MELANOMA AND SKIN CANCER
22.0189: A Phase 1/2, open-label study of PD-1 knockout tumor-infiltrating lymphocytes (IOV-4001) in participants with unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer
Principal Investigator: Jason Chesney, MD, PhD
Phase: I/II
Description: This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).
More info: https://clinicaltrials.gov/ct2/show/NCT05361174?term=NCT05361174&draw=2&rank=1
22.0406: An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; LN-144), for Patients with Unresectable or Metastatic Melanoma
Principal Investigator: Jason A Chesney, MD, PhD
Description: This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.
Learn more here: https://clinicaltrials.gov/ct2/show/NCT05398640?term=IOV-EAP-401&draw=2&rank=1
20.1176: A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma
Principal Investigator: Jason Chesney, MD, PhD
Phase: II
Description: DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
Learn more here: https://clinicaltrials.gov/ct2/show/NCT05050006?term=NCT05050006&draw=2&rank=1
19.1041: A Phase 4 Pan-Tumor Study of Long Term Follow up for Cancer Survivors treated with Nivolumab or Nivolumab Combination Therapy
Principal Investigator: Jason A Chesney, MD, PhD
Phase: IV
Description: Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.
More info: https://clinicaltrials.gov/ct2/show/NCT03899155?term=NCT03899155&draw=2&rank=1
18.1095: Neoadjuvant combination immunotherapy for stage III melanoma
Principal Investigator: Michael M Egger, M.D.
Phase: II
Description: Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.
More info: https://clinicaltrials.gov/ct2/show/NCT03842943?term=NCT03842943&draw=2&rank=1
19.0698: Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
Principal Investigator: Rebecca Redman, M.D.
Phase: I
Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
More Info: https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1
18.1191: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
Principal Investigator: Jason A Chesney, MD, PhD
Phase: II
Description: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03767348?term=NCT03767348&rank=1
17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies
Principal Investigator: Rebecca Redman, M.D.
Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.
Phase: I
Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1
18.0336: A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors
Principal Investigator: Jason A Chesney, MD, PhD
Description: A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.
Phase: II
Additional Information: https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1
16.0568 - Molecular Analysis for Therapy Choice (MATCH).
Principal Investigator: Vivek Sharma, M.D., F.A.C.P.
Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.
Phase: II
Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1
08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).
Principal Investigator: Rebecca Redman, M.D.
Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.