Epacadostat for Cancer of Pancreas

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Cancer of Pancreas+1 More
Epacadostat - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Adenocarcinoma Metastatic

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Epacadostat will improve 2 primary outcomes and 17 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of 1 year.

1 year
Recommended Dose of Epacadostat
4 years
6 Month Survival
Best Overall Response (BOR)
Disease Control Rate (DCR)
Duration of Clinical Benefit (DCB)
Duration of Response (DOR)
Number of patients experiencing treatment related toxicities
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
Time to Objective Response (TTOR)
Tumor Marker (CA19-9) Kinetics
immune-related Best Overall Response (irBOR)
immune-related Disease Control Rate (irDCR)
immune-related Duration of Clinical Benefit (irDCB)
immune-related Duration of Response (irDOR)
immune-related Objective Response Rate (irORR)
immune-related Progression Free Survival (irPFS)
immune-related Time to Objective Response (irTTOR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Epacadostat/Pembrolizumab/CRS-207
1 of 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
1 of 2
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Epacadostat is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Epacadostat/Pembrolizumab/CRS-207
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GVAX
2015
Completed Phase 2
~200
Epacadostat
Not yet FDA approved
CRS-207
2015
Completed Phase 2
~490
Cyclophosphamide
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Closest Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient is expected to live for more than three months. show original
The study looked at the organ and marrow function of participants and defined it by specified laboratory tests. show original
Documented adenocarcinoma of the pancreas
Patients who have progressed after prior chemotherapy for metastatic pancreatic cancer, either adjuvant or neoadjuvant if progression occurred within 6 months of completing that regimen, are candidates for gemcitabine and nab-paclitaxel. show original
on MRI The presence of at least one measurable lesion on MRI means that the person has a medical condition. show original
Patients were asked if they would be willing to have a tumor biopsy at 2 different time points show original
The patient has a good performance status. show original

Patient Q&A Section

What are common treatments for cancer of pancreas?

"There is some evidence that cancer of pancreas can be treated with surgery; some that it can be treated with chemotherapy; some that it can be treated with surgery + chemotherapy; and some that it is impossible to diagnose." - Anonymous Online Contributor

Unverified Answer

What causes cancer of pancreas?

"Pancreas cancer occurs more commonly in male than female individuals. It has been suggested that a combination of various environmental, genetic and physiological factors may be involved in triggering cancer. A strong association between pancreatic cancer and smoking is observed, and several candidate genes have been identified." - Anonymous Online Contributor

Unverified Answer

Can cancer of pancreas be cured?

"With curative intent, a tumor with malignant potential will almost never be totally eradicated, even if the tumor is removed by curettage and/or surgery. However, with early diagnosis and treatment of pancreatic cancer-related complications, survival can be excellent and is comparable to patients who are diagnosed later during the disease course." - Anonymous Online Contributor

Unverified Answer

What is cancer of pancreas?

"Cancer of pancreas has a very high mortality as compared with general cancer rates. One of the reasons for such a high mortality is the frequent association of it with cancer of other organs. More than two thirds of pancreatic cancer cases are associated with a primary cancer (e.g., colorectal, prostate, stomach cancer). In the United States of America, there are around 4050 cases of pancreas diagnosed with cancer in every 100,000 annually. At the end of the 20th century, there were an estimated 2480 to 2804 new cases of pancreatic cancer in every 100 000 population of people each year. Over the last 100 years, the rate of incidence for the United States increased around 20-fold." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer of pancreas?

"Symptoms of pancreatic cancer such as weight loss, abdominal pain and jaundice may be early abnormalities that could be caused by both adenocarcinoma of pancreas and neuroendocrine tumour." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of pancreas a year in the United States?

"About 434,800 people i the United States die from pancreas cancer each year. Which means that about one life of every nine in the United States is taken by someone i a year.\n" - Anonymous Online Contributor

Unverified Answer

Does epacadostat improve quality of life for those with cancer of pancreas?

"In this small analysis, higher doses of epacadostat led to modest improvements in quality of life for patients with cancer of pancreas. This could have implications for combination therapy with epacadostat. Further studies are required to determine any meaningful benefit for patients with these advanced cancers." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer of pancreas?

"Cancer of pancreas is a very common disease and is difficult to diagnose early. The use of targeted therapies in combination with immunotherapy has been proven in the metastasis of pancreatic adenocarcinoma and in pancreatic ductal adenocarcinoma, but its effectiveness in adjuvant metastatic [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) merits a further investigation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer of pancreas?

"Although the number of respondents was small, and the number of respondents from the US and Japan was lower than that from Australia and Scandinavia, this study suggests that clinicians should play a pivotal role in making decisions regarding clinical trials for cancer of the pancreas." - Anonymous Online Contributor

Unverified Answer

Does cancer of pancreas run in families?

"Cancer of pancreas runs in families. The fact that there were three affected siblings in the families indicates a possible genetic contribution to the disease. Future studies using linkage analysis to identify genetic risk factors for cancer of pancreas are warranted in order to help in the development of early diagnosis and better management." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer of pancreas?

"[A large number of agents were found to display antineoplastic properties against different types of cancers. (...) The use of many new antineoplastic substances with a different pharmacokinetic properties was recommended for future study, as well as clinical trials in order to determine its antineoplastic efficacy in specific tumor types or tumors, or whether it has a general effect on the survival time of patients. (...) A number of more potent agents are being used for the treatment of pancreatic cancer, such as fluoropyrimidines, etoposide, etoposide/5-fluorouracil, and gemcitabine. (..." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving epacadostat?

"The treatment was well tolerated. No significant difference was seen in progression-free survival between this study and the prior phase III study, underscoring the need for further exploration of the EZB4 targeting drug program in patients with EZH2(+) MDS." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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