Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

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

14-O-phosphonooxymethyltriptolide disodium salt

Antineoplastic Agents, Alkylating

Alkylating Agents

0.67 mg/m2 Minnelide daily as a 30min iv infusion on days 1-21 of each 28 day cycle, followed by a 7 day rest period (D 22-28).

Minnelide will be administered at the dose of 0.67 mg/m2 as a 30 min infusion intravenously daily on days 1-21 of each cycle followed by a 7 day rest period (days 22-28).

Minnelide

David Propper

Erkut Borazanci

MinPAC aims to see if the drug Minnelide can slow down tumour growth in patients with pancreatic cancer that is not responding to treatment. Minnelide is designed to rapidly release the anti-tumour molecule triptolide in the bloodstream and has been shown to slow cancer cell growth and induce cancer cell death. Minnelide is currently being investigated in other early phase trials and has shown promising response data.

There are strict eligibility criteria for this trial. Broadly speaking, patients with pancreatic cancer that has spread to other organs and has progressed on one or more chemotherapy regimens are eligible. Participants will receive Minnelide on days 1-21 of each 28 day cycle until their cancer stops responding to treatment. After that participants will be followed up 3 monthly for the collection of disease status and survival data.

MinPAC includes biological and imaging studies. Participants will be asked to donate tumour and blood samples and will be asked to undergo additional PET Scans. The study is being carried out in 4 sites in the UK and USA.

MinPAC is an open label, international, multicentre phase II trial that aims to evaluate the effects of Minnelide treatment in patients with refractory pancreatic cancer. Eligible patients will receive Minnelide until disease progression unless there is evidence of unacceptable toxicity or the patient requests to be withdrawn from the study treatment. Once disease progression is documented, patients will enter a follow up phase during which data will be collected on further disease and survival status. If patients are unable to attend hospital visits during the follow up period then data will be collected either via telephone or via national registries with the patient's consent. The efficacy of Minnelide will be assessed on CT/MRI scan images and tumour and/or blood samples collected at baseline, during treatment and on completion of treatment.

A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer

MinPAC: A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer.

Changes in circulating tumour stem cells.

Time from enrolment until disease progression or death from any cause, whichever occurs first (RECIST v1.1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer	NCT03086642	Pancreatic Canc...	Talimogene lahe...	18 Years -	Columbia University
A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer	NCT03117920	Pancreatic Canc...	Minnelide	18 Years -	Minneamrita Therapeutics LLC
Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer	NCT03086642	Pancreatic Canc...	Talimogene lahe...	18 Years -	Columbia University
A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer	NCT03117920	Pancreatic Canc...	Minnelide	18 Years -	Minneamrita Therapeutics LLC

Spots Global Cancer Trial Database for refractory pancreatic cancer