A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination With Nivolumab In Patients With Advanced Solid Tumors

Date Added
October 12th, 2021
PRO Number
Pro00114862
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with non-small cell lung cancer. The investigational drug in this study is Ozuriftamab Vedotin (BA3021). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Ozuriftamab Vedotin by intravenous (IV) infusion. The purpose of this study is to see how Ozuriftamab Vedotin alone, and in combination with another drug called nivolumab, affects growth and formation of tumors; to see how safe Ozuriftamab Vedotin is alone and in combination with nivolumab; to understand how the body absorbs and processes Ozuriftamab Vedotin; to understand whether Ozuriftamab Vedotin, alone or in combination with Nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body) which may prevent the study drug from working and/or increase your risk of side effects. Participants can expect up to 75 clinic visits over a period of about 3 years.

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

A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients with MET Overexpressing Advanced Cancer

Date Added
November 23rd, 2021
PRO Number
Pro00115889
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer (NSCLC) and have a certain protein, called MET in their tumor. The investigational drug in this study is REGN5093-M114 (study drug). The study drug works by bringing chemotherapy to the cells that express MET protein to kill those cells and not the other tissues in your body. The aim of the study is to see how safe, tolerable (how your body reacts to the drug), and effective the study drug is. Participants will receive the study drug intravenously (in your vein) every 3 weeks for as long as they tolerate the drug well and the cancer is stable or responding to the study drug. There is then 2 follow up visits 30 and 90 days after the last dose of study drug and telephone calls every 30 days until the study ends.

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

A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination with AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)

Date Added
January 11th, 2022
PRO Number
Pro00115977
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with small cell lung cancer (SCLC). The investigational drug in the study is AMG 757. Both drugs are immunotherapy treatments, medicines that work with your immune system to help fight cancer. AMG 757 will be given in a liquid form directly into participants' veins (intravenously). This study is being done to find out about the safety and efficacy (effects good or bad) of AMG 757 for the treatment of SCLC. Participants can expect to receive treatment for about 24 months.
The duration of AMG 757 treatment will depend on how the disease responds to the investigational drugs and how the body tolerates AMG 757. So, participation may be longer or shorter than this window. The study period includes screening period lasting up to 21 days, a treatment period, a first safety follow-up visit, and a second safety follow-up visit. This will be followed by long-term follow-up visits up to 1 year from the first dose of AMG 757 for a total of about 3 years in the study.

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

Unbiased Discovery and Validation of Serum Auto-Antibodies in Patients with Rheumatic Immune-Related Adverse Events Due to Immune Checkpoint Inhibitors

Date Added
January 18th, 2022
PRO Number
Pro00117791
Researcher
John Wrangle

List of Studies


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

This study is for subjects that have been diagnosed with cancer, as well as healthy research subjects. The purpose of this study is to evaluate the risk factors for development of immune related adverse side effects from cancer immunotherapy and to evaluate differences from healthy research subjects. Participation in the study will take about 2 visits over a period of 6 months.

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

DNA EVALUATION OF FRAGMENTS FOR EARLY INTERCEPTION - LUNG CANCER TRAINING STUDY (DELFI-L101 STUDY)

Date Added
March 1st, 2022
PRO Number
Pro00116049
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this study is to collect blood samples to determine if a blood-based test can be used to identify lung cancers that may or may not also be seen on images of lungs. Additionally, the study aims to see if a blood-based test can identify other types of cancers and health conditions.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

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

Neuroendocrine Tumors Patient Reported Outcomes (NET-PRO)

Date Added
August 23rd, 2022
PRO Number
Pro00120896
Researcher
William Lancaster

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Lung
Summary

The purpose of this research study is to gain patient feedback around their Neuroendocrine tumor (NET) diagnosis, including symptoms and quality of life with different NET treatments, factors that influence the order of treatments given, and how the order of NET treatments affect patient's quality of life, symptoms and survival. The main eligibility criteria for this study are being 18 or older and receiving the diagnosis of a neuroendocrine tumor on or after January 1st, 2019. Participation will last about 18 months, involving the completion of four electronic or paper surveys spaced six months apart. The first survey will take about 40 minutes to complete, while the other three surveys may take about 20 minutes each to complete. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Eryn Beal
(843) 792-7011
bealery@musc.edu

