Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

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

Temozolomide

Dacarbazine

Talimogene laherparepvec

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination occurs.

Subjects will receive (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination occurs.

PV-10 (10% rose bengal disodium)

Dacarbazine, temozolomide or talimogene laherparepvec

Eric Wachter, Ph.D.

Sanjiv Agarwala, M.D.

This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10).

Subjects in the comparator arm who have completed at least 1 cycle of study treatment and who meet the study protocol definition of disease progression but do not have evidence of visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10. Subjects crossing over must meet all study inclusion and exclusion criteria for clinical laboratories, thyroid function, concurrent or intercurrent illness and pregnancy at the time of crossover.

Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include increase in size and/or number of lesions, distant or nodal disease progression, or death. All secondary endpoints involving disease response and progression will be based on the IRC determination.

An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.

Blinded review by independent review committee (IRC) for primary and key secondary endpoints.

PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

In this exploratory endpoint, changes in Skindex-16 self-assessment scores were evaluated vs Day 1 baseline domain scores: symptom domain (items 1-4); emotional domain (items 5-11); and functioning domain (items 12-16). The Skindex-16 instrument solicits response to the extent of bother during the preceding week by 16 items (e.g., itching, hurting, worry, impact on daily activities), using a score from 0 (never bothered) to 6 (always bothered) for each item. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. A lower domain score at baseline signifies lower impact of that domain; a decrease in domain score from baseline signifies improvement in that domain. Median baseline score and change from baseline over the study interval is presented for each domain.

PFS was estimated via Kaplan-Meier analysis using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Subjects who did not have an event of progression or death were censored at their last assessment date.

Assessment of progression was performed by the sponsor based on review of lesion measurement and clinical progression data reported by each investigator. Events signaling progression included increase in size and/or number of study lesions, onset of visceral metastatic disease, and death. For target lesions (assigned prior to randomization), complete response (CR) required disappearance of all target lesions; partial response (PR) required \>= 30% decrease in sum of the longest diameter (SLD) of all target lesions; progressive disease (PD) required \>=20% increase in SLD of target lesions. Non-target lesions were followed for CR, PD, or non-CR/non-PD status using equivalent thresholds. Progression occurred when PD was observed in either target or non-target lesion.

CRR was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.

DCR was estimated via Kaplan-Meier analysis for participants achieving a complete response, and was defined as the interval from first complete response to disease progression or death; responders who did not have an event of progression or death were censored at their last assessment date. Complete response was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.

OS was documented at 12 week intervals commencing on withdrawal from active study participation. Documentation was made by subject clinic visit or other personal contact, telephonic contact, review of medical records, or other unequivocal evidence of survival status. OS was estimated via Kaplan-Meier analysis, and was defined as the interval from randomization to death; subjects who did not have an event of death were censored at their last assessment date.

Safety and tolerability were assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.

Provectus Biopharmaceuticals, Inc.

Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.

PV-10 (10% rose bengal disodium)

PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator

PV-10

Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.

Dacarbazine, temozolomide or talimogene laherparepvec

Chemotherapy or Oncolytic Viral Therapy

Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 was re-administered at 28-day intervals until complete response, disease progression or study termination.

Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Italy

France

Region of Enrollment

Disease burden was assessed at baseline to characterize melanoma disease stage according to the AJCC 2009 staging system, where stage (I-IV) is based on TNM classification: T refers to tumor size, N refers to lymph node involvement, and M represents metastasis (spread) to other parts of the body. The staging number represents a sum of the TNM classification: a lower stage (i.e., I or II) represents better the prognosis for the patient; the higher the stage (i.e., III or IV), the worse the prognosis.

Participants were not stratified according to stage.

American Joint Committee on Cancer (AJCC) Stage at Baseline

Planned accrual was 225 subjects. However, due to slow accrual during a period of rapid change in global drug development for cutaneous melanoma, the study was terminated early after 20 subjects initiated study treatment. Because the study was terminated prior to achievement of pre-specified efficacy thresholds, the planned central independent review was not conducted and the small number of subjects precluded formal analysis and scientifically meaningful interpretation of efficacy parameters.

Eric Wachter, Chief Technology Officer

Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.

Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.

Response data from one study center were censored due to resignation of the principal investigator.

Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of PFS.

Progression-free Survival (PFS)

Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.

Response data from one study center were censored due to resignation of the principal investigator.

Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of CRR.

Complete Response Rate (CRR)

Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.

Response data from one study center were censored due to resignation of the principal investigator.

Duration of Complete Response (DCR)

Subjects were analyzed according to treatment group assignment at randomization.

