Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Nivolumab

Antineoplastic Agents, Immunological

One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.

One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.

One dose of Nivolumab 480mg given four weeks prior to surgical resection.

Nivolumab 480mg and surgical resection

Tanguy Lim-Seiwert, MD

Nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).

This research is being done to see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). Patients with recurrent disease may have a limited number of sites of metastatic (spread) squamous cell carcinoma of head and neck. Another goal of this study is to learn how nivolumab impacts the immune system's ability to treat the cancer. While nivolumab is approved by the U. S. Food and Drug Administration (FDA) for the treatment of patients with metastatic SCCHN with progression on or after platinum-based chemotherapy, the word "investigational" in this context means that the study drugs are not approved by the FDA for the treatment of head and neck cancers prior to surgery and thus is still being tested in research studies. However, the FDA is allowing the use of nivolumab in this study.

This study will have two arms. Cohort (arm) 1 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN. Twelve patients will be enrolled to this arm. Cohort 2 will examine one dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred and possibly spread to distant sites, but still can be resected with one surgery. Twelve patients will be enrolled to this arm.

The study will accrue to 2 cohorts, each of which consists of about 12 patients. If enrollment on 1 cohort is significantly faster, the lesser enrolling cohort number of patients may be decreased in favor of the better enrolling cohort to keep the total number of evaluable patients at 24 patients.Total of 24 patients will be accrued to the study.

Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN

Preoperative Immune Checkpoint Inhibitor Therapy for Patients With Primary Untreated or Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)

Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)

Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than \> 28 days from pre-planned day 0.

Number of participants with \< 10% residual tumor in the resection specimen.

Number of months until radiologic or clinical progression or death, whichever occurs first.

Number of participants with response as determined by RECIST version 1.1 and immune-related response criteria (irRC). Per RECIST criteria, Complete response (CR) is a disappearance of all target lesions, Partial response (PR) is \>= 30% decrease in the sum of the largest diameter (LD) of target lesions, Progressive disease (PD) is \>= 20% increase in the sum of the LD of target lesions.

Per irRC, immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a 25% increase in tumour burden from the lowest level recorded.

Bristol-Myers Squibb

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Melanoma

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Pembrolizumab

Dose cohorts of 3 participants each will be treated. Initiation of dosing will be staggered by at least 4 weeks for participants in the first cohort, also known as intra-cohort staggering.

Two dose levels of ADXS-NEO will be explored: 1 x 10\^9 and 1 x 10\^8 colony forming unit (CFU).

Two dose levels of ADXS-NEO will be explored (i.e., 1 x 10\^8 and 5 x 10\^8 CFU) in combination with 200 mg of pembrolizumab.

ADXS-NEO will be explored at 1 x 10\^8 CFU in combination with 200 mg of pembrolizumab in an expansion cohort.

ADXS-NEO

This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in participants with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).

Mutation-derived tumor antigens, which are often unique to each participant's tumor, represent a new source of targets for cancer immunotherapy. These mutations, which arise during tumorigenesis, are expressed only by the tumor and, as such, may be recognized as newly formed antigens, or neoantigens, by the participant's T cells. The lack of expression of participant-specific tumor mutations in nonmalignant cells suggests that vaccines targeting these tumor mutations have a low risk of autoimmunity and may represent a safer therapeutic approach than many of those currently available. The development of a Listeria monocytogenes (Lm)-based vaccine that expresses these participant-specific tumor antigens and that activates tumor-killing T cells has the potential to be a highly effective form of immunotherapy. In addition, the Lm platform, because it mediates tumor control through multiple mechanisms, may exhibit more robust anti-tumor activity than other vaccine platforms. Thus, the targeting of participant-specific mutation-derived tumor antigens and the concurrent stimulation of host immunity provides a rational approach for boosting anti-tumor immunity, as monotherapy and in combination with anti-programmed cell death protein-1 (PD-1) inhibitors.

Personalized immunotherapy treatment design

A Study of ADXS-NEO Expressing Personalized Tumor Antigens

A Phase 1 Dose-Escalation Study of ADXS-NEO Expressing Personalized Tumor Antigens, Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors

Advaxis, Inc.

Digestive System Diseases

Mouth and Tooth Diseases

Esophageal Neoplasms

Mouth Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Mouth Diseases

Stomatognathic Diseases

Esophageal Cancer

Oral Cancer

Vasodilator Agents

Urological Agents

Immunomodulating Agents

Tadalafil

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Tadalafil for up to 12 months and pembrolizumab for up to 24 months.

Khushbu Singh

Joseph Califano

This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.

Immune competent animal models of HNSCC demonstrate that combination PDE-5 inhibitor (tadalafil) and PD-1 inhibitor therapy is more effective than either therapy alone based on the concept of targeting multiple immune repressive abnormalities simultaneously (PD-1 checkpoint and myeloid suppressive pathways).

This trial will test the hypothesis that combination PD-1 inhibition and PDE-5 inhibition can be safely co-administered, and secondarily test the hypothesis that the combination of both therapies will be more effective than PD-1 inhibition alone in recurrent/metastatic HNSCC.

Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

A Phase II Study of Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Rate of dose limiting toxicity at least possibly attributable to study treatment

Overall survival at 12 months post-enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN	NCT03878979	Head and Neck S... Head and Neck C... Head and Neck C...	Nivolumab 480mg...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Study of ADXS-NEO Expressing Personalized Tumor Antigens	NCT03265080	Colon Cancer Me... Head and Neck C... Metastatic Non-... Urothelial Carc... Metastatic Mela...	ADXS-NEO Pembrolizumab	18 Years -	Advaxis, Inc.
Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer	NCT03993353	Head and Neck C... Head and Neck S... Head and Neck C... Head and Neck C... Head and Neck C... Head and Neck C... Cancer Cancer of Esoph... Cancer, Metasta... Cancer of Head ... Cancer of Mouth Cancer of Neck	Pembrolizumab Tadalafil	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for head and neck cancer metastatic