Endometrial CancerPhase 2NCT03016338
Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer
A Phase 2 study testing Niraparib and TSR-042 in people with Endometrial Cancer, run by University Health Network, Toronto at 7 sites in Canada.
Trial summary
This is a phase 2 study of investigational drug niraparib and TSR-042 in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in patients with recurrent endometrial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Niraparib and TSR-042
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 7 sitesCanada
- Study dates
- 6 Nov 2017to Dec 2026
- 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
- Histologically confirmed epithelial endometrial cancer. All histological subtypes are allowed except for endometrial sarcoma, carcinosarcoma, clear cell, mixed and adenosquamous tumors.
- Patients must have radiographic evidence of disease progression following the most recent line of treatment.
- Patients must have previously received at least one line of platinum-based chemotherapy. Prior hormonal and immunotherapy are allowed. There is no restriction on the total number prior lines of therapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥10 mm with CT scan, MRI, or calipers by clinical exam, and ≥15mm for nodal lesions. Areas of previous radiation may not serve as measurable disease unless there is evidence of progression post radiation.
- Patients must have archival tumor sample available for PTEN analysis. If archival tissue is not available, the patient will have the option to undergo tumor biopsy.
- Eastern Cooperative Group (ECOG) performance status ≤ 2.
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- Life expectancy of greater than 12 weeks.
- Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function.
- Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy
- Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment
Who cannot join
- Chemotherapy or biologic agents received within 4 weeks of starting study treatment.
- Hormonal therapy within 2 weeks of starting study treatment.
- Pelvic radiotherapy (as treatment of primary disease) within 4 weeks, or palliative radiotherapy encompassing >20% of the bone marrow within 1 week of starting study treatment.
- Previous treatment with a PARP inhibitor, or any other targeted therapy directed against the homologous recombination pathway.
- Patients who are receiving any other investigational agents.
- Ongoing ≥ Grade 2 toxicities related to prior cancer therapy, with the exceptions of alopecia, neuropathy, lymphopenia and skin depigmentation.
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- Received transfusion (platelets or red blood cells) ≤4 weeks of the first dose of study treatment.
- Major surgery within 4 weeks of registration or ongoing clinically significant post-surgical complications. Study biopsy is not considered major surgery.
- Known brain metastases, except if stable for greater than 28 days following definitive treatment. The patient must have no new or progressive signs or symptoms related to the CNS disease and must be either off or taking a stable dose of corticosteroids. A scan to confirm the absence of brain metastases is not required.
- History of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- History of bowel obstruction within 3 months, or other reason preventing effective oral administration of medication.
- Immunocompromised patients e.g. Human Immunodeficiency Virus (HIV) requiring treatment or active Hepatitis B or C. Prior splenectomy is allowed.
- Uncontrolled inter-current illness.
- History of other malignancy ≤ 3 years prior to registration with the exceptions of a) cone-biopsied in situ carcinoma of the cervix uteri; b) basal or squamous cell carcinoma of the skin. All second malignancies in this context should be discussed with the Principal Investigator.
- Previous treatment with anti PD-1, anti PD-L1, anti PD-L2, anti CTLA4 agents
- History of fistula, or high-risk of developing a fistula.
- Diagnosis of immunodeficiency or systemic steroid therapy or other form of immunosuppressive therapy within 7 days prior to initiating the protocol therapy.
- Known history of human immunodeficiency virus (type 1 or 2 antibodies).
- Known active hepatitis (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
- Active autoimmune disease that has required systemic treatment in the past 2 years (ie, 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.
- History of interstitial lung disease
- Received a live vaccine within 14 days of initiating protocol therapy
- History of ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
London Regional Cancer Centre
London, Ontario, N6A 4L6
McGill University Health Centre - Glen Site
Montreal, Quebec, H3A 3J1
Sunnybrook Research Institute, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1M9
About this study
Official title: A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib in Monotherapy or in Combination With Anti-PD1 Inhibitor TSR-042 in Recurrent Endometrial Cancer
This is a phase 2 study of investigational drug niraparib and TSR-042 in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in patients with recurrent endometrial cancer, as well as to explore the possible impact of phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking PARP with niraparib.
Read the detailed description
The purpose of this trial is to elucidate whether the PARP inhibition approach with niraparib, or the combination of niraparib and TSR-042, provides clinical benefit in patients with recurrent endometrial cancer.
