Clinical Trials in Oncology
SEMA4D is expressed by many tumor cells as well as by other cells in the tumor microenvironment. Evidence suggests that SEMA4D expression is correlated with tumor aggression and poor prognosis in cancer patients and appears to block immune cell infiltration and activity in tumors.
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Vaccinex is investigating pepinemab treatment in combination with immunotherapy in solid tumors such as melanoma, head & neck cancer and breast cancer.
Note:Â Pepinemab (VX15/2503) is an investigational drug currently in clinical studies. It has not been demonstrated to be safe and effective for any disease indication. There is no guarantee that pepinemab (VX15/2503) will be approved for the treatment of any disease by the U.S. Food and Drug Administration or by any other health authority worldwide.
View Trial on ClinicalTrials.gov
National Trial Reference Number
 Active, Not RecruitingÂ
This study evaluated pepinemab (VX15/2503) in combination with cancer immunotherapy in patients with melanoma. The goal was to better understand the treatment’s safety, side effects, and potential effectiveness, as well as how it may help the immune system recognize and fight cancer.
Biomarker Trial - Melanoma
Immunotherapy in Resectable Stage IIIB-D Melanoma
Investigator initiated in collaboration with Emory University
Pepinemab in combination with nivolumab and/or ipilimumab appeared to increase tumor-infiltrating B cells and CD4+ T cells within tumor microenvironment, when compared to nivolumab alone. These immune cells appeared to be organized into tertiary lymphoid structures (TLS) which are associated with improved immunotherapy response rates.
Breast Cancer - Cell Therapy
Investigator initiated in collaboration with the H. Lee Moffit Cancer Center and Research Institute
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients with Metastatic HER2+ Breast Cancer
View Trial on ClinicalTrials.gov
National Trial Reference Number
 Active, Not RecruitingÂ
This Phase 1 trial will evaluate the safety and tolerability of pepinemab in combination with a Dendritic Cell vaccine and trastuzumab in patients with HER2 positive breast cancer.
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Investigators hypothesize these therapies will elicit CD4+ HER2 specific T cell responses. HER2 specific T cells will be expanded ex-vivo which will be subsequently infused into patients following lymphodepletion therapy with cyclophosphamide. Trastuzumab and pepinemab will be given as maintenance therapy in addition to booster DC1 vaccines.
Pre-clinical studies performed at the H. Lee Moffit Cancer Center and Research Institute have shown improved tumor control in mice treated with DC vaccines and anti-SEMA4D.Â
KEYNOTE B84
Pepinemab in Combination with Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
In collaboration with Merck Sharp & Dohme Corporation
The purpose of the study was to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Biomarker Trial - Head & Neck CancerÂ
Immunotherapy in Stage I-IVA resectable head and neck squamous cell cancer
Investigator initiated in collaboration with Emory University
View Trial on ClinicalTrials.gov
National Trial Reference Number
 Active, Not RecruitingÂ
This phase I trial studied safety and immune changes of anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may impact the immune response to interfere with the ability of tumor cells to grow and spread.
The purpose of this study was to evaluate the safety and tolerability of IV administration of VX15/2503 in combination with a fixed dose of avelumab in patients with advanced non-small cell lung cancer. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) of VX15/2503 administered in combination with avelumab.
CLASSICAL-Lung
Pepinemab in Combination with Avelumab in Advanced Non-Small Cell Lung Cancer (CLASSICAL)
In collaboration with Merck KGaA/ EMD Serono
This phase Ib/II study to evaluate the safety, tolerability, and efficacy of pepinemab in combination with avelumab in 62 patients with advanced non-small cell lung cancer (NSCLC) has been completed. The main objectives were to evaluate safety/tolerability, establish a recommended phase 2 dose (RP2D), obtain a preliminary evaluation of antitumor activity, and investigate candidate biomarker activity. Results were reported in Clinical Cancer Research.
Pancreatic Adenocarcinoma
Pepinemab in Combination with Avelumab for Metastatic Pancreatic Adenocarcinoma
In collaboration with Merck KGaA & the University of Rochester
View Trial on ClinicalTrials.gov
National Trial Reference Number
 Active, Not RecruitingÂ
This trial assessed the safety and tolerability of Pepinemab in combination with Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed after first line chemotherapy. Phase 2 will assess the efficacy of this combination therapy.
Solid Tumors in Pediatric Patients
Treating Younger Patients with Recurrent, Relapsed or Refractory Solid Tumors
In collaboration with the Children's Oncology Group in collaboration with the National Cancer Institute
This phase I/II trial studied the side effects and best dose of pepinemab (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after progression on prior treatment, or did not respond to prior treatment. Immunotherapy with monoclonal antibodies, such as pepinemab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
This study is now complete and was reported in Pediatric Blood Cancer.