Overall Survival (OS)

PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator.

Number of Participants With Adverse Events

Baseline Symptom Domain Score

Change in Symptom Domain Score from Baseline

Baseline Emotional Domain Score

Change in Emotional Domain Score from Baseline

Baseline Functioning Domain Score

Change in Functioning Domain Score from Baseline

Subjects receiving PV-10 upon crossover from comparator are included in the analysis population for PV-10 (after crossover).

Response data from one study center were censored due to resignation of the principal investigator.

Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of Skindex data.

Change in Domain Scores From Baseline Using the Patient Reported Skindex-16 Instrument

PV-10 (10% Rose Bengal Disodium)

Chemotherapy or Oncolytic Viral Therapy (Dacarbazine, Temozolomide or Talimogene Laherparepvec)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

Hematinics

Vitamins

Antibodies

Gemcitabine

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Cisplatin

Cemiplimab

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Standard-of-care chemotherapy will administered from these options:

Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance

cemiplimab regimen as monotherapy as per study protocol

Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Patients will be administered cemiplimab as per protocol.

cemiplimab

Clinical Trial Management

The primary objectives of the study are:

* To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
* To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells

The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

There is option to join genomics sub-study.

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

PFS as assessed by a blinded IRC using RECIST 1.1.

The number of patients with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of patients in the efficacy analysis set

The BOR, as determined by the IRC per RECIST 1.1

Duration of response will be defined as the time between the date of first response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy or death due to any cause, whichever comes first

Number of patients with laboratory abnormalities

Sanofi

Regeneron Pharmaceuticals

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Capecitabine

Levoleucovorin

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Antidotes

Protective Agents

Trace Elements

Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.

Patients will receive mFOLFOX6 once every two weeks for 12 cycles as adjuvant chemotherapy or CapeOx once every three weeks for 8 cycles as adjuvant chemotherapy. Total 24 weeks.

mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150-165 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400-2800mg/m2 as a 46-48 hour continuous infusion on day 1)

mFOLFOXIRI

mFOLFOX6(oxaliplatin 85 mg/m2, folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-48 hour continuous infusion on day 1)

CapeOx(Oxaliplatin 130 mg/m2 intravenous infusion on day 1,Capecitabine 1000 mg/m2 twice daily PO for 14 days)

mFOLFOX6 OR CapeOx

Ye Lechi, M.D.

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

This trial is a two-arm, open labelled, prospective, randomized phase II studies. The postoperative stage of eligible patients was stage IIIB or stage IIIC. These high risk patients will be randomly assigned, in a 1:1 ratio, to receive either mFOLFOXIRI or mFOLFOX6/CapeOx for 6 months as adjuvant chemotherapy.

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research

Defined as the time from randomization to relapse or death, whichever occurred first

Defined as the time from randomization to death from any cause

First Affiliated Hospital of Wenzhou Medical University

Musculoskeletal Diseases

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma	NCT02288897	Cutaneous Melan...	PV-10 (10% rose... Dacarbazine, te...	18 Years -	Provectus Pharmaceuticals
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT03088540	Carcinoma，Non-S... Lung Carcinomas... Non-small-cell ... Nonsmall Cell L...	Pemetrexed Paclitaxel Gemcitabine Cisplatin Carboplatin cemiplimab	18 Years -	Regeneron Pharmaceuticals
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer	NCT05200299	Colorectal Canc...	mFOLFOXIRI mFOLFOX6 OR Cap...	18 Years - 75 Years	First Affiliated Hospital of Wenzhou Medical University
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
Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting	NCT03743766	Melanoma	Relatlimab Nivolumab Relatlimab + Ni...	18 Years -	University of Pittsburgh
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT03088540	Carcinoma，Non-S... Lung Carcinomas... Non-small-cell ... Nonsmall Cell L...	Pemetrexed Paclitaxel Gemcitabine Cisplatin Carboplatin cemiplimab	18 Years -	Regeneron Pharmaceuticals
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer	NCT00338247	Neoplasms, Brea...	lapatinib + cap...	18 Years -	Novartis
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.	NCT04381494	Unresectable St...	Multiparametric...	18 Years - 130 Years	AstraZeneca
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT03088540	Carcinoma，Non-S... Lung Carcinomas... Non-small-cell ... Nonsmall Cell L...	Pemetrexed Paclitaxel Gemcitabine Cisplatin Carboplatin cemiplimab	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for stage iiic

Every month we try and update this database with for stage iiic 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 iiic

Every month we try and update this database with for stage iiic 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 iiic 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.