New drug combo shows promise for Tough-to-Treat uterine cancer
NCT ID NCT03016338
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests two drugs—niraparib and TSR-042 (dostarlimab)—in 51 women with recurrent endometrial cancer that has progressed after platinum chemotherapy. The goal is to see if these drugs can shrink or stabilize tumors. Niraparib blocks a protein that helps cancer cells repair themselves, while TSR-042 boosts the immune system to attack cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- niraparib and dostarlimab (TSR-042)
- What this could lead to
- If successful, this could offer a new treatment option to control recurrent endometrial cancer, potentially slowing tumor growth.
- What could go wrong
- This is an early-phase trial with only 51 participants, so results may not apply to all patients. Side effects from the drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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51 people
The number who actually took part.
- Started
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Nov 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9, Canada
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Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
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London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
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McGill University Health Centre - Glen Site
Montreal, Quebec, H3A 3J1, Canada
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1M9, Canada
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Sunnybrook Research Institute, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
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Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Shorter, personalized radiation may target endometrial cancer with fewer side effects
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a Weight-Loss drug and an IUD treat early uterine cancer without surgery?
- Your gut bacteria may hold the key to whether immunotherapy works
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can an oral drug that starves tumors help Hard-to-Treat cancers?