24.0407:  Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma 

Principal Investigator: Jason Chesney, MD, PhD 

Phase:  II/III 

Description:  This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT02339571?term=NCT02339571&rank=1

24.0254:  A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen

 Principal Investigator: Jason Chesney, MD, PhD

 Phase:  III

 Description:  This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

 ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06264180?term=NCT06264180&rank=1

23.0726:  A Phase 1-2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants with Unresectable or Metastatic Melanoma Resistant to Checkpoint Inhibitors and After BRAF-MEK Targeting Therapy in Participants with BRAF Mutated Melanoma

Principal Investigator: Jason Chesney, MD, PhD 

Phase:  II 

Description:  This is a study to investigate the safety and efficacy of an investigational regimen, OBX-115, in adult participants with advanced/metastatic melanoma. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06060613?term=NCT06060613&rank=1

23.0630:  A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma. 

Principal Investigator: Jason Chesney, MD, PhD 

Phase:  III 

Description:  The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer [AJCC] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.

More Info:  https://clinicaltrials.gov/study/NCT05727904?term=NCT05727904&rank=1

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

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

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

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  

 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.