Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

Date Added
May 9th, 2023
PRO Number
Pro00126917
Researcher
Daniel Reuben

List of Studies


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

The primary trial objective is to see if the study drug called BI 907828 may help people with dedifferentiated liposarcoma (DDLPS) and is better than the approved drug, doxorubicin.
Additional trial goals are to find an optimal dose of BI 907828
and to determine whether BI 907828 improves the response
rate, duration of response, overall survival, disease control rate, the tolerability and if the study drug has a positive impact on the quality of life, compared to doxorubicin.

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

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (RELATIVITY 098)

Date Added
June 1st, 2022
PRO Number
Pro00116818
Researcher
Daniel Reuben

List of Studies


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

This study is for patients that have been diagnosed with stage III-IV Melanoma after a complete resection (no evidence of disease). The investigational drug in this study is relatlimab in combination with nivolumab. Investigational means the drug is not approved by the United States Food and Drug Administration (US FDA). Participants will be assigned to receive relatlimab with nivolumab in a fixed dose combination (FDC, both drugs in a single vial) or nivolumab alone, administered by intravenous (IV) infusion, meaning the drug is a solution given through a vein. The infusion is planned to take 30 minutes. Neither the participants or study doctor will know what is being administered.

This study is designed to explore if treating stage III-IV resectable melanoma patients with this combination, after they have surgery to remove all tumors, will reduce the probability of having progressive disease when compared to nivolumab alone, as well as to assess the possible side effects that this combination therapy might have. Participants can expect to be on this study for a minimum of 6 years.

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



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