Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (STAR)
S
Sharon E. Robertson
Primary Investigator
Enrolling By Invitation
18 years and older
Female
Phase
2
66 participants needed
2 Locations
Overview
What is the purpose of this study?
The purpose of this research study is to test the safety of Niraparib and dostarlimab as abination treatment and see what effects (good and bad) this combination treatment has onwith recurrent or progressive cervix cancer.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
- Patients will have tests and exams to see if they are eligible for the clinical trial. Ifund eligible, the patient will receive treatment with Niraparib daily and dostarlimab by vein every three weeks for 4 cycles then every six weeks.
- Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.
- Patients will be monitored during treatment with tests and exams and after treatmentup to 5 years.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Recurrent Cervix Cancer, Progressive Cervix Cancer
-
Age: 18 Years
-
Gender: Female
Inclusion Criteria:
- Patient is female at least 18 years of age.
- Patient has histologically proven recurrent or progressive cervix cancer
- Patient has archival tumor tissue available or a fresh biopsy of recurrent orumor must be obtained prior to study treatment initiation.
- Patient has measurable lesions by RECIST v1.1.
- Patient has an ECOG performance status of 0 to 1.
- Patients must have received at least one or more prior systemic treatment regimen.Chemotherapy with radiation is not considered systemic treatment.
- Patient has adequate organ function, defined per protocol
- Patient is able to take oral medications.
- Participant receiving corticosteroids may continue as long as their dose is stable forweeks prior to initiating protocol therapy.
- Participant must agree to not donate blood during the study or for 90 days after thedose of study treatment.
- If of childbearing potential, has a negative pregnancy test within 7 days prior toking study medication or agrees to abstain from activities that could result ingnancy from enrollment through 180 days after the last dose of study treatment, orbe of non-childbearing potential.
Exclusion Criteria:
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.: Patients with previously treated brain metastases may participate provided theyble for at least 4 weeks prior to the first dose of study treatment, and havebeen using steroids for at least 7 days prior to study treatment.
- Known additional malignancy that required active treatment within the last 2 years.ude basal cell carcinoma of the skin or squamous cell carcinoma of thekin.
- Patient is considered a poor medical risk that would interfere with cooperation withhe requirements of the study.
- Received a transfusion (platelets or red blood cells) ≤4 weeks prior to initiatingherapy.
- Received colony stimulating factors (eg, granulocyte colony-stimulating factor,granulocyte macrophage colony stimulating factor, or recombinant erythropoietin)within 4 weeks prior initiating protocol therapy.
- Known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapyhat persisted > 4 weeks and was related to the most recent treatment.
- Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active,uncontrolled infection.
- Pregnant or breastfeeding, or expecting to conceive children within the projectedduration of the study and for 180 days after the last dose of study treatment.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any otherunosuppressive therapy within 7 days prior to the first dose of study.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Known active hepatitis B or hepatitis C.
- Active autoimmune disease that has required systemic treatment in the past 2 years(i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressivedrugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroidherapy for adrenal or pituitary insufficiency, etc.) is not considered aystemic treatment.
- Not recovered to ≤Grade 1 or to baseline from chemotherapy induced AEs. Note: Patientwith ≤ Grade 1 neuropathy or ≤ Grade 2 alopecia is an exception to this criterion andy qualify for the study.
- Currently participating and receiving study therapy or has participated in a study ofvestigational agent and received study therapy or used an investigational devicewithin 4 weeks of the first dose of treatment.
- Prior cytotoxic chemotherapy, anticancer targeted small molecules (e.g., tyrosinekinase inhibitors), hormonal agents within 5 half-lives, or monoclonal antibodies(mAb) within 5 half-lives or 4 weeks (whichever is shorter) of that treatment prior toudy Day 1 or radiation therapy encompassing > 20% of the bone marrow within 2 weeksy radiation therapy within 4 weeks prior to study Day 1.
- Major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must havevered from any surgical effects.
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Received a live vaccine within 14 days of planned start of study therapy.
- Prior treatment with a known PARP inhibitor.
- Known hypersensitivity to niraparib or Dostarlimab components or excipients.
- Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with they significant lab abnormalities.
- History of interstitial lung disease.
Updated on
01 Aug 2024.
Study ID: OU-SCC-STAR, CTO-OUSCC-STAR-IIT, 17285
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