A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
Recruiting
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: Research Site, New Albany, Indiana
Conditions: Breast Cancer
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Recruiting
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
Gender:
All
Ages:
Between 18 years and 99 years
Trial Updated:
11/29/2023
Locations: Ft Wayne Med Oncology Hematology, Fort Wayne, Indiana
Conditions: Melanoma
MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
Recruiting
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemi... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: Alliance for Multispecialty Research - Medisphere Medical Research Center ( Site 0080), Evansville, Indiana
Conditions: Arteriosclerosis, Hypercholesterolaemia
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Recruiting
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is bei... Read More
Gender:
All
Ages:
Between 2 years and 17 years
Trial Updated:
11/29/2023
Locations: Riley Hospital for Children /ID# 256454, Indianapolis, Indiana
Conditions: Crohn's Disease
A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Recruiting
The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: Synexus Clinical Research US - Evansville ( Site 0031), Evansville, Indiana
Conditions: Hypercholesterolemia, Familial Hypercholesterolemia
A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
Recruiting
The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: Synexus Clinical Research US - Evansville ( Site 0109), Evansville, Indiana
Conditions: Hypercholesterolemia, Familial Hypercholesterolemia
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Recruiting
This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may... Read More
Gender:
All
Ages:
45 years and above
Trial Updated:
11/29/2023
Locations: Research Site, Fort Wayne, Indiana
Conditions: Acute Coronary Syndrome
Topical Ruxolitinib Evaluation in Chronic Hand Eczema
Recruiting
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: The Indiana Clinical Trials Center Ictc, Plainfield, Indiana
Conditions: Hand Eczema
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Recruiting
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
Gender:
All
Ages:
Between 12 years and 100 years
Trial Updated:
11/29/2023
Locations: The Indiana Clinical Trials Center PC, Plainfield, Indiana
Conditions: Atopic Dermatitis
A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)
Recruiting
This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: Indiana University Melvin and Bren Simon Cancer Center ( Site 3011), Indianapolis, Indiana
Conditions: Metastatic Urothelial Carcinoma, Urothelial Neoplasms
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
Recruiting
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/29/2023
Locations: Lutheran Medical Group (301-010), Fort Wayne, Indiana
Conditions: COVID-19
A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis
Recruiting
The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of... Read More
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
11/29/2023
Locations: Fort Wayne Neurological Center, Fort Wayne, Indiana
Conditions: Relapsing Forms of Multiple Sclerosis