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Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma

Smoldering Plasma Cell Myeloma

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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 daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

Carmel, Indianapolis +more, IN18+ yrsAll genders
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Evaluating Tolerability of ePUHRT With Brachytherapy Boost

Prostate Cancer

The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

Indianapolis, IN18+ yrsMen
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Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

Hematuria - Cause Not Known

This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients. Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine. This study is conducted to find out if the use of "Cxbladder Triage Plus" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called "Triage Plus". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients. The study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Triage Plus result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy. For test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Triage Plus result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. The survey has only one question. It is asking for the reasons of the decision. After making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months. To see how Triage Plus changes the number of cystoscopies, these will be counted in each group and then compared.

Merrillville, IN18–88 yrsAll genders
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Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

Acute Myeloid Leukemia

This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML. ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.

Crown Point, IN18+ yrsAll genders
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PSMA-PET to Guide Prostatectomy

Prostate Cancer

In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.

Indianapolis, IN40–80 yrsMen
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A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma

Basal Ganglia Germinoma · Diabetes Insipidus · Germinoma

This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.

Indianapolis, IN3–29 yrsAll genders
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Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

Prostate Adenocarcinoma · Stage III Prostate Cancer AJCC v8 · Stage IVA Prostate Cancer AJCC v8

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Goshen, IN18+ yrsMen
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Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

Locally Advanced/Metastatic Solid Tumors

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.

Indianapolis, IN18+ yrsAll genders
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A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Metastatic Castration-resistant Prostate Cancer (mCRPC) · Prostatic Neoplasms

The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Carmel, IN18+ yrsAll genders
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A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

Lung Cancer, Non-small Cell · Lung Cancer Metastatic · Solid Tumor, Adult

The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies. This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707. Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase. Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks. All subjects will be treated until tumor progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.

Indianapolis, IN18+ yrsAll genders
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Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment

Grade 3b Follicular Lymphoma · High Grade B-Cell Lymphoma · High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements

This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.

Crown Point, Dyer +more, IN18+ yrsAll genders
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Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia · Ann Arbor Stage I Lymphoma

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

Richmond, IN40–75 yrsAll genders
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A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Relapsed/Refractory Follicular Lymphoma · Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug in combination with lenalidomide * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality-of-life and ability to complete routine daily activities

Indianapolis, IN18+ yrsAll genders
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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Triple Negative Breast Cancer

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Indianapolis, Lafayette +more, IN18+ yrsAll genders
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Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers

Pancreatic Neoplasm

The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.

Indianapolis, Richmond, IN50–75 yrsAll genders
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A Study of VET3-TGI in Patients With Solid Tumors

Solid Tumor, Adult · Microsatellite Stable Colorectal Cancer · Head and Neck Squamous Cell Carcinoma

VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).

Indianapolis, IN18+ yrsAll genders
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