinical practice and through the healthcare system, with the exception of visits where therapy will be administered (every 3 weeks). Also, during these visits, data on the AEs and occurrence of events (progression) will be collected.
5. Follow-up period (FU)

For patients who will have completed their planned participation, namely:

* The period of further treatment,
* The period of continued therapy (those patients who will not be transferred during the pre-treatment Period),

one follow-up visit (FU-visit) will be scheduled 28 ± 3 days after the last administration.

For patients who will complete therapy ahead of schedule (within the Main period or the Period of continued therapy), due to the progression of the disease or the development of intolerant toxicity phenomena, FU visits will be conducted with a multiplicity of 1 every 12 weeks until the Day 365 of the study.

All examinations and concomitant therapy during the Follow-up Period will be provided through the health care system (as a part of routine clinical practice), with the exception of a radiation diagnostic visit conducting to assess the response (every 12 weeks).

The total expected duration of the study is approximately 3 years. The expected duration of participation of each subject is approximately 26 months (about 2 years).

Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma

International, Multicenter, Double-blind, Randomized, Comparative Study of Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma

The objective response rate parameter (ORR) is the percentage of patients in a particular group who experienced a complete or partial tumor response to therapy during treatment, according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.

The complete response (CR) is the disappearance of all control lesions, confirmed by Computed tomography (CT) data for at least 4 weeks; the short diameter of any lymph node previously considered pathological (control or non-control) should be \< 10 mm.

The partial response (PR) is a decrease in the sum of the diameters of the control foci by 30% or more for at least 4 weeks, compared with the initial sum of the diameters of the foci (at screening).

DCR is the percentage of patients in a particular group who, during therapy, experienced a complete or partial tumor response to therapy, or disease stabilization, in accordance with RECIST 1.1 criteria.

Stabilization means no decrease in the sum of the diameters of control lesions sufficient to qualify as a PR, or an increase in the sum of diameters of control lesions that can be regarded as disease progression (DP), compared with the smallest sum of diameters recorded during observation.

DP is an increase in the sum of the diameters of control lesions by 20% or more relative to the smallest sum of diameters of control lesions recorded during observation (in this case, its absolute increase should be at least 5 mm), or the appearance of one or more new lesions.

TTR is the time from the start of study therapy to the first documented objective tumor response to therapy, according to RECIST 1.1 criteria.

The complete response (CR) is the disappearance of all control lesions, confirmed by Computed tomography (CT) data for at least 4 weeks; the short diameter of any lymph node previously considered pathological (control or non-control) should be \< 10 mm.

The partial response (PR) is a decrease in the sum of the diameters of the control foci by 30% or more for at least 4 weeks, compared with the initial sum of the diameters of the foci (at screening).

DOR is the time from the first documented objective tumor response to therapy (according to RECIST 1.1 criteria) to disease progression according to RECIST 1.1 criteria or death from any cause.

Disease progression is an increase in the sum of the diameters of control lesions by 20% or more relative to the smallest sum of diameters of control lesions recorded during observation (in this case, its absolute increase should be at least 5 mm), or the appearance of one or more new lesions.

DP is an increase in the sum of the diameters of control lesions by 20% or more relative to the smallest sum of diameters of control lesions recorded during observation (in this case, its absolute increase should be at least 5 mm), or the appearance of one or more new lesions.

Progression-free survival will be expressed as a level (%) of 6-month PFS. PFS is the time from randomization to disease progression according to RECIST 1.1 criteria or death from any cause. The PFS parameter assessment in this study is based on CT or Magnetic resonance imaging (MRI) data.

Data Management 365

Exacte Labs LLC

Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor

R-Pharm

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Head and Neck Neoplasms

The goal of this double-blind, randomized study is to establish the equivalence of pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen.

The main main tasks are:

* To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms;
* To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen.

This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy.

This study will include the following periods:

1. Screening period (before first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial, its objectives, as well as the risks associated with participating in it, as set out in the patient information sheet.

   After the patient signs the Informed consent Form (IF), he will be examined as part of the screening period, at the end of which the researcher will decide whether or not the patient can be randomized into the study.
2. Main period (days: 1 - 168) Patients who meet the selection criteria will be randomized in a 1:1 ratio to one of the two study groups: RPH-075 and Keytruda®.

   Patients will receive pembrolizumab (RPH-075 or Keytruda®) in a monotherapy regimen, at a dose of 200 mg, intravenously, with a frequency of once every 3 weeks (3 weeks - 1 cycle). In case of significant adverse events (AEs), pembrolizumab therapy may be postponed for up to 12 weeks.