The trial is designed as a multicenter, open-label, phase II study of niraparib in monotherapy or in combination with anti-PD1 inhibitor TSR-042 in recurrent endometrial cancer. Patients must have received prior platinum based chemotherapy.
The study will initially enroll patients with recurrent endometrial cancer to the niraparib monotherapy cohort not selected according to the PTEN status (cohort I).
Once the initial assessment with niraparib monotherapy is completed (inclusion of 22 evaluable patients),Additional 22 patients will be enrolled in the combination arm with niraparib and TSR-042 (cohort II).
Eligible participants will take niraparib capsules or tablets by mouth 300/200 mg, once a day, every day of every 21 day cycle.Participant will receive TSR-042 500 mg( intravenously) on the first day of each cycle for cycle 1 to 4. Followed by 1000 mg every 2 cycle for every 6 weeks for maximum of 2 yrs.
While receiving the study treatment, participants will be asked to visit the study site on Days 1, 8, 15 of Cycle 1.Cycle 2 onward Days 1 and 15 and future cycles for safety tests and procedures. If, at any time, participants develop (or is suspected to have developed) MDS/AML, a mandatory bone marrow aspirate/biopsy will be done for testing to confirm diagnosis.
When participants are taken off the study treatment permanently, they will be asked to return to the study site for an End of Study Treatment visit to have tests and procedures done for safety purposes.
Participants who are taken off the study treatment for any reason other than disease progression will continue to have radiological assessments every 8 weeks until disease progression. Participants will continue to be followed up for side effects weekly in the first 4 weeks, then monthly until resolution.
- Conditions
- Endometrial Cancer
- Being tested
- Niraparib, TSR-042
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Also called MK4827
200 or 300 mg daily PO, for 21 day cycle
TSR-042Drug
Also called Dostarlimab
500 mg once intravenously on day 1 of cycle (From cycle 1-4 followed by 1000 mg intravenously every 6 weeks for maximum of 2 yrs)
| Study group | Role | What they receive |
|---|---|---|
| Niraparib +TSR-042 | Experimental | 200/300 mg Niraparib by mouth once a day for 21 days cycle. 500 mg of TSR-042 intravenously on the first day of each cycle. Receives: Drug: Niraparib; Drug: TSR-042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the antitumor activity according to RECIST v 1.1
To determine the antitumor activity of single agent niraparib and of niraparib in combination with TSR-042 in women with metastatic endometrial cancer who has received prior platinum-based chemotherapy via assessment of clinical benefit rate (complete response, partial response or stable disease ≥16 weeks), according to RECIST v 1.1.
Measured: 16 weeks
Secondary outcomes (5)
Number of side effects
To assess the safety and tolerability of single agent niraparib and of niraparib in combination with TSR-042.
Measured: 5 years
Overall response rate
Overall response rate (ORR) is defined as the proportion of subjects in the analysis population who have complete response (CR) or partial response (PR) at any time during the study using RECIST
Measured: 5 years
Duration of response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.
Measured: 5 years
Progression free survival rate
Progression free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. If such an event is not observed after 6 months of follow up, patients are censored.
Measured: 5 years
Overall survival rate
Overall survival time (OS) is defined as the time of registration to the date of death by any cause. Following the treatment discontinuation visit, survival status will be collected for all patients using acceptable means including telephone contact.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start6 Nov 2017
- Primary completion5 Jan 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Sponsor
- Investigators
- Amit M Oza, M.D., Study director, UHN - Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016338
- Sponsor's protocol ID
- NEC
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2017
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib in Monotherapy or in Combination With Anti-PD1 Inhibitor TSR-042 in Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03016338
- Acronym / sponsor ID
- NEC
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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.
This is a phase 2 study of investigational drug niraparib and TSR-042 in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in patients with recurrent endometrial cancer, as well as to explore the possible impact of phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking PARP with niraparib.
Detailed description
The purpose of this trial is to elucidate whether the PARP inhibition approach with niraparib, or the combination of niraparib and TSR-042, provides clinical benefit in patients with recurrent endometrial cancer.
The trial is designed as a multicenter, open-label, phase II study of niraparib in monotherapy or in combination with anti-PD1 inhibitor TSR-042 in recurrent endometrial cancer. Patients must have received prior platinum based chemotherapy.
