Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

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 Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Vaccines

Carbamide Peroxide

This is a single-arm phase I trial in patients with AJCC stage IIB, IIC, III, and IV (MIa) melanoma in which autologous human Langerhans-type dendritic cells (CD34+hematopoietic progenitor cell (HPC)-derived Langerhans cells, or LCs) will be electroporated with mRNA encoding full-length murine tyrosinase-related peptide 2 (TRP2). LCs will also be loaded with control antigens (HLA-A\*0201-restricted flu matrix peptide).

Patients will receive a total of 5 vaccinations, comprising a primary immunization followed by four boosters at 3 week intervals with a window of ± 4 days. Vaccines will be dosed at 10x106 LCs per vaccine x 5.

Langerhans-type dendritic cells (a.k.a. Langerhans cells or LCs)

James Young, MD

This study is being done to see if the investigators can help the immune system to work against melanoma.

A dendritic cell is another type of white blood cell. It has most, if not all, of the proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the antigens with dendritic cells to make a vaccine. The investigators think that the body's T cells might then react against the tumor and help destroy it.

This study will see if altered dendritic cells will make T cells work against tumor cells. The dendritic cells will be made in a lab and will carry the antigens. These cells then will be injected under the skin.

In this study, the investigators are trying to help the body make a stronger immune response against the cancer. The patient will get the same kind of dendritic cell vaccine used in the earlier study, but with one major difference. The dendritic cells will contain messenger-RNA (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a laboratory method called electroporation. The mRNA is never given to the patient directly. This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses. The dendritic cell can then put this tumor antigen on its surface so that the body could make a stronger immune response against the tumor.

Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma

Toxicity will be graded according to standard NCI/CTEP toxicity criteria. This protocol will use the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Toxicity will be graded according to standard NCI/CTEP toxicity criteria. This protocol will use the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Due to the nature of this treatment and the expected mild erythema and occasional pruritus, only grade 3-4 toxicities will be evaluated

For this study, the vaccine is considered promising if more than four out of the nine patients have an immunologic response (e.g., tetramer staining and intracellular cytokine secretion assays). Samples taken after vaccination will be considered positive for response if they are higher than the pre-vaccination values by at least two standard deviations. For each patient, the standard deviation of the background (calculated using triplicates) will be computed, and a positive will be defined as greater than two times this value.

Rockefeller University

Memorial Sloan Kettering Cancer Center

Musculoskeletal Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Arthralgia

Breast Diseases

Joint Diseases

Pain

Neurologic Manifestations

Other Dietary Supplements

Aromatase Inhibitors

Omega 3 Fatty Acid

Patients receive omega-3 fatty acid supplementation PO QD for 6 months.

Patients receive placebo PO QD for 6 months.

Omega-3 Fatty Acid

Placebo

Nicole Williams, MD

This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.

PRIMARY OBJECTIVES:

I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).

SECONDARY OBJECTIVES:

I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response.

OUTLINE: Patients are randomized to 1 of 2 groups.

Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months.

Group II: Patients receive placebo PO QD for 6 months.

After completion of study, patients will be followed up periodically.

Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation

The relationship between RBC n-3 PUFA levels, inflammatory blood markers and the joint symptoms evaluated by the patient symptom assessment instruments. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pairwise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.

Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.

An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.

Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores.

The rates of adherence to and discontinuation of AI therapy will be recorded. Reasons for treatment discontinuation will be described. In addition, the investigators will also examine the compliance rates with n-3 PUFA or placebo supplements with pill counts at each visit and with a patient recorded medication calendar.

A sequential analysis of the data that allows filtering of extraneous SNPs and select SNP loci, identification and creation of predictive SNP clusters, and then evaluation of the networks' potential clinical and biological validity will be performed.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Cemiplimab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab

Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab

Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo

Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks

Fianlimab

Cemiplimab will be administered by IV infusion Q 3 weeks

Pembrolizumab will be administered by IV infusion Q 3 weeks

Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Clinical Trials Administrator

Clinical Trial Management

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab.

The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.

The study is looking at several other research questions, including:

* What side effects may happen from receiving the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
* How administering the study drugs might improve quality of life.

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.

Time between the date of randomization and the date of the first distant metastasis.

Time from randomization to the date of death.

A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.

An SAE is any untoward medical occurrence that at any dose:

* Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger).
* Is life-threatening
* Requires in-patient hospitalization or prolongation of existing hospitalization.
* Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect.
* Is an important medical event

An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it

A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.

As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher)

The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.

The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.

Immunogenicity will be characterized per drug molecule by ADA and NAb status.

The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.

The EQ-5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).

The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".

The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma	NCT01456104	Melanoma	Langerhans-type...	-	Memorial Sloan Kettering Cancer Center
Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma	NCT01456104	Melanoma	Langerhans-type...	-	Memorial Sloan Kettering Cancer Center
Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer	NCT02831582	Arthralgia Breast Neoplasm...	Omega-3 Fatty A... Placebo	18 Years -	Ohio State University Comprehensive Cancer Center
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery	NCT05608291	Melanoma	Fianlimab Cemiplimab Pembrolizumab Placebo	12 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for stage iib

Every month we try and update this database with for stage iib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stage iib

Every month we try and update this database with for stage iib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stage iib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.