Combining the Immunotherapy Dostarlimab and PARP Inhibitor Niraparib for Advanced or Metastatic Breast, Ovarian or Pancreatic Cancer with an Inherited or Tumor BRCA Mutation

About the Study

This study is looking at the effectiveness of combining a PARP inhibitor called niraparib and an immunotherapy called dostarlimab for treating people with an inherited BRCA mutation (found with genetic testing) or a tumor mutation (found through tumor testing) who have breast, pancreatic, ovarian, fallopian tube or primary peritoneal cancer that is metastatic or advanced and cannot be removed by surgery (unresectable).

What the Study Involves

• During the first cycle, participants will receive niraparib orally once daily for 28 days.
• During cycles 2, 3, 4, and 5, participants will receive dostarlimab intravenously on day 1 and niraparib orally once daily for 21 days.
• During cycle 6, participants will receive dostarlimab intravenously on day 1 and niraparib orally once daily for 42 days. Cycles repeat every 42 days for up to 24 months as long as the cancer doesn’t get worse and there are no unacceptable side effects. 

After completion of study treatment, participants are followed for up to 30 days, every 6 months for 2 years, and then annually for up to 5 years.

Study Location

Washington
Seattle
Fred Hutch/University of Washington Cancer Consortium
Contact: Elizabeth M. Swisher
1-206-543-3669 or by email at: swishere@uw.edu

People with the following may be eligible:

• diagnosed with breast, ovarian, fallopian tube, primary peritoneal or pancreatic cancer that is locally advanced or metastatic.
• cancer has gotten worse after standard therapies.
• people with stable brain metastases may be eligible if they have had no symptoms, steroids, or anti-seizure medications for at least 7 days.
• have an inherited BRCA mutation (found with genetic testing) or a tumor mutation (found through tumor testing).
• able and willing to have tumor biopsies.
• prior treatment with a PARP inhibitor is allowed if participant has not had previous treatment with immunotherapy.
• prior treatment with immunotherapy is allowed if participant has not had previous treatment with a PARP inhibitor.

Check study listing on clinicaltrials.gov for full eligibility.

Participants with the following may not be eligible:

• must not have had major surgery within 3 weeks of starting the study and must have recovered from any surgical effects.
• must not have received prior treatment with both a PARP inhibitor and immunotherapy (either sequentially or together). Participants may have had either a PARP inhibitor or immunotherapy treatment previously but not within 3 months of starting treatment
  • participant who received a prior immunotherapy must not have had an adverse event on it. 
• people with other medical conditions or prior cancer may not be eligible, including
  • prior cancer diagnosis (with exception for skin, cervical or a BRCA-related cancer), bowel obstruction, immunodeficiency hepatitis B or C.

Check study listing on clinicaltrials.gov for full eligibility.