Mental Fatigue and Self-Care in Informal Oncology Caregivers: A Descriptive Mixed Methods Study

Date Added
October 7th, 2022
PRO Number
Pro00122174
Researcher
Megan Wayne

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Mental Health, Non-interventional
Summary

This study is for anyone 18 years or older who provides unpaid care for a loved one living with cancer outside of the hospital setting. The purpose of this study is to help future caregivers and patients by learning how mental fatigue affects caregivers of persons living with cancer and determine if mental fatigue, participating in self-care activities, and general caregiver quality of life are related. Informal caregivers will be invited to complete a confidential, online survey that takes between 25 and 35 minutes to finish. Caregivers who complete the survey may be contacted and asked to participate in a 45-60 minute follow up interview either online or via phone if they are interested. The results of this study will help guide future research to identify ways healthcare professionals can help caregivers handle the stresses of caregiving and provide the best care possible to their loved ones at home.

Institution
MUSC
Recruitment Contact
Megan Wayne
8433070366
wayneme@musc.edu

LCCC 2047: A Phase II Trial of Induction and Maintenance Pembrolizumab and Olaparib in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Date Added
November 22nd, 2022
PRO Number
Pro00122497
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with locally advanced head and neck squamous cell carcinoma. The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for treatment of different cancers including lung, head and neck, breast and prostate cancer. However, FDA has not approved use of these two drugs together in treating head and neck cancer.

Treatment will be offered in three phases. In the induction phase, participants will receive a single infusion of pembrolizumab and will take olaparib tablets twice daily for total of 21 days. Participants will move to the chemoradiation phase, where they will receive radiation therapy and chemotherapy per routine standard care, for a total of 7 weeks. Chemoradiation therapy is done on a daily basis (excluding weekends), and chemotherapy therapy will involve a cisplatin infusion once weekly. At the conclusion of this phase, participants start the maintenance phase, which involves treatment with pembrolizumab and olaparib in cycles that are 42-days long. Treatment will include a single pembrolizumab infusion during each cycle and taking olaparib tablets twice daily during each cycle. Total number of cycles to be completed in the maintenance phase are 8 cycles. Participants can expect to be in this study for about 6.5 years.

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

A Phase 3, Open-label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Date Added
February 27th, 2023
PRO Number
Pro00124906
Researcher
Mariam Alexander

List of Studies

Keywords
Lung
Summary

This is a 2 Part, Phase 3, open-label, randomized study to sequentially demonstrate the pharmacokinetic noninferiority of amivantamab SC-CF administered via manual injection compared with amivantamab IV (Part 1) and the bioequivalence of amivantamab SC-CF administered via a manual injection versus amivantamab subcutaneous, co-formulated with recombinant human hyaluronidase, and delivered with an on-body delivery system (SC-CF OBDS; Part 2). The combination product of the device (on-body delivery system; OBDS) plus the study drug amivantamab SC-CF (hereafter referred to as amivantamab SC-CF OBDS) is provided as a completely assembled, ready to use, single-use product. It is preloaded with a prefilled liquid drug product vial, thereby eliminating the need for drug preparation by a pharmacist. The formulation of amivantamab SC-CF used in amivantamab SC-CF OBDS is identical to the manual injection formulation of amivantamab SC-CF (but differs from the IV formulation).

Lazertinib (JNJ-73841937) is an oral, highly potent, third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) with no demonstrated pharmacokinetic (PK) interaction with amivantamab. It selectively inhibits both activating EGFR mutations (Exon 19del, L858R) and the EGFR T790M resistance mutation
while showing mutant-selective activity for EGFR.

The primary objectives are to assess the pharmacokinetic noninferiority of amivantamab SC-CF via manual injection versus amivantamab IV (Part 1) and to assess the bioequivalence of amivantamab SC-CF via manual injection and amivantamab SC-CF OBDS (Part 2). Key secondary objectives are to assess efficacy (objective response rate [ORR] and progression-free survival [PFS]) and safety of the different administrations.

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



-- OR --