   Therapy within the Main Study period will continue until (whichever comes first):
   * 24 weeks (8 cycles);
   * disease progression (according to the Immune-Related Response Evaluation Criteria In Solid Tumors (iRECIST)/clinical progression);
   * the development of phenomena of intolerable toxicity.

   The assessment of tumor response to the therapy at this step will be carried out every 12 weeks.
3. Continued therapy period (days: 169 - 365) During the period of continued therapy, all patients will receive therapy with RPH-075, including those patients who received therapy with Keytruda® during the Main Study Period. Pembrolizumab will be administered intravenously, at a dose of 200 mg, with a frequency of once every 3 weeks. In case of significant AEs, pembrolizumab therapy may be postponed for up to 12 weeks.

   Therapy within the period of continued therapy will be carried out until (whichever comes first):
   * a period of up to 1 year;
   * before the disease progression (according to the criteria of iRECIST /clinical progression);
   * the development of phenomena of intolerable toxicity.

   The assessment of tumor response to the therapy at this step will be carried out every 12 weeks.
4. The period of further treatment (days: 366-730\]) Participants in this period will be patients who, after 1 year of therapy, will have a stabilization of the disease or a tumor response to therapy. The decision to switch to this period wil be made by the researcher. If, according to the decision of the researcher, the patient will not be recommended to switch to this period, then the patient goes into the Follow-up Period.

   During the the period of further treatment patients will receive therapy with RPH-075 according to the same scheme as in the period of Continued therapy.

   Therapy within the Period will be carried out until (whichever comes first):
   * a total period of up to 2 years; all examinations will be carried out within the framework of routine clinical practice;
   * before the disease progression;
   * the development of phenomena of intolerable toxicity.

   All examinations necessary for the patient, including radiation diagnostics, and concomitant therapy during the Period will be carried out within the framework of routine clinical practice and through the healthcare system, with the exception of visits where therapy will be administered (every 3 weeks). Also, during these visits, data on the AEs and occurrence of events (progression) will be collected.
5. Follow-up period (FU)

For patients who will have completed their planned participation, namely:

* The period of further treatment,
* The period of continued therapy (those patients who will not be transferred during the pre-treatment Period),

one follow-up visit (FU-visit) will be scheduled 28 ± 3 days after the last administration.

For patients who will complete therapy ahead of schedule (within the Main period or the Period of continued therapy), due to the progression of the disease or the development of intolerant toxicity phenomena, FU visits will be conducted with a multiplicity of 1 every 12 weeks until the Day 365 of the study.

All examinations and concomitant therapy during the Follow-up Period will be provided through the health care system (as a part of routine clinical practice), with the exception of a radiation diagnostic visit conducting to assess the response (every 12 weeks).

The total expected duration of the study is approximately 3 years. The expected duration of participation of each subject is approximately 26 months (about 2 years).

Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms

International, Multicenter, Double-blind, Randomized, Comparative Study of the Pharmacokinetics, Safety and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms

The area under the pharmacokinetic curve "concentration-time" of pembrolizumab after the first (single) administration, truncated to the second administration, i.e. the point 504 hours in both treatment groups.

Incidence of ARs in both treatment groups by system Organ Class or Preferred Term

Pembrolizumab Cmax after the first administration in both treatment groups.

Pembrolizumab C(max ss) after 6th administration in both treatment groups.

Pembrolizumab C(min ss) after 6th administration in both treatment groups.

Area under the pharmacokinetic curve "concentration-time" of pembrolizumab at steady state (AUCtau ss) after 6th administration in both treatment groups.

Incidence of treatment-emergent AEs in both treatment groups by system Organ Class or Preferred Term

Incidence of imARs in both treatment groups by system Organ Class or Preferred Term

Incidence of Treatment-Emergent AEs with grade 3 or more in both treatment groups by system Organ Class or Preferred Term

Incidence of Treatment-Emergent ARs with grade 3 or more in both treatment groups by system Organ Class or Preferred Term

Incidence of imARs with grade 3 or more in both treatment groups by system Organ Class or Preferred Term

Incidence of SAEs in both treatment groups by system Organ Class or Preferred Term

Incidence of SARs in both treatment groups by system Organ Class or Preferred Term

Federal State Budgetary Institution "NMIC of Hematology" of the Ministry of Health of the Russian Federation

Nivolumab

Participants will receive 450 mg Encorafenib daily, along with 45 mg Binimetinib twice daily and 240 mg Nivolumab IV every 2 weeks.

