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PD-1 Inhibitor
Niraparib + Dostarlimab for Endometrial Cancer
Phase 2
Recruiting
Led By Casey Cosgrove, MD
Research Sponsored by Casey Cosgrove
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two drugs to treat uterine serous carcinoma: a PARP inhibitor & a PD-1 inhibitor. They use the patient's own immune system to attack cancer.
Who is the study for?
This trial is for adults with recurrent or persistent uterine serous carcinoma who've had carboplatin/paclitaxel treatment. They should have an ECOG status of <=1, measurable disease by RECIST, and no more than three prior chemo regimens. Prior immunotherapy is allowed if there was no progression/toxicity leading to discontinuation. Participants must not be in other trials, haven't had major surgery within 3 weeks, and recovered from previous treatments' effects.
What is being tested?
The phase II trial tests niraparib (a PARP inhibitor that stops cancer cells from growing) combined with dostarlimab (a PD-1 inhibitor immuno-therapy). The study aims to see if this combination works better for treating patients with uterine serous carcinoma compared to current standard treatments.
What are the potential side effects?
Potential side effects include typical reactions related to immune therapies such as fatigue, nausea, inflammation in organs due to immune response, allergic reactions specific to the drug components or excipients used in the therapy. Side effects can vary based on individual patient health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Secondary study objectives
Clinical benefit rate
Duration of response (DoR)
Incidence of adverse events (AEs)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dostarlimab, niraparib)Experimental Treatment5 Interventions
Patients receive dostarlimab IV and niraparib PO on study. Patients also undergo MRI/CT and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Dostarlimab
2020
Completed Phase 3
~1760
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Niraparib
2018
Completed Phase 4
~2400
Find a Location
Who is running the clinical trial?
Casey CosgroveLead Sponsor
Casey Cosgrove, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had PRES in the past.My blood clotting time is normal or managed with medication.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.My blood clotting time is normal or managed if I'm on blood thinners.My last platinum-based chemotherapy was less than 4 weeks ago.I have never had interstitial lung disease.I've had up to 3 chemotherapy treatments, including one with carboplatin and paclitaxel.I have never worsened on PARP inhibitor or PD1/PDL1 treatment.I haven't had significant radiation therapy affecting my bone marrow recently.My kidney function, measured by creatinine levels, is within the normal range.I haven't taken any colony-stimulating factors in the last 4 weeks.I haven't had a blood transfusion in the last 4 weeks.I have a known history of HIV.I am fully active or have some restrictions but can still care for myself.I have existing tumor samples or can get a new biopsy before starting the study treatment.I agree not to donate blood during the study or for 4 months after it ends.I can take medications by mouth.I am over 45 and have not had a period for more than a year.I've had chemoradiation for initial treatment or a pelvic recurrence, not as a prior chemotherapy line.I don't have any serious health issues that aren't under control.I have had immunotherapy without worsening or severe side effects.I have active hepatitis B or C.I have no history of cancer spreading to my brain or its linings.I had a severe reaction to previous immunotherapy, except for minor lab changes.I have not received a live vaccine in the last 30 days.I have an autoimmune disease but only take replacement hormones like insulin.I have never had myelodysplastic syndrome or acute myeloid leukemia.I have an immune system disorder or have taken immune-weakening medication recently.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I have uterine serous carcinoma that came back or didn't go away after treatment, and I've had carboplatin/paclitaxel.I am 18 years old or older.I haven't had any cancer other than skin or treated cervical cancer in the last 2 years.I am surgically sterile or willing to use two forms of birth control.I have been on a stable dose of corticosteroids less than 10 mg of prednisone or equivalent for at least 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dostarlimab, niraparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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