MELANOMA AND SKIN CANCER

21.0272:  A MULTICENTER, OPEN-LABEL, PHASE 2 STUDY OF INTRATUMORAL CMP-001 IN COMBINATION WITH INTRAVENOUS NIVOLUMAB IN SUBJECTS WITH REFRACTORY UNRESECTABLE OR METASTATIC MELANOMA

Principal Investigator: Jason Chesney, MD, PhD

Phase:  II

Description:  CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma. The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. The secondary objectives are to: To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. To evaluate the efficacy of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. To assess the pharmacokinetic (PK) profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. To assess and describe the immunogenicity of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma

More info:  https://clinicaltrials.gov/ct2/results?cond=&term=NCT04698187&cntry=&state=&city=&dist=

 

21.0285:  A RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROL, PHASE 2/3 STUDY OF FIRST-LINE INTRATUMORAL CMP-001 IN COMBINATION WITH INTRAVENOUS NIVOLUMAB COMPARED TO NIVOLUMAB MONOTHERAPY IN SUBJECTS WITH UNRESECTABLE OR METASTATIC MELANOMA

Principal Investigator: Jason Chesney, MD, PhD

Phase:  2/3

Description:  CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma.The study is divided into two phases: Phase 2 and Phase 3.The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma.The secondary objectives of Phase 3 are to:To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.

More info:  https://clinicaltrials.gov/ct2/results?cond=&term=NCT04695977&cntry=&state=&city=&dist=

 

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 

 

16.0817 - A Phase 2, Multicenter, Single-arm Study to Assess the Safetyand Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of Patients with Metastatic Melanoma.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  LN-144 is a cell transfer therapy and is based on current TIL therapy regimens originally developed by the NCI for the treatment of patients with metastatic melanoma. The cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients will be evaluated for response approximately 12 weeks following the LN-144 therapy. Patients will receive one course of treatment.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02360579?term=C-144-01&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.

 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1