Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks

200mg every 3 weeks for 16 weeks given by IV infusion

IMRT 60-66Gy

Shlomo Koyfman, MD

A small group of skin cancers of the head and neck, called resected cutaneous squamous carcinomas, are more aggressive than most cancers of this type, even after being treated with standard therapy. This trial will use stronger treatment to look at the safety and effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a cancer has already been treated to suppress secondary tumor formation in high risk cutaneous squamous cell cancer of the head and neck.

Primary Objective To assess safety by looking at the people with dose limiting responses

Primary Objective:

To assess safety and estimate 1-year progression-free survival (PFS) of postoperative radiation therapy (RT) + concurrent and adjuvant Pembrolizumab in high risk resected cutaneous squamous cell cancer of the head and neck (cSCC-HN).

Secondary Objectives

1. To evaluate the relationship of baseline programmed death-ligand 1 (PD-L1) expression by tumor and tumor-infiltrating lymphocytes (TILs) to preliminary efficacy .
2. To phenotype tumor infiltrating lymphocytes and peripheral blood lymphocytes (PBLs), and investigate tumor suppressor populations including Tregs, myeloid-derived suppressor cells (MDSCs) and cluster of differentiation 8 (CD8) suppressor cells and assess ex vivo for effector function by cytokine production and cytotoxicity assays as well as suppressor function in assays with autologous PBLs.
3. To evaluate the tumor microenvironment (TME), and immune markers at the invasive margin of the tumor, including CD8, PD-1, PD-L1, TIM-3, galectin-9 or HMGB-1, BTLA and HVEM, as well as Lag-3, CTLA-4 and others.
4. To evaluate the genomic and/or transcriptomic profile of these tumors using RNA-seq /Whole Transcriptome Shotgun Sequencing

Trial Design:

This is a phase II trial evaluating the addition of concurrent and adjuvant fixed-dose pembrolizumab in combination with standard intensity-modulated radiation therapy (IMRT), in order to establish safety and estimate efficacy of this regimen to be tested in a subsequent randomized registration trial.

Thirty seven patients will be enrolled.

The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck

A Phase II Study of the Addition of Pembrolizumab to Postoperative Radiotherapy in Resected High Risk Cutaneous Squamous Cell Cancer of the Head and Neck

There will be an initial safety run in cohort consisting of an initial safety run in cohort consisting of eight patients to allow for at least six evaluable patients for dose limiting toxicities (DLTs) by the week 20 visit. If a total of 0-2 of the initial six evaluable patients experience DLTs, the safety run in will have been deemed successful and the 29 remaining planned patients will be accrued. DLT for this study is defined as the occurrence of a severe adverse event (AE) that is at least possibly related to pembrolizumab, and occurs from the initiation of treatment thru 30 days after the final administration of the study treatment

Progression-free survival (PFS) will be calculated from treatment initiation to disease progression or death from any cause or last follow up

Case Comprehensive Cancer Center

IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks

Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion

IMRT 60-66Gy: 60-66Gy for 6 weeks

Pembrolizumab + Post Operative Radiotherapy

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Shlomo Koyfman

Number of Subjects With Dose Limiting Toxicities

Participants enrolled in the study, excluding one participant who had disease progression prior to completing treatment.

Number of Participants With Progression Free Survival

Overall Study

Adenocarcinoma

Micronutrients

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Folfirinox

Tubulin Modulators

Antimitotic Agents

Antimetabolites

FOLFIRINOX:

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles over 8 weeks

Chemoradiation:

Radiation to begin no sooner than 28 days from last day of chemotherapy.

On Day 1(+ 2days to accommodate scheduling difficulties):

Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.

FOLFIRINOX:

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated

Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks

Chemoradiation:

Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.

Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated

1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15

125 mg/m2 IV over 30 minutes, day 1, 8, 15

Abraxane

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated

FOLFIRINOX

Chemoradiation

Peter O'Dwyer, MD

Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.

Abramson Cancer Center at Penn Medicine

FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated

Chemoradiation

Arm 1

Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15

Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15

Chemoradiation

Arm 2

Total

Age, Categorical

Jennifer Louie, Program Manager

Number of Participants With Relapse-free Survival

Gemcitabine/Abraxane

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:

12 Gy x 3 fractions (36 Gy total)

Stereotactic Body Radiation Therapy (SBRT)

David A Clump, MD

The current study seeks to further investigate the impact of Stereotactic Body Radiation Therapy following pancreatic resection with a close or positive margin. The investigators hope to improve local control, and through the use of a shortened treatment schedule, allow patients to begin systemic therapy earlier.

Radiation simulation will be done in Shadyside Radiation Oncology department Contrast-enhanced CT based simulation will be obtained prior to any adjuvant treatment (2-4 weeks post-op depending on healing). The target volume will be identified based on fiducial marker placement at time of surgery as well as a detailed discussion and image review with the operating surgeon. This are will be contoured on axial CT images obtained at 1.25 mm slice thickness. These volumes will then be reconstructed into a 3-dimensional image set for SBRT planning. Subjects will be simulated in the treatment position (supine with arms raised) on the CT scanner table the appropriate immobilization. Optiray® contrast will be administered intravenously at a flow rate of 2.5 mL/s. A helical CT scan of the abdomen will be acquired with intravenous contrast starting 30 seconds prior to CT acquisition.

