CLINICAL TRIAL

Dostarlimab for Cancer of Pancreas

Metastatic
Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether a combination of drugs and radiation therapy may help treat pancreatic cancer.

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About the trial for Cancer of Pancreas

Eligible Conditions
Malignant Neoplasm of Pancreas · Pancreatic Neoplasms · Pancreatic Metastatic Cancer

Treatment Groups

This trial involves 2 different treatments. Dostarlimab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Radiation
RADIATION
Niraparib
DRUG
Dostarlimab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2005
Completed Phase 3
~990
Niraparib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Creatinine levels must be less than 1.5 times the upper limit of the normal range, or creatinine clearance must be at least 60 milliliters per minute using the Cockcroft-Gault formula. show original
leukocytes ≥ 2,000/mcL
A person has an absolute neutrophil count of at least 1,500/mcL if their neutrophil count is 1,500 or higher per cubic millimeter. show original
Platelets that are 100,000 or more per milliliter are considered high. show original
hemoglobin ≥ 9 g/dL
and an ALT (SGPT) ≤3 x ULN) If the AST(SGOT) and ALT(SGPT) levels are ≤2.5 times the institutional upper limit of normal, the individual has liver metastases show original
This is a medical diagnosis for cancer that has spread from the pancreas to other parts of the body. show original
Age > 18 years.
The patient has a very good performance status. show original
The patient is expected to live for more than three months. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: first dose of protocol treatment up to First followup/ off study visit up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: first dose of protocol treatment up to First followup/ off study visit up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: first dose of protocol treatment up to First followup/ off study visit up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dostarlimab will improve 1 primary outcome and 4 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of first day of protocol treatment to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive up to 5 years.

Overall survival
FIRST DAY OF PROTOCOL TREATMENT TO THE DATE OF DEATH DUE TO ANY CAUSE AND WILL BE CENSORED AT THE DATE OF LAST FOLLOW-UP FOR PATIENTS STILL ALIVE UP TO 5 YEARS
Overall survival is defined as the duration from the The OS rate will be estimated by the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
FIRST DAY OF PROTOCOL TREATMENT TO THE DATE OF DEATH DUE TO ANY CAUSE AND WILL BE CENSORED AT THE DATE OF LAST FOLLOW-UP FOR PATIENTS STILL ALIVE UP TO 5 YEARS
Progression-free survival
FIRST DAY OF PROTOCOL TREATMENT TO THE EARLIER DATE OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE UP TO 5 YEARS
The PFS rate will be estimated by the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
FIRST DAY OF PROTOCOL TREATMENT TO THE EARLIER DATE OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE UP TO 5 YEARS
Disease control rate with rRECIST
3 MONTHS UP TO 2 YEARS
The rate of disease control evaluated by irRECIST will be estimated with the 95% confidence interval based on the exact binomial distribution.
3 MONTHS UP TO 2 YEARS
Disease control rate with RECIST 1.1
3 MONTHS UP TO 2 YEARS
The disease control rate will be reported as a summary measure of disease response evaluated by RECIST 1.1 and estimated with the 95% confidence interval based on the exact binomial distribution.
3 MONTHS UP TO 2 YEARS
Number of Participants With Treatment-Related Adverse Events CTCAE.v 5.0
FIRST DOSE OF PROTOCOL TREATMENT UP TO FIRST FOLLOWUP/ OFF STUDY VISIT UP TO 2 YEARS
Toxicity associated with the combination of niraparib and dostarlimab with radiation will be summarized by category and grade.
FIRST DOSE OF PROTOCOL TREATMENT UP TO FIRST FOLLOWUP/ OFF STUDY VISIT UP TO 2 YEARS

Who is running the study

Principal Investigator
T. S. H.
Theodore Sunki Hong, Principal Investigator
Massachusetts General Hospital

Patient Q & A Section

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

What is cancer of pancreas?

Cancer of pancreas is a disease of the pancreas, which is the uppermost (and largest) of the two lobes of the liver that make up the human digestive system. Pancreatic cancer is one of the most common types of cancer, accounting for nearly 10% of cancer in adults.\n

Anonymous Patient Answer

Can cancer of pancreas be cured?