Participants will receive 240 mg Nivolumab IV every 2 weeks

Encorafenib

Binimetinib

Malik Hall

Zeynep Eroglu, M.D.

This pilot early phase I trial studies how well encorafenib, binimetinib, and nivolumab work in treating patients with BRAF mutant stage IIIC-IV melanoma. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with nivolumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may kill more tumor cells.

Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

Pilot Study of Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

Number of participants who reach 8 weeks with the prescribed on/off schedule without progression of disease. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Time to treatment failure, defined as the time from the day of first dose of study drugs to the first day of treatment with another regimen or with the same regimen in a non-adaptive fashion.

Number of participants with tumor response. Response according to RECIST 1.1.

H. Lee Moffitt Cancer Center and Research Institute

Cases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma.

Controls will be patients 18 years or older with a histologically confirmed first primary melanoma diagnosed no earlier than 12 months prior to the study start date.

Healthy controls will be subjects 18 years or older recruited from the general population through random digit dialing. These subjects will have no history of melanoma. They will also be frequency matched to cases on the basis of sex and 10-year age group.

Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.

self-administered questionnaire and blood draw

Numbers will be randomly selected from a pool of prefixes. Numbers will be screened by computer for being working, non-business, non-fax, and non-modem numbers. After establishing eligibility for the study, we will send the potential control a letter further explaining the purpose of the study and its requirements. An interviewer will then call to arrange an appointment. During the interview, the subject will sign informed consent, be given the public health questionnaire, have 30 ml of blood drawn, and undergo the skin examination of arms and back.

health questionnaire, blood draw and skin exam

Irlene Orlow, PH.D., M.S.

The goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others. People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Genes are made up of DNA. DNA damage is one of the first steps in developing cancer. Each person has many ways to repair normal damage to their genes. Some people may have a lower level of this repair and that may make them more likely to get cancer. Some genes are important for DNA repair. The genes we want to test are thought to affect the rate at which DNA can be repaired. We also want to find out if sun habits are related to these levels of DNA repair or genetic mutations.

Differential Risks for Melanoma: p16 and DNA Repair

University of New Mexico

Yale University

Memorial Sloan Kettering Cancer Center

IRENE ORLOW, PH.D., M.S.

Patients who will receive definitive surgery for a primary malignancy of the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Patients who will receive palliative radiation (+/- concurrent systemic therapy) for any tumor involving the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Patients will be given oxygen via a facemask during the measurement session

Oxygen

Todd Tenenholz, MD

Malcolm Mattes, MD

Andrey Bobko, PhD

Timothy Eubank, PhD

Geraldine Jacobson, MD

Valery Khramtsov, PhD

Mark Tseytlin, PhD

This protocol will take measurements of a variety of tumors involving the skin in order to assess changes in tumor oxygen from hyperoxygenation therapy and standard cancer-directed treatments, to demonstrate the clinical feasibility of using in vivo Electron Paramagnetic Resonance (EPR) Oximetry to obtain clinically useful measurements of tumor oxygen levels from cancer patients.

All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s). All subjects will be assigned to one of the four cohorts for which they qualify; there is no randomization and no stratification within the cohorts.

Cohort 1 - Patients who will receive definitive surgery for a primary malignancy of the skin

Cohort 2 - Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin

Cohort 3 - Patients who will receive palliative radiation (+/- concurrent systemic therapy) for any tumor involving the skin

Cohort 4 - Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin

All patients enrolled in this study will undergo two initial measurements of their tumor oxygen level. On the first day, a small metal disc (less than 1 cm in diameter) called a SPOTChip will be placed on the surface of the tumor, and held in place using an adhesive. The patient will then be positioned (lying down or sitting) between a set of two magnets that are used to measure the oxygen level in the tumor. A small plastic oxygen detector will be placed on the skin over the tumor. These devices will be used to take a measurement of the tumor's oxygen level at baseline, then while breathing oxygen through a clear plastic facemask, and then a final time after the oxygen facemask has been removed.

After the measurements are taken, a small amount (20-50 microliters) of India ink will be injected into the tumor using a small (28-gauge) needle. The India ink will make a permanent, dark blue/black colored mark on the tumor. The ink leaves a permanent tattoo in the spot where it is injected, unless it is physically removed surgically.

