Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
Recruiting
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions betwe... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Indiana University Simon Cancer Center, Indianapolis, Indiana
Conditions: Acute Myeloid Leukemia
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Recruiting
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pem... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Fort Wayne Medical Oncology and Hematology ( Site 0034), Fort Wayne, Indiana
Conditions: Small Cell Lung Cancer
Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)
Recruiting
Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana
Conditions: Non-small Cell Lung Cancer
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
Recruiting
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
Gender:
All
Ages:
Between 12 years and 80 years
Trial Updated:
11/30/2023
Locations: Research Site, Brownsburg, Indiana
Conditions: Asthma
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Recruiting
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
11/30/2023
Locations: Fort Wayne Neurological Center, Fort Wayne, Indiana
Conditions: Relapsing Multiple Sclerosis
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
Recruiting
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: Pembrolizumab with concurrent... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Fort Wayne Medical Oncology and Hematology ( Site 0094), Fort Wayne, Indiana
Conditions: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
Recruiting
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 evaluable participants. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluatio... Read More
Gender:
All
Ages:
Between 18 years and 50 years
Trial Updated:
11/30/2023
Locations: Indiana University School of Medicine - Infectious Diseases, Indianapolis, Indiana
Conditions: Gonococcal Infection
Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
Recruiting
This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high pr... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Community Cancer Center South, Indianapolis, Indiana
Conditions: Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Recruiting
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's im... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Reid Health, Richmond, Indiana
Conditions: Bladder Urothelial Carcinoma In Situ, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Invasive Bladder Mixed Carcinoma
TRC-PAD Program: In-Clinic Trial-Ready Cohort
Recruiting
The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstud... Read More
Gender:
All
Ages:
Between 50 years and 85 years
Trial Updated:
11/30/2023
Locations: Indiana University, Indianapolis, Indiana
Conditions: Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease, Dementia
Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
Recruiting
This phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, o... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/30/2023
Locations: Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana
Conditions: Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
Recruiting
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's diseas... Read More
Gender:
All
Ages:
Between 55 years and 90 years
Trial Updated:
11/30/2023
Locations: Indiana University, Indianapolis, Indiana
Conditions: Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)