A Phase 3, Open-Label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly Diagnosed, MGMT Unmethylated Glioblastoma

Date Added
October 22nd, 2025
PRO Number
Pro00141541
Researcher
Alicia Zukas

List of Studies

Keywords
Cancer, Cancer/Brain, Men's Health, Women's Health
Summary

This is a Phase 3 study. Phase 3 studies can involve testing a study drug in hundreds to thousands of people over several years. The main purpose of this study is to see if the study drug, Niraparib, works better than the comparator drug in people who have just been diagnosed with glioblastoma. The comparator drug is a type of chemotherapy commonly used to treat newly diagnosed glioblastoma.
This study includes:
• Phase 1, where subjects will take either the study drug or comparator drug. All participants will also receive radiotherapy in this phase. In this phase, there will be about 45 visits to the study center. The duration for this phase will last as long as the cancer does not get worse.
• Phase 2, where subjects will continue with the same drug given in Phase 1 without radiotherapy. In this phase there will be about 53 visits to the study center and participation in the study will last for 42 weeks.
There are four periods of the study, the screening period (last about 1 month), study treatment period (as long as desired or up to 8 months), safety follow-up period (1 month), and long-term follow up period (up to 5 years).
Some procedures in this study are blood tests, memory, speech and thinking test, ECG, tissue sample, bone marrow biopsy, and imaging test. Some risks include the cancer could get worse and there are risks associated with the study drugs (for example, low appetite, difficulty speaking, headaches, vomiting, nausea, diarrhea, etc.)

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hccclinicaltrials@musc.edu

Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Date Added
October 7th, 2025
PRO Number
Pro00146363
Researcher
Jason Newman

List of Studies

Keywords
Cancer
Summary

This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4)

Date Added
October 3rd, 2025
PRO Number
Pro00145467
Researcher
Anthony Dominick

List of Studies

Keywords
Cancer
Summary

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9300
salzers@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu

Examining emotional health and symptom needs in long-term cancer survivors living with likely incurable cancer: Administrative Supplement to IMPACT R01

Date Added
October 1st, 2025
PRO Number
Pro00147156
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer
Summary

The aim of this supplement study is to learn more about the emotional health and symptom needs of long-term cancer survivors (over 5 years since diagnosis) living with likely incurable disease. Participants in this qualitative substudy will be individuals who are long-term cancer survivors who participated in another study of depression in individuals with likely incurable cancer. We will recruit long-term cancer survivors with likely incurable cancer to participate in one-time, 45- to 60-minute in-depth, semi-structured interviews. We will ask patients about emotional health and symptom burden concerns and elicit attitudes toward digital mental health interventions (DMHI) and preferences for intervention type and delivery. Findings will inform the development of digital mental health interventions tailored to this patient population.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Kathryn Moody
8437929698
moodykat@musc.edu



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