A 4D CT data acquisition for the same axial extent will be obtained. The images will then be electronically transferred from the CT workstation via DICOM3 to the appropriate treatment planning workstation in the department of radiation oncology. Based on axial CT images, fiducial marker placement, review of the pathology report, and a detailed discussion with the operating surgeon, contours will be drawn of the clinical target volume (CTV), which is defined as the area at risk for microscopic disease. The planning target volume (PTV) will be equivalent to the CTV unless motion is detected on the 4D motion study. If there is motion, the amount of motion in the superior-inferior, lateral, and anterior-posterior directions will be the margin given. Surrounding normal and critical structures will also be contoured by the treating radiation oncologist including the kidneys, liver, small bowel, spinal cord, and stomach if necessary.

Stereotactic Body Radiotherapy Planning An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV.

Careful evaluation of each plan will be conducted by the radiosurgical team to ensure that normal tissues and critical structures tolerances are maintained.

The maximum dose (in Gy) within the treatment volume (MD), prescriptions dose (PD), and the ratio of MD/PD (as a measure of heterogeneity within the target volume), prescription isodose volume (PIV in mm3), tumor volume (TV in mm3), and the ratio of PIV/TV (as a measure of dose conformity of the treatment relative to the target) will be recorded.

Evaluation during treatment The subjects will be carefully followed while on active treatment and post-treatment for 24 months, or until death.

Treatment following SBRT All patients will have been seen in a multi-disciplinary pancreatic cancer clinic. As such, they will be set up with a medical oncologist. Following completion of SBRT as described in this protocol, the patient's medical oncologist may, at his/her discretion, administer systemic therapy according to the current standard of care or the UPMC pathways.

SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma

SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma A Prospective Evaluation in Select Patients With Resected Pancreas Cancer

Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

Percentage of patients without disease progression in target lesion from time from enrollment until one month. Death or development of distant disease is not regarded as an event. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

Time duration that patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

Percentage of patients that did not experience distant metastasis. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

Percentage of patients without distant disease metastasis (progression of disease beyond local target lesion).

Percentage of patients that experienced acute toxicity (defined as toxicity occurring within 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.

Percentage of patients that experienced late toxicity (defined as toxicity occurring after 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.

Percentage of patients that did not experience disease progression at 2 years. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

The time from enrollment to disease progression. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

The length of time from enrollment to confirmed death from any cause.

Percentage of patients alive at 1-year (death from any cause).

Percentage of patients alive at 2-years (death from any cause).

The FACT-G is a 27 item questionnaire that assesses physical, social/family, emotional, and functional well-being, provided to patients and self-administered prior to SBRT, after completion of SBRT, and at each follow-up. The survey takes 5 minutes to complete and employs as five-point scale from 0 (not at all) to 4 (very much). Subscale scores added to obtain total score. Scoring range is between 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better QoL.

David A. Clump, MD, PhD

Assistant Professor, Radiation Oncology

Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:

12 Gy x 3 fractions (36 Gy total)

Stereotactic Body Radiotherapy

Age, Continuous

Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS

Patients that received study treatment per protocol and were evaluable for response.

Local Progression-free Survival (LPFS) at 1-year

Local Progression-free Survival (LPFS) at 2-years

Local Progression-free Survival (LPFS)

Regional Progression-free Survival (RPFS)

Regional Progression-free Survival (RPFS) at 2-years

Distant Metastasis-free Survival (DMFS) at 2 Years

Distant Metastasis-free Survival (DMFS)

Patients that received study treatment per protocol and experienced acute grade 3 þ radiation toxicity.

Acute Toxicities Associated With SBRT

Late Toxicities Associated With SBRT

2-year Progression-free Survival (PFS)

Time to Progression (TTP)

Overall Survival (OS)

Overall Survival (OS) at 1-year

Overall Survival (OS) at 2-years

Physical well-being (PWB) - Before treatment (baseline)

Physical well-being (PWB) - Shortly after neo-adjuvant treatment

Physical well-being (PWB) - Shortly after surgery

Physical well-being (PWB) - Shortly after SBRT

Physical well-being (PWB) - Shortly after adjuvant treatment

Social/family well-being (SWB) - Before treatment (baseline)

Social/family well-being (SWB) - Shortly after neo-adjuvant treatment

Social/family well-being (SWB) - Shortly after surgery

Social/family well-being (SWB) - Shortly after SBRT

Social/family well-being (SWB) - Shortly after adjuvant treatment

Emotional well-being (EWB) - Before treatment (baseline)

Emotional well-being (EWB) - Shortly after neo-adjuvant

Emotional well-being (EWB) -Shortly after surgery

Emotional well-being (EWB) -Shortly after SBRT

Emotional well-being (EWB) - Shortly after adjuvant treatment

Functional well-being (FWB) - Before treatment (baseline)

Functional well-being (FWB) - Shortly after neo-adjuvant

Functional well-being -Shortly after surgery

Functional well-being (FWB) Shortly after SBRT

Functional well-being (FWB) Shortly after adjuvant treatment

Total score - Before treatment (baseline)

Total score - Shortly after neo-adjuvant

Total score - Shortly after surgery

Total score - Shortly after SBRT

Total score - Shortly after adjuvant treatment

Patients that completed FACT-G Quality of Life surveys.