The patient will return for another measurement, at least 2 days later. This measurement will use the India ink that was previously injected (described above) and there will no longer be a need to use the SPOTChip. For the India ink tumor oxygen measurement a small piece of wire (called a loop resonator) will be placed over the tumor and held in place using medical honey and saran wrap or tape. The Investigator will first take a measurement of the tumor's oxygen level at baseline, then while breathing oxygen through a clear plastic facemask, and then the mask will be taken the tumor's oxygen level will be measured as it returns to baseline.

Patients who have surgical excision of the tumor (cohort 1) will not have any further measurements after this point.

Patients who are being treated with radiation therapy (cohorts 2 \& 3), will come back for weekly measurements of the tumor during treatment, followed by one additional measurement one month after they have completed the course of radiation therapy.

Patients being treated with chemotherapy, immunotherapy, or other systemic therapies without radiation (cohort 4), will come back for measurements every 3-4 weeks around the time of their regular infusion, followed by one additional measurement one month after they complete the course of systemic therapy.

Four cohorts based on standard treatment will be given the same intervention

Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry

Tumor oxygen kinetics will be measured by EPR oximetry under ambient conditions, during hyperoxygenation therapy (100% O2 administered via a non-rebreather face mask), and immediately after hyperoxygenation therapy.

Patients will undergo weekly tumor oxygen measurements by EPR during a radiation therapy course and every 3-4 week measurements during cycles of systemic therapy. Changes in tumor oxygen will be correlated with standard measures of response to therapy using RECIST criteria.

West Virginia Clinical and Translational Science Institute

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

West Virginia University

Radiation Oncologist, Assistant Professor

Symptoms and General Pathology

Vitiligo

Hypopigmentation

Pigmentation Disorders

Hypomelanotic Disorder

Immunomodulating Agents

Adult patients diagnosed with Vitiligo according to usual criteria

metastatic melanoma patients under anti-PD-1 who did not develop Cutaneous Immune-Related Adverse Events (cutaneous irAEs).

patients with metastatic melanoma, under anti-PD-1 who developed vitiligo lesions

Metastatic melanoma who developed vitiligo lesions under anti-PD-1 who discontinued the treatment

It will be examined in patients skin swabs sampled at lesional and non-lesional sites

skin swabs at lesional and non-lesional sites

It will be examined in patients skin swabs sampled on skin

skin swabs on skin

Julien SENESCHAL, MD, PhD

Maya SALEH, PhD

The skin microbiome has been implicated in several cutaneous autoimmune pathologies such as psoriasis and atopic dermatitis. However, its role in vitiligo and vitiligo lesions occuring in patients receiving anti-PD-1 for metastatic melanoma

Melanoma is the most dangerous skin cancer accounting for the highest skin cancer deaths. The prognosis for metastatic melanoma has improved considerably in recent years thanks to advances in the field of immunotherapy. The development of molecules blocking certain immunological "checkpoints" (checkpoints exerted by the CTLA-4 (Cytotoxic T lymphocytes Associated protein 4) and PD-1 (Programmed cell Death protein 1) has made it possible to obtain a significant improvement of the overall survival (OS) of patients treated for metastatic melanoma. Ipilimumab, an antibody blocking CTLA-4, is the first immunotherapy marketed, demonstrating for the first time a therapeutic response, however in a small number of patients (10 to 15%) and with significant toxicity (25% of grade 3-4). Subsequently, a second generation of more effective checkpoint blockers (30 to 40% good response) and less toxic, anti-PD-1 antibodies (pembrolizumab and nivolumab), quickly obtained a marketing authorization in the first line treatment of metastatic melanoma treatment and recently in an adjuvant situation after lymph node dissection in order to limit the risk of recurrence. However, despite these advances, a certain number of patients do not respond to treatment and it remains difficult to predict this therapeutic response. Furthermore, patients treated with ICI often experience cutaneous immune-related adverse events manifesting as skin rash, dermatitis, epidermal necrolysis, and in some cases as vitiligo like depigmentation of the skin, testifying to the development of a specific immunogenicity towards the melanocytes, cells causing melanoma, and responsible for a discoloration of the skin. Several studies have reported that a modification of certain bacteria in the digestive microbiota was predictive of the antitumor response to immunotherapy, while others were predictive of the appearance of significant autoimmune ICI-related toxicities (colitis). Several phase 1 studies have evaluated the impact of taking probiotics or fecal transplants on the tumor response of patients receiving immunotherapy for cancer (NCT 03819296; NCT03817125; NCT03643289). Thus by these new concepts, it would be interesting to assess the composition of the skin microbiota in patients treated with anti-PD-1 immunotherapy for the management of metastatic melanoma and developing during their follow-up vitiligo; predictive side effect of improved survival. These data will be compared to those obtained from patients with common vitiligo. This will be examined in patients skin swabs sampled at lesional and non-lesional sites. Functionally, we will characterize the microbial pathways using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).

