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A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Sep 2023 |
PRE-I-SPY Phase I/Ib Oncology Platform Program
QuantumLeap Healthcare Collaborative
HER2-positive Breast Cancer
Metastatic Cancer
Metastatic Breast Cancer
Metastatic
HER2-positive Metastatic Breast Cancer
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to
evaluate single agents or combinations in a metastatic treatment setting that may be
relevant for breast cancer patients with the overall goal of moving promising drug
regimens into the I-SPY 2 SMART Design Trial (NCT01042379)... expand
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner. Type: Interventional Start Date: Dec 2022 |
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting...
National Cancer Institute (NCI)
Recurrent Biliary Tract Carcinoma
Recurrent Distal Cholangiocarcinoma
Recurrent Gallbladder Carcinoma
Recurrent Intrahepatic Cholangiocarcinoma
Stage III Distal Bile Duct Cancer AJCC v8
This phase II ComboMATCH treatment trial compares the usual treatment of modified
leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib
plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that
have spread to other places in the body (advanced)... expand
This phase II ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting). Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by killing tumor cells. Leucovorin may help the other drugs in the mFOLFOX6 chemotherapy regimen work better by making tumor cells more sensitive to the drugs. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps to stop or slow the spread of tumor cells. Giving binimetinib in combination with mFOLFOX6 chemotherapy may be effective in shrinking or stabilizing advanced biliary tract cancers in the 2nd line setting. Type: Interventional Start Date: Feb 2024 |
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung...
Boehringer Ingelheim
Scleroderma, Systemic
This study is open to adults aged 18 and older or above legal age who have systemic
sclerosis. People can participate if they have a specific subtype called diffuse
cutaneous systemic sclerosis. People with another subtype called limited cutaneous
systemic sclerosis can also participate if they are... expand
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects. Type: Interventional Start Date: Nov 2022 |
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants...
Biogen
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus
on participants who have either active subacute CLE or chronic CLE, or both. They may
also have systemic lupus erythematosus (SLE).... expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70%? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks Type: Interventional Start Date: Sep 2022 |
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With...
Janssen Research & Development, LLC
Advanced or Metastatic Colorectal Cancer
The purpose of this study is to assess the anti-tumor activity of amivantamab as a
monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added
to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer
(mCRC) (Ph2 cohorts), and to assess the... expand
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts). Type: Interventional Start Date: Jul 2022 |
SPYRAL AFFIRM Global Study of RDN with the Symplicity Spyral RDN System in Subjects with Uncontrolled...
Medtronic Vascular
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
The purpose of this single-arm interventional study is to evaluate the long-term safety,
efficacy, and durability of the Symplicity Spyral system in subjects treated with renal
denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects
previously treated in... expand
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies. Type: Interventional Start Date: Oct 2021 |
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Endometrial Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
The purpose of this study is to find out whether the study drug, LY3537982, is safe and
effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients
must have already received or were not able to tolerate the standard of care, except for
specific groups who have not had... expand
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years. Type: Interventional Start Date: Jul 2021 |
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared...
AbbVie
Non Small Cell Lung Cancer
Cancer is a condition where cells in a specific part of body grow and reproduce
uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which
cancer cells form in the tissues of the lung. The purpose of this study is to determine
if telisotuzumab vedotin works better than... expand
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 300 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Mar 2022 |
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly...
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803,
an IL-15 superagonist, with or without combination broadly neutralizing antibodies
(bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI). expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI). Type: Interventional Start Date: May 2021 |
CERENOVUS Neurothrombectomy Devices Registry
Cerenovus, Part of DePuy Synthes Products, Inc.
Cerebral Stroke
A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large
Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in
acute ischemic stroke patients with confirmed intracranial vessel occlusion. expand
A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in acute ischemic stroke patients with confirmed intracranial vessel occlusion. Type: Observational Start Date: Sep 2018 |
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads...
University of Alabama at Birmingham
Decision Making, Shared
Family Caregiving
Chronic Kidney Disease
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the
purpose of this study is to pilot test, an optimization trial approach to develop and
refine the decision partnering skills of persons with stage 4 chronic kidney disease and
their caregivers. Using a 2x2x2 full... expand
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no). Type: Interventional Start Date: Sep 2024 |
Impairments That Affect Correct Inhaler Use in COPD
COPD Foundation
COPD
INHALE is a one-year, multi-site observational research study funded by Viatris, with two
aims:
1. Determine the prevalence of both cognitive impairment and impaired manual dexterity
in stable out-patients with chronic obstructive pulmonary disease (COPD).