Quality of Life (QoL) FACT-G

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Poly I-C

Poly ICLC

Interferons

Immunologic Factors

Antiviral Agents

MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description

MAGE-A3 ASCI injections without Poly IC:LC

MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description

MAGE-A3 ASCI injections with Poly IC:LC

Nikhil Khushalani, M.D.

The overall purpose of this research study is to find a better way to treat melanoma.

The goals of this study are:

1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC
2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with or without the Poly IC:LC
3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC
4. To measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC.

In the first year, participants may receive up to 8 injections given in the following order:

1. 5 ASCI injections with or without Poly IC:LC with a 3-week interval between each.
2. 3 ASCI injections with or without Poly IC:LC with a 3-month interval between each.

   During years 2 through 3, participants may receive up to 5 ASCI injections with or without Poly IC:LC given in the following order:
3. During year 2, ASCI injections with or without Poly IC:LC will be given every 3 months for a total of up to 3 injections.
4. During year 3, ASCI injections with or without Poly IC:LC will continue to be given every 3 months for a total of up to 2 more injections.

Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC

A Randomized Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC in Patients With Resected MAGE-A3 Positive, Stage IV Melanoma

Immunogenicity as measured by T cell responses directed against MAGE-A3 antigen.

A potential correlation between gene expression profile and treatment clinical activity (RFS) in both study arms (recMAGE-A3 + AS15 ASCI and recMAGE-A3 + AS15 ASCI in combination with Poly IC:LC).

Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC

Laboratory Endpoint: Assessment of the immunogenicity of the two regimens. Serum antibodies (such as Anti-MAGE-A3) seropositivity status (a seropositive patient is a patient whose titre is greater than or equal to the cut-off value) will be the primary immune endpoints assessed. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2).

RFS, defined as the time from randomization to the date of first relapse of melanoma or of death, whichever comes first. Percentage of participants with RFS, assessed up to 2 years is reported

OS defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last assessment. The primary analysis will be based on the adjusted Cox regression model.

GlaxoSmithKline

Oncovir, Inc.

H. Lee Moffitt Cancer Center and Research Institute

ASCI injections without Poly IC:LC

MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description

A: recMAGE-A3 + AS15

ASCI injections with Poly IC:LC

MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description

B: recMAGE-A3 + AS15 + Poly IC:LC

Race White / Ethnicity Non-Hispanic

Race/Ethnicity, Customized

All participants enrolled on study. All participants who received study treatment. Outcome Measures: All participants evaluable at time of analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck	NCT03057613	Squamous Cell C...	Pembrolizumab IMRT 60-66Gy	18 Years -	Case Comprehensive Cancer Center
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma	NCT01839799	Pancreatic Aden...	Gemcitabine Abraxane FOLFIRINOX Chemoradiation	18 Years -	Abramson Cancer Center at Penn Medicine
SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma	NCT01357525	Adenocarcinoma ...	Stereotactic Bo...	18 Years - 99 Years	University of Pittsburgh
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC	NCT01437605	Melanoma	MAGE-A3 ASCI in... MAGE-A3 ASCI in...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma	NCT01357525	Adenocarcinoma ...	Stereotactic Bo...	18 Years - 99 Years	University of Pittsburgh
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC	NCT01437605	Melanoma	MAGE-A3 ASCI in... MAGE-A3 ASCI in...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation	NCT01746251	Non Small Cell ...	Afatinib	18 Years -	Massachusetts General Hospital
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma	NCT01839799	Pancreatic Aden...	Gemcitabine Abraxane FOLFIRINOX Chemoradiation	18 Years -	Abramson Cancer Center at Penn Medicine
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)	NCT01964430	Pancreatic Neop... Digestive Syste... Neoplasms by Si... Neoplasms Endocrine Gland... Pancreatic Dise... Digestive Syste... Endocrine Syste... Gemcitabine Antimetabolites...	nab-Paclitaxel Gemcitabine	18 Years -	Celgene
Microbiome Immunotherapy Toxicity and Response Evaluation	NCT04107168	Melanoma Renal Cancer Lung Cancer	Nivolumab Pembrolizumab Ipilimumab Durvalumab Tremelimumab Atezolizumab Bevacizumab	18 Years -	Cambridge University Hospitals NHS Foundation Trust

Spots Global Cancer Trial Database for resected

Every month we try and update this database with for resected cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for resected

Every month we try and update this database with for resected cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for resected cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.