Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.

Assess the relationships between UV camera score, silicone mold of a skin patch, phenotypic evaluation and sun-exposure behaviors. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.

Determine the relationship between measures of sun exposure and genomic characteristics of tumors in melanoma patients. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.

This is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks.

UV Counseling

Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.

UV Photo

Biological Sample

Neil Box, PhD

This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.

Patients will have the opportunity to participate in a questionnaire and then they are given the option to participate in substudy A (wear a UV dosimeter, complete questionnaires, and receive feedback based on the UV dosimeter results), subtstudy B (wear a skin patch, participate in a UV photo analysis, answer questionnaires), and/or substudy C (give biological samples via nevi).

Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma

A short questionnaire is administered during the clinic visit to assess sun exposure behaviors of melanoma patients. The data gathered from this questionnaire will help identify possible trends in sun exposure behaviors and provide a baseline dataset for future research,

Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.

Determine whether UV exposure and camera scores correlates with UV signature (somatic) mutations and other tumor-related mutations in clinically benign nevi and primary melanomas using saliva samples, benign nevi, and primary melanomas. Next Generation Sequencing (NGS) will be used to obtain the genetic information from all samples.

Determine self-reported sun exposure behaviors through participant interviews. Questions are related to time spent outside, and what attempts to be sun-safe occurred while outside.

Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation

University of Colorado, Denver

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Kidney Diseases

Carcinoma

Colorectal Neoplasms

Breast Neoplasms

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Colonic Neoplasms

Urinary Bladder Neoplasms

Intestinal Neoplasms

Urologic Neoplasms

Urologic Diseases

Urinary Bladder Diseases

Urogenital Neoplasms

Kidney Neoplasms

Breast Diseases

Neoplasms, Glandular and Epithelial

Genital Diseases

Prostatic Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Herbal and Botanical

Vaccines

Cola

Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period.

Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.

Three EP injections of V934 (HD), 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.

Five EP injections of V934 (HD), 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.

A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10\^9 vector genomes/mL) or a HD (1 x 10\^11 vector genomes/mL).

V935

A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).

V934-EP

This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.

Two vaccines will be administered: V934-electroporation (EP) either low dose (LD) or high dose (HD), and V935 either LD or HD. In Part A, participants will be assigned to V935 vaccine alone or in combination with V934-EP. Part B will be an optional part of the study, offering V934-EP vaccine booster to participants who were enrolled in Part A.

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors

DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.

This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.

An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.

Merck Sharp & Dohme LLC

Participants who completed Part A had the option to enter Part B.

Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Part A: V935 LD

Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.

Part A: V934 LD(3)+V935 LD

Part A: V935 HD

Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Part A: V934 HD(3)+V935 HD

Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Part A: V934 HD(5)+V935 HD

Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V935 LD/V934 Booster

Part B: V934 LD(3)+V935 LD/V934 Booster

Part B: V935 HD/V934 Booster

Part B: V934 HD(3)+V935 HD/V934 Booster

Part B: V934 HD(5)+V935 HD/V934 Booster

Total

Age, Continuous

Sex: Female, Male

Senior Vice President, Global Clinical Development

Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.

Number of Participants With Dose-Limiting Toxicity (DLT)

All Participants as Treated (APaT) population; all participants who received at least one vaccination.

Number of Participants With Adverse Events (AEs)

Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.

Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.

Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)

Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.

Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.

Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma	NCT03783325	Nevi and Melano...	UV Counseling UV Photo Biological Samp...	18 Years -	University of Colorado, Denver
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)	NCT00753415	Non-Small Cell ... Breast Cancer Melanoma Upper GI Tract ... Colon Carcinoma Renal Cell Carc... Bladder Carcino... Prostate Cancer	V935 V934-EP	18 Years -	Merck Sharp & Dohme LLC
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma	NCT03783325	Nevi and Melano...	UV Counseling UV Photo Biological Samp...	18 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for nevi and melanomas