Niraparib + Dostarlimab + RT in Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04409002|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : October 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Metastatic Pancreatic Cancer||Drug: Niraparib Drug: Dostarlimab Radiation: Radiation||Phase 2|
This two-stage single arm phase II trial will evaluate the efficacy of niraparib with dostarlimab and radiation therapy in patients with metastatic pancreatic cancer
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
The names of the experimental interventions involved in this study are:
- Radiation Therapy
It is expected that about 25 people will take part in this research study. An initial 15 participants will be enrolled during the first stage and evaluated for treatment disease control, if none of the initial 15 participants achieve disease control the study will be terminated.
It is expected participants will be on the research study for as long as the experimental interventions are safe, and their metastatic pancreatic cancer does not progress with up to 5 years of follow up after participants stop taking the experimental interventions.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The U.S. Food and Drug Administration (FDA) has not approved dostarlimab as a treatment for any disease. Dostarlimab is a type of antibody (a protein that attaches to other cells to fight off infection) that is believed to work by attaching to a protein called PD-1 on Tcells.
This PD-1 protein controls parts of the immune system (the system in the body that fights off infections and diseases) by shutting down certain immune responses responsible for recognizing and destroying cancer cells. The investigators believe that dostarlimab will inhibit the PD-1 protein, thus allowing the immune cells to recognize and destroy cancer cells. The FDA has not approved niraparib for metastatic pancreatic cancer, but it has been approved for other uses. Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring. It is believed that the combination of dostarlimab, niraparib, and radiation therapy may have a greater effect on metastatic pancreatic cancer cells than when these interventions are used alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Niraparib and Dostarlimab With Radiation in Patients With Metastatic Pancreatic Cancer|
|Actual Study Start Date :||July 23, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||October 1, 2026|
Experimental: Niraparib+Dostarlimab + Radiation
Each study treatment cycle lasts 21 days
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Other Name: Zejula
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
- Disease control rate with RECIST 1.1 [ Time Frame: 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.
- Disease control rate with rRECIST [ Time Frame: 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.
- Progression-free survival [ Time Frame: 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.
- Overall survival [ Time Frame: 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.
- Number of Participants With Treatment-Related Adverse Events CTCAE.v 5.0 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409002
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Theodore S Hong, MD||Massachusetts General Hospital|