Recurrent Cervix CancerPhase 2STARNCT04068753
Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer
A Phase 2 study testing Niraparib and dostarlimab in people with Recurrent Cervix Cancer and Progressive Cervix Cancer, run by University of Oklahoma at 4 sites in United States.
Trial summary
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Cervix Cancer, Progressive Cervix Cancer
- What is being tested?
- Niraparib and dostarlimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2020to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is female at least 18 years of age.
- Patient has histologically proven cervical cancer, which is recurrent or progressive
- Patient has archival tumor tissue available or a fresh biopsy of recurrent or persistent tumor must be obtained prior to study treatment initiation. Availability of tissue does not affect eligibility of patient on trial, but PD-L1 status and next-generation sequencing data is required to be collected for the trial.
- 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 regimens. Chemotherapy with radiation is not considered systemic treatment. Prior treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapies is allowed; however, these treatments could not have been discontinued due to immune related adverse events and patient cannot have progressed while on anti-PD-1, anti-PD-L1 or anti PD-L2 given in combination with chemotherapy or while on maintenance immunotherapy.
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- Patient has adequate organ function, defined per protocol.
- Patient is able to take oral medications.
- Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- If of childbearing potential, has a negative pregnancy test within 7 days prior to taking study medication or agrees to abstain from activities that could result in pregnancy from enrollment through 180 days after the last dose of study treatment, or be of non- childbearing potential.
Who cannot join
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable for at least 4 weeks prior to the first dose of study treatment and have not been using steroids for at least 7 days prior to study treatment.
- Known additional malignancy that required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
- Patient is considered a poor medical risk that would interfere with cooperation with the requirements of the study.
- Received a transfusion (platelets or red blood cells) ≤4 weeks prior to initiating protocol therapy.
- 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 chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
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- Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
- Pregnant or breastfeeding or expecting to conceive children within the projected duration 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 other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy, and ≤ 10mg a day prednisone or equivalent.
- Known history of human immunodeficiency virus (HIV) (HIV ½ 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 immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Not recovered to ≤Grade 1 or to baseline from chemotherapy induced AEs. Note: Patient with ≤ Grade 1 neuropathy or ≤ Grade 2 alopecia is an exception to this criterion and may qualify for the study.
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Prior cytotoxic chemotherapy, anticancer targeted small molecules (e.g., tyrosine kinase 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 to study Day 1 or radiation therapy encompassing > 20% of the bone marrow within 2 weeks, 1 week for radiation therapy encompassing ≤ 20%.
- Major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- 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 the exception of non-clinically significant lab abnormalities: any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome), or myocarditis of any grade.
- History of interstitial lung disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase II Trial of Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (OU-SCC-STAR)
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer.
Read the detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial. If found 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 treatment completion for up to 5 years.
- Conditions
- Recurrent Cervix Cancer, Progressive Cervix Cancer
- Being tested
- Niraparib, dostarlimab
- Keywords
- Cervix Cancer, Niraparib, dostarlimab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Niraparib: 200 mg, oral, once daily, days 1-21
dostarlimabDrug
dostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years
| Study group | Role | What they receive |
|---|---|---|
| Niraparib + dostarlimab | Experimental | Not described Receives: Drug: Niraparib; Drug: dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with response to treatment
The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1
Measured: 1 year
Secondary outcomes (4)
Number of patients who experience toxicity
To determine the nature and degree of toxicity in combination of Niraparib and dostarlimab
Measured: 2 years
Duration of patients with response
To estimate the duration of response of patients treated with combination of Niraparib and dostarlimab
Measured: up to 5 years
Progression free survival
To estimate the progression free survival of patients treated with combination of Niraparib and dostarlimab
Measured: up to 5 years
Overall survival
To estimate the overall survival of patients treated with combination of Niraparib and dostarlimab
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Feb 2020
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Cervix CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Sponsor
- Investigators
- Debra Richardson, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068753
- Sponsor's protocol ID
- OU-SCC-STAR
- Other IDs
- OU-SCC-TESARO-002
- Acronym
- STAR
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (OU-SCC-STAR)
- ClinicalTrials.gov ID
- NCT04068753
- Acronym / sponsor ID
- STAR / OU-SCC-STAR
- Conditions
- Recurrent Cervix Cancer, Progressive Cervix Cancer
- Keywords
- Cervix Cancer, Niraparib, dostarlimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer.
Detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial. If found 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 treatment completion for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib + dostarlimab | Experimental | Drug: Niraparib, Drug: dostarlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is female at least 18 years of age.
- Patient has histologically proven cervical cancer, which is recurrent or progressive
- Patient has archival tumor tissue available or a fresh biopsy of recurrent or persistent tumor must be obtained prior to study treatment initiation. Availability of tissue does not affect eligibility of patient on trial, but PD-L1 status and next-generation sequencing data is required to be collected for the trial.
- Patient has measurable lesions by RECIST v1.1.
- Patient has an ECOG performance status of 0 to 1.
Key exclusion criteria (22 listed)
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable for at least 4 weeks prior to the first dose of study treatment and have not been using steroids for at least 7 days prior to study treatment.
- Known additional malignancy that required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
- Patient is considered a poor medical risk that would interfere with cooperation with the requirements of the study.
- Received a transfusion (platelets or red blood cells) ≤4 weeks prior to initiating protocol therapy.
- Received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibNiraparib: 200 mg, oral, once daily, days 1-21 | Drug | Niraparib + dostarlimab |
| dostarlimabdostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years | Drug | Niraparib + dostarlimab |
Primary outcome
Proportion of patients with response to treatment
Time frame: 1 year
The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1
4 secondary outcomes
Number of patients who experience toxicity
Time frame: 2 years
Duration of patients with response
Time frame: up to 5 years
Progression free survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Richardson, MD principal investigator
Stephenson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib and dostarlimab in people with Recurrent Cervix Cancer and Progressive Cervix Cancer, run by University of Oklahoma at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with response to treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.