Prospective, Monocentric (CHU de Bordeaux, Department of dermatology ), with 4 groups :

* vitiligo patients
* Metastatic melanoma patients receiving anti-PD-1 but without cutaneous irAEs
* Metastatic melanoma patients receiving anti-PD-1 who developed vitiligo lesions
* metastatic melanoma patients who developed vitiligo under anti-PD-1, who discontinued the treatment.

Defining the Role of the Skin Microbiome in Immune-related Adverse Events

Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1

The composition of the skin microbiota will be characterized on skin swabs using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).

Centre National de la Recherche Scientifique, France

University Hospital, Bordeaux

Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations.

Participants receive an educational brochure as in Arm I.

Receive brochure with skin cancer education and preventative information

Written Educational Brochure

Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations

Online educational video

Jeremy Bordeaux

This randomized clinical trial uses an educational brochure and online tutorial program to assess sun-protective behavior and skin self-examination among African Americans. Skin cancer is very common among African Americans, with a disproportionately high mortality rate. Providing a brochure and an online educational program about sun-protective behaviors may encourage African Americans to take preventative measures against skin cancer, help improve early skin cancer detection, determine how far the disease has spread, and plan the best treatment.

PRIMARY OBJECTIVES:

I. To assess whether an educational brochure and online program will increase sun-protective behaviors among African-American patients who present at the general dermatology clinic.

SECONDARY OBJECTIVES:

I. To assess whether the educational brochure and online program will improve skills for skin self-examinations among African-American patients who present at the general dermatology clinic.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations.

ARM II: Participants receive an educational brochure as in Arm I.

After completion of study, participants are followed up at 30 days.

Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans

Change in sun-protective behaviors among African-American patients. Measured by sunscreen use. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups.

Change in sun-protective behaviors among African-American patients. Measured by apparel use when exposed to sun. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups.

Change in sun-protective behaviors among African-American patients. Measured by frequency of tanning. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups.

Analyzed by looking at increase or decrease in skin self-examinations the patients report from pre-intervention to post-intervention. Performance of skin self-examination is measured by knowledge, behavior, and anxiety. Most responses for questions about skin self-examinations are on a 5-point Likert scale, while some are yes/no or true/false. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. T-tests will be used to compare mean scores for skin self-examinations between groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma	NCT06320353	Skin Melanoma	RPH-075 Keytruda®	18 Years -	R-Pharm
Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms	NCT06307093	Skin Melanoma Squamous Non-sm... Head and Neck S...	RPH-075 Keytruda®	18 Years -	R-Pharm
Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma	NCT03543969	Melanoma (Skin) Skin Cancer Skin Melanoma Skin Carcinoma	Encorafenib Binimetinib Nivolumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Differential Risks for Melanoma: p16 and DNA Repair	NCT00615095	Melanoma Skin Melanoma	self-administer... self-administer... health question...	18 Years -	Memorial Sloan Kettering Cancer Center
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry	NCT03716193	Skin Lesion Skin Cancer Skin Melanoma Tumor Skin	Oxygen	18 Years - 90 Years	West Virginia University
Differential Risks for Melanoma: p16 and DNA Repair	NCT00615095	Melanoma Skin Melanoma	self-administer... self-administer... health question...	18 Years -	Memorial Sloan Kettering Cancer Center
Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms	NCT06307093	Skin Melanoma Squamous Non-sm... Head and Neck S...	RPH-075 Keytruda®	18 Years -	R-Pharm
Defining the Role of the Skin Microbiome in Immune-related Adverse Events	NCT04734704	Vitiligo Skin Melanoma	skin swabs at l... skin swabs on s...	18 Years -	University Hospital, Bordeaux
Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans	NCT02417948	Skin Carcinoma Skin Melanoma	Written Educati... Online educatio...	18 Years -	Case Comprehensive Cancer Center
Defining the Role of the Skin Microbiome in Immune-related Adverse Events	NCT04734704	Vitiligo Skin Melanoma	skin swabs at l... skin swabs on s...	18 Years -	University Hospital, Bordeaux

Spots Global Cancer Trial Database for skin melanoma