Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Gastrointestinal Agents

Antibodies

Cyclophosphamide

Vaccines

Immunomodulating Agents

Nivolumab

Immunoglobulins

Pancrelipase

Pancreatin

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.

Patients receive low-dose cyclophosphamide and nivolumab IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide and nivolumab IV on day 0 and the vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide and nivolumab IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide, nivolumab, and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive nivolumab every 4 weeks for another 6 treatments as well as cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.

Patients receive low-dose cyclophosphamide, nivolumab, and urelumab on day 0 and GVAX pancreatic cancer vaccine on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide, nivolumab, and urelumab on day 0 and the vaccine on day 1. Beginning approximately 28 days after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide, nivolumab, and urelumab on day 0 and GVAX on day 1. Treatment with cyclophosphamide, nivolumab, urelumab, and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive nivolumab and urelumab every 4 weeks for another 6 treatments as well as cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.

Patients receive BMS-986253 and nivolumab on day 0 (Cycle 1), 15 days prior to surgery. 6-10 weeks after surgery, patients receive Cycle 2, with nivolumab on day 0 and BMS-986253 on days 0 and 14. Patients then receive standard adjuvant chemoradiotherapy. Approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive 4 additional 28-day cycles of immunotherapy, with Nivolumab on Day 0 and BMS-986253 on Days 0 and 14. Patients will then enter the extended treatment phase where they will receive nivolumab alone every 4 weeks for another 6 treatments.

GVAX pancreatic cancer

Urelumab

BMS-986253

Carol Judkins, RN

Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce

Lei Zheng, MD, PhD

This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.

Immunotherapy is an innovative approach being developed for the treatment of pancreatic cancer, a lethal and relatively chemotherapy-resistant disease. However, the tumor and its environment have developed a number of ways in which they inhibit the function of the immune system preventing it from recognizing and killing the cancer. In addition, the investigators still do not understand how T cells, the cells in the immune system that have the potential to recognize cancer as different and kill cancer cells, traffic into the tumor to accomplish their task. The investigators are currently testing an immune system activating pancreatic cancer vaccine (known as GVAX) in combination with immune boosting doses of the chemotherapy agent, cyclophosphamide, as preoperative and postoperative treatments for pancreatic cancer. The investigators have discovered tertiary lymphoid aggregates, a unique lymph node-like structure formed within resected tumors from the patients who received the vaccine two weeks prior to the surgery. This discovery demonstrates that the immune system can get into the tumor and provides the investigators with the opportunity to better understand how these immune cells traffic into the tumor and function once they arrive. The investigators also found that the vaccine causes an increase in signals that would suppress the immune system's ability to fight off cancer cells, including signals involving PD-1. In this novel study, the investigators will test the effects of blocking PD-1 in combination with the vaccine in patients with pancreatic cancer. The investigators will specifically isolate these immune cells and evaluate at both the genetic and protein level, the types of signals expressed by these aggregates. The investigators will compare aggregates from patients with long term survival versus patients who succumb to their cancer early. In this way, the investigators will be able to determine how safe this novel treatment is, how effective it is at changing the immune system in pancreatic cancer, and how it impacts the health and survival of pancreatic cancer patients who undergo surgery to remove the cancer.

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

A Platform Study of Combination Immunotherapy for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas

median IL17A expression in lymphoid aggregates from resected tumor (Arms A and B only)

Fold change of intratumoral CD8+CD137+cells before and after neoadjuvant therapy (Arms B and C only)

Percent change of intratumoral granzyme B+PD-1+CD137+ cells in surgical (post-treatment) tissue compared to baseline (pre-treatment) biopsy (Arm D only)

Percent of patients with a response grade of 0-2 (0=complete response 1=marked response, 2=moderate response) at time of surgery

Number of participants experiencing study drug-related toxicities

Overall Survival is defined as the time from surgery to death from any cause

Disease Free Survival is defined as the time from surgery until evidence of disease recurrence or death from any cause

National Cancer Institute (NCI)

Bristol-Myers Squibb

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, B-Cell

Lymphosarcoma

B-cell Lymphoma

Rituximab

Urelumab (BMS-663513) flat dose intravenous infusion on specified days

Rituximab intravenous flat dose infusion on specified days

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma

Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design

Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma

A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies

The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.

Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors

28 days/cycle for combination therapy of Urelumab and Nivolumab

Ono Pharmaceutical Co. Ltd

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Nivolumab followed by Urelumab

Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles

The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma

The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.

Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.

DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first.

Data was not collected due to discontinuation of the study/Due to study termination.

PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time.

Data was not collected due to discontinuation of the study/Due to study termination.

Data was not collected due to discontinuation of the study/Due to study termination.

TRT A

TRT B

TRT D

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

The Incidence of Adverse Events.

The Incidence of Seriuos Adverse Events.

The Incidence of Death.

Complete response

Partial response

URE8 Q4WK+NIV240mg Q2WK- Non small cell lung cancer pd1/pd-l1 experienced

TRT D - NSCLC pd1/Pd-l1 Experienced

URE8 Q4WK+NIV240mg Q2WK - Non samll cell lung cancer pd1/pd-l1 naive.

TRT D - NSCLC pd1/Pd-l1 Naive

URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 experienced

TRT D - Melanoma pd1/Pd-l1 Experienced

URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive

TRT A - Melanoma pd1/Pd-l1 Naive

URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive

TRT B -

URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive

TRT D - Melanoma pd1/Pd-l1 Naive

URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.

TRT A - SCCHN

URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.

TRT D - SCCHN

TRT A - Other Solid Tumors

URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.

TRT B - Other Solid Tumors

URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.

TRT D - DLBCL

URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.

TRT D - FL

Best Overall Response (BOR)

Objective Response Rate (ORR)

Baseline ADA positive

ADA positive

ADA negative

Urelumab ADA

Nivolumab ADA

Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab

Duration of Response (DOR)

Progression-free Survival Rate (PFSR)

Maximum Observed Serum Concentration (Cmax)

Time of Maximum Observed Serum Concentration (Tmax)

Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)

Trough Observed Plasma Concentration(Ctrough)

End of Infusion Concentration (Ceoinf)

Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Patients will receive stereotactic body radiation therapy (SBRT) in combination with nivolumab and urelumab.

Patients will receive stereotactic body radiation therapy (SBRT) in combination with nivolumab and cabiralizumab .

Nivolumab 240 mg given by intravenous infusion every 2 weeks

Cabiralizumab 4 mg/kg given by intravenous infusion every 2 weeks

Cabiralizumab

Urelumab 8 mg given by intravenous infusion every 4 weeks

Radiation to metastatic lesion(s) given at assigned dose levels based on lesion location and dose level being tested at time of enrollment. Doses range from 30 - 50 Gy.

Stereotactic Body Radiation Therapy

Jason Luke, MD

Study to determine the best dose of stereotactic body radiation therapy (SBRT) to be administered in combination with immunotherapy drugs including urelumab, cabiralizumab and nivolumab .

Patients will be enrolled in parallel based on physician preference and slot availability.

Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer

Platform Phase 1 Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Immuno-oncology Agents for the Treatment of Multiple Metastases in Advanced Solid Tumors

Dose of stereotactic body radiation therapy (SBRT) that can safety be given with immunotherapy.

Rate of side effects seen in study participants.

Rate of long term (occurring 6 month or more after treatment) side effects seen in study participants.

Number of participants that do not have disease worsening.

Rate of disease control (tumor shrinkage) of radiation treated lesions.

University of Chicago

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Cetuximab

Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.

Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer

A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck

As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas	NCT02451982	Pancreatic Canc...	Cyclophosphamid... GVAX pancreatic... Nivolumab Urelumab BMS-986253	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma	NCT01775631	B-Cell Malignan...	Urelumab Rituximab	18 Years -	Bristol-Myers Squibb
Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors	NCT02534506	Malignant Tumor...	Urelumab Nivolumab	20 Years -	Bristol-Myers Squibb
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma	NCT02253992	Advanced Solid ... Advanced B-cell...	Urelumab Nivolumab	18 Years -	Bristol-Myers Squibb
Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer	NCT03431948	Cancer	Nivolumab Cabiralizumab Urelumab Stereotactic Bo...	18 Years -	University of Chicago
Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer	NCT02110082	Colorectal Canc... Head and Neck C...	Urelumab Cetuximab	18 Years -	Bristol-Myers Squibb
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma	NCT02253992	Advanced Solid ... Advanced B-cell...	Urelumab Nivolumab	18 Years -	Bristol-Myers Squibb
Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors	NCT02534506	Malignant Tumor...	Urelumab Nivolumab	20 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for urelumab

Every month we try and update this database with for urelumab 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 urelumab

Every month we try and update this database with for urelumab 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 urelumab 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.