2. Assess the relationship... expand
INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims: 1. Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD). 2. Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs. Type: Observational Start Date: Dec 2023 |
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic...
Cytokinetics
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
This clinical trial will study the effects of aficamten (versus placebo) on the quality
of life, exercise capacity, and clinical outcomes of patients with non-obstructive
hypertrophic cardiomyopathy. expand
This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Type: Interventional Start Date: Aug 2023 |
Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
National Alliance for Sickle Cell Centers
Sickle Cell Trait
The main purpose of this study is to create a longitudinal cohort of those with Sickle
Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS,
assess for differences in those with varying quantities of HbS and assess for potential
clinical complications of SCT. expand
The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT. Type: Observational Start Date: Apr 2023 |
The PEERLESS II Study
Inari Medical
Pulmonary Embolism
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever
System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute
PE. expand
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE. Type: Interventional Start Date: Nov 2023 |
Advancing Transplantation Outcomes in Children
National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant
This is a pediatric kidney transplant study comparing the safety and efficacy of an
immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate
Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups
within 24 hours following the transplant procedure.... expand
This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months. Type: Interventional Start Date: May 2024 |
A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body...
AbbVie
Human Immuno-deficiency Virus (HIV) Disease
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency
Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong
therapy. The purpose of this study is to assess change in disease activity, adverse
events, tolerability, and how the drug moves... expand
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. In Part 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). In Part 2, eligible participants will be placed in an open-label arm to receive Budigalimab. Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide. In Part 1, participants will receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. In Part 2, participants will receive 4 doses of open-label subcutaneous (SC) Budigalimab for a 6 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 112 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 112 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Oct 2023 |
Investigating the Use of TaVNS to Treat Insomnia in Individuals with Breast Cancer (taVNS-insomnia-BC)
University of Alabama at Birmingham
Breast Cancer
Insomnia
In the present study, the investigators aim to investigate feasibility of utilizing
noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to
address insomnia in patients with stage I-IV breast cancer. expand
In the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address insomnia in patients with stage I-IV breast cancer. Type: Interventional Start Date: Sep 2023 |
Study of Tazemetostat in Lymphoid Malignancies
University of Alabama at Birmingham
T-cell Lymphoma
Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients
with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for
an EZH2 mutation as detected by an FDA-approved test and who have received at least 2
prior systemic therapies, and for adult... expand
Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment option. We propose a study to evaluate the safety of tazemetostat in relapsed / refractory peripheral T-cell lymphoma. Type: Interventional Start Date: Sep 2024 |
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Tenax Therapeutics, Inc.
Pulmonary Hypertension
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with
placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6
MWD; Day 1 to Week 12). expand
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12). Type: Interventional Start Date: Jan 2024 |
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor...
Taiho Oncology, Inc.
Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in
patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and
other mutations. expand
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations. Type: Interventional Start Date: Jul 2023 |
Lupus Landmark Study: A Prospective Registry and Biorepository
Lupus Research Alliance
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Neuropsychiatric Systemic Lupus Erythematosus
The purpose of the registry and biorepository is to provide a mechanism to store clinical
data, linked biospecimens and molecular data to support the conduct of future research on
Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). expand
The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). Type: Observational [Patient Registry] Start Date: Jun 2023 |
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
Smith Giri
Multiple Myeloma
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo
Autologous Stem Cell transplantation at UAB. Participants will be randomized into either
a prehabilitation program or an attention control group before their transplant. The
primary outcomes will be feasibility and secondary... expand
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up. Type: Interventional Start Date: Jul 2023 |
Selinexor in Maintenance Therapy After Systemic Therapy for Participants with P53 Wild-Type, Advanced...
Karyopharm Therapeutics Inc
Endometrial Cancer
The purpose of this study is to evaluate the efficacy and safety of selinexor as a
maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have
achieved a partial response (PR) or complete response (CR) (per Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST v 1.1])... expand
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo. Type: Interventional Start Date: Apr 2023 |
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