Immunotherapy and PARP Inhibitor for Advanced or Metastatic Breast, Ovarian or Pancreatic Cancer with a BRCA Mutation
Clinicaltrials.gov identifier:
NCT04673448
Treatment
Treatment study for people with advanced breast, ovarian or pancreatic cancer and an inherited or tumor BRCA mutation
Study Contact Information:
For additional information, please contact:
Principal Investigator: Elizabeth M. Swisher
Fred Hutch/University of Washington Cancer Consortium
1-206-543-3669 or by email at: [email protected]
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 called and an called dostarlimab for treating people with an inherited mutation (found with genetic testing) or a tumor mutation (found through tumor testing) who have breast, pancreatic, ovarian, or primary peritoneal cancer that is or advanced and cannot be removed by surgery (unresectable).
What the Study Involves
- During the first cycle, participants will receive orally once daily for 28 days.
- During cycles 2, 3, 4, and 5, participants will receive dostarlimab intravenously on day 1 and orally once daily for 21 days.
- During cycle 6, participants will receive dostarlimab intravenously on day 1 and 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: [email protected]
People with the following may be eligible:
- diagnosed with breast, ovarian, , primary peritoneal or pancreatic cancer that is locally advanced or .
- 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 mutation (found with genetic testing) or a tumor mutation (found through tumor testing).
- able and willing to have tumor biopsies.
- prior treatment with a is allowed if participant has not had previous treatment with .
- prior treatment with is allowed if participant has not had previous treatment with a .
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 and (either sequentially or together). Participants may have had either a or treatment previously but not within 3 months of starting treatment
- participant who received a prior must not have had an 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.