The study will initially enroll patients with recurrent endometrial cancer to the niraparib monotherapy cohort not selected according to the PTEN status (cohort I).
Once the initial assessment with niraparib monotherapy is completed (inclusion of 22 evaluable patients),Additional 22 patients will be enrolled in the combination arm with niraparib and TSR-042 (cohort II).
Eligible participants will take niraparib capsules or tablets by mouth 300/200 mg, once a day, every day of every 21 day cycle.Participant will receive TSR-042 500 mg( intravenously) on the first day of each cycle for cycle 1 to 4. Followed by 1000 mg every 2 cycle for every 6 weeks for maximum of 2 yrs.
While receiving the study treatment, participants will be asked to visit the study site on Days 1, 8, 15 of Cycle 1.Cycle 2 onward Days 1 and 15 and future cycles for safety tests and procedures. If, at any time, participants develop (or is suspected to have developed) MDS/AML, a mandatory bone marrow aspirate/biopsy will be done for testing to confirm diagnosis.
When participants are taken off the study treatment permanently, they will be asked to return to the study site for an End of Study Treatment visit to have tests and procedures done for safety purposes.
Participants who are taken off the study treatment for any reason other than disease progression will continue to have radiological assessments every 8 weeks until disease progression. Participants will continue to be followed up for side effects weekly in the first 4 weeks, then monthly until resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib +TSR-042 | Experimental | Drug: Niraparib, Drug: TSR-042200/300 mg Niraparib by mouth once a day for 21 days cycle. 500 mg of TSR-042 intravenously on the first day of each cycle. |
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)
- Histologically confirmed epithelial endometrial cancer. All histological subtypes are allowed except for endometrial sarcoma, carcinosarcoma, clear cell, mixed and adenosquamous tumors.
- Patients must have radiographic evidence of disease progression following the most recent line of treatment.
- Patients must have previously received at least one line of platinum-based chemotherapy. Prior hormonal and immunotherapy are allowed. There is no restriction on the total number prior lines of therapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥10 mm with CT scan, MRI, or calipers by clinical exam, and ≥15mm for nodal lesions. Areas of previous radiation may not serve as measurable disease unless there is evidence of progression post radiation.
- Patients must have archival tumor sample available for PTEN analysis. If archival tissue is not available, the patient will have the option to undergo tumor biopsy.
Key exclusion criteria (23 listed)
- Chemotherapy or biologic agents received within 4 weeks of starting study treatment.
- Hormonal therapy within 2 weeks of starting study treatment.
- Pelvic radiotherapy (as treatment of primary disease) within 4 weeks, or palliative radiotherapy encompassing >20% of the bone marrow within 1 week of starting study treatment.
- Previous treatment with a PARP inhibitor, or any other targeted therapy directed against the homologous recombination pathway.
- Patients who are receiving any other investigational agents.
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 |
|---|---|---|
| NiraparibAlso: MK4827200 or 300 mg daily PO, for 21 day cycle | Drug | Niraparib +TSR-042 |
| TSR-042Also: Dostarlimab500 mg once intravenously on day 1 of cycle (From cycle 1-4 followed by 1000 mg intravenously every 6 weeks for maximum of 2 yrs) | Drug | Niraparib +TSR-042 |
Primary outcome
To determine the antitumor activity according to RECIST v 1.1
Time frame: 16 weeks
To determine the antitumor activity of single agent niraparib and of niraparib in combination with TSR-042 in women with metastatic endometrial cancer who has received prior platinum-based chemotherapy via assessment of clinical benefit rate (complete response, partial response or stable disease ≥16 weeks), according to RECIST v 1.1.
5 secondary outcomes
Number of side effects
Time frame: 5 years
Overall response rate
Time frame: 5 years
Duration of response
Time frame: 5 years
Progression free survival rate
Time frame: 5 years
Overall survival rate
Time frame: 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 23 Jun 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.
Amit M Oza, M.D. study director
UHN - Princess Margaret Cancer Centre
7 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 TSR-042 in people with Endometrial Cancer, run by University Health Network, Toronto at 7 sites in Canada.
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 23 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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?
To determine the antitumor activity according to RECIST v 1.1 (time frame: 16 weeks). 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 23 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.