We found no reliable evidence to support this viewpoint. Many investigators have failed to find benefit from clinical trials using different cancer drugs, in combination or as monotherapy.

Anonymous Patient Answer

What causes cancer of pancreas?

The high incidence of pancreatic cancer is mostly caused by increased age and smoking. The increasing prevalence of chronic hepatitis C virus infection may play a role.

Anonymous Patient Answer

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

Among men, it is estimated that every 44th person in the United States will develop pancreas cancer in his lifetime. The high incidence of pancreatic cancer among men may be due to the fact that most cigarette smokers in the United States are also former or current pancreatitis sufferers and this group is likely to have increased incidence of pancreatic cancer. It is suggested that cigarette smoking may thus be one of contributory or causal risk factors for pancreatic cancer.

Anonymous Patient Answer

What are the signs of cancer of pancreas?

Frequently, it is difficult to make a diagnosis of CPTC with standard diagnostic tests. However, the symptoms of CPTC are similar to other cancer types.

Anonymous Patient Answer

What are common treatments for cancer of pancreas?

The prevalence of this disease dramatically increased in recent decades, which may be associated with increase in smoking and obesity. The most common treatment for this disease is surgery. However, chemotherapy, radiation therapy and targeted therapy may achieve better response.

Anonymous Patient Answer

Does cancer of pancreas run in families?

No evidence of cancer of pancreas run in families. Data from a recent study of cancer of pancreas gene families in the families studied does not contradict with existing theories about the aetiopathogenetic mechanism of this tumor. There are only a limited number of reports in the literature, because of the small number of cases in the families studied and therefore, further studies are necessary to replicate that result.

Anonymous Patient Answer

How quickly does cancer of pancreas spread?

Patients with early-stage cancers showed a higher survival rate after adjusting for the disease-free survival of each site. This suggests metastatic spread of cancer can be curable with surgery, in fact, local excision in some cases. As late-stage cancers tended to develop distant metastases, it is difficult to attain a cure with chemotherapy alone. In this regard, the metastasis-related factors were a weak predictor for survival after adjusting for the disease-free survival of each site.

Anonymous Patient Answer

What are the latest developments in dostarlimab for therapeutic use?

Findings from a recent study provide the first evidence of dostarlimab's activity in the treatment of human cancer, notably in pancreatic cancer. Findings from a recent study support the development of further trials to validate our data through randomized controlled trials.

Anonymous Patient Answer

What is dostarlimab?

For those patients who have received a chemotherapy regimen that incorporates a taxane and platinum for a curative treatment to the neoplastic cell population of their pancreas, a second-line treatment with a monoclonal antibody, dostarlimab, has shown benefit for improving the duration of survival beyond and beyond that predicted by its use for initial salvage chemotherapy of patients who have primary disease progression after surgery of pancreatic cancer (PANCREAS trials). The use of these two anti-cancer therapies together for pancreatic cancer appears to represent an intriguing clinical innovation.

Anonymous Patient Answer

Who should consider clinical trials for cancer of pancreas?

The decision to participate in a clinical trial for pancreatic cancer will be based as much on the expected benefits of treatment as on risks. The presence of an aggressive disease process, high grade tumors or significant comorbidities may suggest a poor outcome. However, patients are not all alike and some patients would fare better with treatment than others. There is an urgent need for trials of new and exciting agents tailored to the needs of the patient.

Anonymous Patient Answer

What is the survival rate for cancer of pancreas?

It is found that the survival rate in the present country where there are a number of centers specializing in [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) (in our country) is about 12% which is much lower than the survival rate that was found in another country (in France) which has a large number of centers in this field. And the survival rate for cancer of the pancreas in both countries differs significantly. As we know there are about 100 pancreatic cancer cases per 100 000 people per year in France, in our country we do not receive much cancer of the pancreas cases in the community because of lack of awareness and also because of the lack of specialized centers for this disease.

Anonymous Patient Answer
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