Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Pancreatic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pancreatic Cancer

* Patients will have blood and tumor collected at various time points throughout participation in the study.
* Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.

Cliff Robinson, M.D.

Carl DeSelm, M.D., Ph.D.

Stephanie Markovina, M.D., Ph.D.

Julie Schwarz, M.D., Ph.D.

Jessika Contreras, M.D.

Dineo Khabele, M.D.

David DeNardo, Ph.D.

Hyun Kim, M.D.

Kian-Huat Lim, M.D.

Ryan Fields, M.D.

Jeff Szymanski, M.D.

Hua Li, Ph.D.

Albert Lai, Ph.D.

Philip Payne, Ph.D.

Doug Caruthers, M.S.

Esther Lu, Ph.D.

Lei Liu, Ph.D.

Andrea Hagemann, M.D.

Lindsay Kuroki, M.D.

Leslie Stuart Massad, M.D.

Carolyn McCourt, M.D.

Maggie Mullen, M.D.

Matthew Powell, M.D.

Brooke Sanders, M.D.

Premal Thaker, M.D.

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment (imaging, dosimetry, clinical) data before, during, and after treatment with definitive-intent standard of care (SOC) radiotherapy for patients with locally advanced cervical and pancreatic cancer.

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)

Data will be presented at scientific meetings \& published in journals. Individual-level \& aggregate genomic data will be deposited/made available through GEO \& SRA. Includes sequence, transcriptomic, epigenomic, \& gene expression data. Raw mass spectra \& unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE \& ProteomeEXchange to share protein identifications \& spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH \& institutional regulations. BLST will manage \& assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.

Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.

National Cancer Institute (NCI)

Washington University School of Medicine

Gastrointestinal Agents

All Drugs and Chemicals

Antineoplastic Agents

Pancrelipase

Pancreatin

Talimogene laherparepvec

Antineoplastic Agents, Immunological

All enrolled patients will receive a test dose of talimogene laherparepvec (10\^6 plaque forming units (PFU)/ml) on day 1, followed by treatment doses at escalating concentrations weeks 4, 7, and 10. A biopsy will be obtained during each scheduled endoscopy prior to talimogene laherparepvec injection.

T-Vec will be administered by intratumoral injection into pancreatic tumors accessible endoscopically with ultrasound guidance (at least one pancreatic lesion must be injected during each treatment).

On day 1 of week 1 the first dose of talimogene laherparepvec will be up to 4.0 mL of 10\^6 PFU/mL. The second injection up to 4.0 mL of 10\^6, 10\^7, or 10\^8 PFU/mL should be administered no sooner than day 1 of week 4 but should not be delayed more than 7 days after the scheduled time point. The maximum volume of T-Vec administered at any one time is 4.0 mL for any individual lesion.

Karie Runcie, MD

The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth.

The primary objective is to determine the rate of dose limiting toxicity at tested doses of talimogene laherparepvec administered endoscopically to pancreatic tumors, and to identify a maximum tolerated dose (MTD).

Secondary exploratory efficacy endpoints include change in longest diameter in the injected lesion(s), overall response rate (ORR) per RECIST v1.1 and modified immune-related response criteria (mirRC as defined in section 11), progression free survival (PFS) and overall survival (OS) at 6, 12, and 24 months.

Funding Source - FDA OOPD

Pancreatic ductal adenocarcinoma (PDA) is an area of great unmet need. PDA accounts for 90% of pancreatic tumors in 2016. The standard of care for pancreas cancer is cytotoxic chemotherapy, but this is not particularly effective with best response rates reported of 20-30% and no significant long-term 5-year survival for patients who are not surgical candidates. Talimogene laherparepvec (previously known as OncoVEXGM-CSF) is an intratumorally delivered oncolytic immunotherapy comprised of an immune-enhanced herpes simplex virus type-1 (HSV-1) that selectively replicates in solid tumors. Talimogene laherparepvec was the first oncolytic viral therapy to be approved by the Federal Drug Administration (FDA) for the treatment of cancer, specifically melanoma. There is the potential that talimogene laherparepvec could exert a systemic effect mitigating the potential of PDA to metastasize.

This is a phase 1 dose escalation study to evaluate the safety of talimogene laherparepvec in PDA. To find out which doses are safe, all participants enrolled in this study will receive up to 4 injections of T-Vec. At least two doses will be evaluated in this study, depending on how many side effects are seen at each dose. Participants will not be able to pick the dose, as this will be determined based on the study experience with participants enrolled previously.

Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer

Study of Talimogene Laherparepvec Administered Endoscopically for the Treatment of Locally Advanced or Metastatic Pancreas Cancer Refractory to at Least One Chemotherapy Regimen

To determine the highest dose of study treatment that does not cause unacceptable side effects.

To make an exploratory assessment of activity of talimogene laherparepvec in pancreatic cancer, as measured by change in size of the injected lesion(s)

The percentage of patients whose cancer shrinks or disappears after treatment.

The length of time during and after the study treatment of cancer, that a patient lives with the disease but it does not get worse.

The length of time from either the date of diagnosis or the start of study treatment for cancer, that patients diagnosed with the disease are still alive.

Amgen

Karie D. Runcie, MD

Assistant Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial	NCT05975593	Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Cervical Cancer Pancreas Cancer Pancreatic Canc... Cancer of the C... Cancer of the P...		18 Years -	Washington University School of Medicine
Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer	NCT03086642	Pancreatic Canc...	Talimogene lahe...	18 Years -	Columbia University
Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer	NCT03086642	Pancreatic Canc...	Talimogene lahe...	18 Years -	Columbia University
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial	NCT05975593	Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Cervical Cancer Pancreas Cancer Pancreatic Canc... Cancer of the C... Cancer of the P...		18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for locally advanced pancreas cancer