Niraparib + TSR-042 for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining two drugs, niraparib (a PARP inhibitor) and TSR-042 (dostarlimab, an immunotherapy drug), can benefit individuals with advanced endometrial cancer that has recurred after treatment. The study examines the potential benefits of blocking a specific protein for patients with this cancer type. Individuals whose endometrial cancer worsened after treatment and who have tried at least one type of platinum-based chemotherapy may be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop chemotherapy or biologic agents 4 weeks before starting, and hormonal therapy 2 weeks before starting. If you're on corticosteroids, you can continue as long as your dose is stable for at least 4 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of niraparib and TSR-042 (dostarlimab) is being tested for safety and effectiveness in treating advanced endometrial cancer. Previous studies found that this combination can significantly extend the time before the cancer worsens.
Regarding safety, past studies showed that this combination is generally well-tolerated by patients. However, like many cancer treatments, some side effects have been reported, including tiredness, nausea, and low blood cell counts. Patients should discuss potential side effects with their doctor, as reactions to treatment can vary.
Overall, research suggests that the combination of niraparib and TSR-042 is promising in terms of safety, but individual experiences may differ.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Niraparib + TSR-042 for endometrial cancer because it offers a novel approach compared to standard treatments like chemotherapy, surgery, and radiation. Niraparib is a PARP inhibitor that works by interfering with cancer cell DNA repair, potentially leading to cancer cell death. TSR-042 (also known as dostarlimab) is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. This combination targets both the cancer cells directly and boosts the body's immune response, which could lead to improved outcomes for patients.
What evidence suggests that niraparib and TSR-042 could be effective for endometrial cancer?
Research has shown that using niraparib with TSR-042 (dostarlimab) may help treat endometrial cancer. In this trial, participants will receive this combination treatment. One study found that this combination significantly increased the time patients lived without their cancer worsening, specifically for those with advanced or recurrent endometrial cancer. This suggests these drugs might slow or stop cancer growth. Another study demonstrated some positive effects, indicating potential benefits in cancer treatment. Overall, these treatments show promising results for people with advanced stages of this cancer.13678
Who Is on the Research Team?
Amit M Oza, M.D.
Principal Investigator
UHN - Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
This trial is for patients with advanced or recurrent endometrial cancer who have had at least one platinum-based chemotherapy. They must show disease progression, have a performance status ≤ 2, and measurable disease. Exclusions include those with certain medical conditions like fistulas, lung diseases, recent transfusions or surgeries, MDS/AML history, bowel obstruction within 3 months, immunodeficiency including HIV/Hepatitis B/C active infections, brain metastases unless stable over 28 days without steroids needed for control of symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib monotherapy or in combination with TSR-042. Niraparib is taken daily, and TSR-042 is administered intravenously on specific days of the cycle.
End of Study Treatment
Participants undergo tests and procedures for safety purposes after discontinuing study treatment.
Follow-up
Participants are monitored for side effects and undergo radiological assessments every 8 weeks until disease progression. Follow-up for side effects is weekly for the first 4 weeks, then monthly until resolution.
What Are the Treatments Tested in This Trial?
Interventions
- Niraparib
- TSR-042
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Tesaro, Inc.
Industry Sponsor