Niraparib + Dostarlimab + RT in Pancreatic Cancer

NCT04409002 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-538
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to see how the combination of dostarlimab, niraparib, and radiation therapy works in controlling metastatic pancreatic cancer.

Conditions

Pancreatic Cancer; Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer; Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate With RECIST 1.1 Criteria

  Disease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below. * CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. * SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study. * Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.

  up to 17 months

Secondary Outcomes (4)

• Disease Control Rate With irRECIST Criteria

  up to 17 months

• Progression-free Survival

  up to 17 months

• Overall Survival

  up to 17 months

• Number of Treatment-Related Adverse Events Per CTCAE v5.0

  up to 19 weeks

Study Arms (1)

Niraparib+Dostarlimab + Radiation

EXPERIMENTAL

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 * 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

Drug: Niraparib; Drug: Dostarlimab; Radiation: Radiation

Interventions

Niraparib DRUG

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

Also known as: Zejula

Niraparib+Dostarlimab + Radiation

Dostarlimab DRUG

Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study

Niraparib+Dostarlimab + Radiation

Radiation RADIATION

Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1

Niraparib+Dostarlimab + Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic adenocarcinoma of pancreatic origin.
• Age \> 18 years.
• ECOG performance status ≤ 1.
• Life expectancy of greater than 3 months.
• Participants must have normal organ and marrow function as defined below:
• leukocytes ≥ 2,000/mcL
• absolute neutrophil count ≥ 1,500/mcL
• platelets ≥ 100,000/mcL
• hemoglobin ≥ 9 g/dL
• AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal(subjects with liver metastases can have an AST (SGOT) ≤ 5 x ULN
• creatinine ≤ 1.5 x ULN OR
• creatinine clearance\* ≥ 60 mL/min (if using the Cockcroft-Gault formula)
• total bilirubin ≤ 1.5 x ULN (subjects with Gilbert Syndrome can have a total bilirubin \< 3 x ULN)
• INR, PT, aPTT ≤ 1.5 x ULN (subjects receiving anticoagulant therapy must have PT or PTT within therapeutic range) \*Creatinine clearance should be calculated per the following: CrCl (mL/min) = (140 - age \[years\]) x weight \[kg\] x 1.23 (x 0.85 if female)/ Serum creatinine (micromol/L)
• Women of childbearing potential (WoCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to initiating protocol therapy.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded:
• Systemic anticancer or biological therapy including prior chemotherapy, immunotherapy, targeted small molecule therapy within 14 days prior to investigational agent, or those who have not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier. Participants with ≤ grade 2 neuropathy are an exception to these criteria and may qualify for the study. If the participant received major surgery, then they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Received investigational therapy ≥ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
• Major surgery ≤ 3 weeks prior to initiating protocol therapy and/or not recovered from any surgical effects.
• Received radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy.
• Received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy
• Received colony-stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior to initiating protocol therapy. Known history of Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment.
• Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Active, known or suspected autoimmune disease that has required systemic treatment within the past 2 years other than vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
• Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intraarticular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \> 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
• Known history of active TB (Bacillus Tuberculosis). Testing is not required for eligibility purposes.
• Known hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Testing is not required for eligibility purposes.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). These participants are at increased risk of lethal infections when treated with marrow suppressive therapy. Testing is not required for eligibility purposes.
• Known ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent (within 90 days) myocardial infarction or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Tesaro, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

niraparib; dostarlimab; Radiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Limitations and Caveats

A two-stage design was used, requiring disease control in at least one of the first 15 patients before proceeding to the full accrual of 25 patients.

Results Point of Contact

• Title: Theodore Hong, MD
• Organization: Massachusetts General Hospital

TSHONG1@mgh.harvard.edu

617-726-6050

Study Officials

• Julie L Koenig, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: July 23, 2020
• Primary Completion: January 19, 2022
• Study Completion: February 25, 2022
• Last Updated: August 15, 2025
• Results First Posted: July 3, 2023

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)