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New treatment option for Endometrial Cancer
Official title Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery
ClinicalTrials.gov ID: NCT04774419
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as TSR-042.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will test whether the combination of radiation and Dostarlimab is an effective treatment for women with MMR-D/MSI-H endometrial cancer who have recently undergone surgery.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age 18 years or older
- ECOG performance status 0-1
- Endometrial cancer: all histologies (submission of pathology report is required for all patients who underwent surgery outside of MSK)
- MMR-D or MSI-H or POLE-mutated (submission of report(s) required for. patients who underwent testing outside of MSK POLE-mutated endometrial cancers...
- Patients with hypermethylation of MMR gene promoters (MLH1, MSH2, MSH6 or PMS2) will be included
You likely can't join if
- Has had prior chemotherapy, targeted therapy, or investigational therapy for endometrial cancer. °Patients who have received prior chemotherapy...
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent for endometrial cancer.
- Unfit for Radiation Therapy due to the following:
- Has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol...
- Patients with a prior history of pelvic radiation
- Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
See the full eligibility criteria
Who can join
- Age 18 years or older
- ECOG performance status 0-1
- Endometrial cancer: all histologies (submission of pathology report is required for all patients who underwent surgery outside of MSK)
- MMR-D or MSI-H or POLE-mutated (submission of report(s) required for. patients who underwent testing outside of MSK POLE-mutated endometrial cancers will be included regardless of MMR/MSI status and limited to up to 3...
- Patients with hypermethylation of MMR gene promoters (MLH1, MSH2, MSH6 or PMS2) will be included
- POLE-mutated endometrial cancers will be included
- Must have undergone a complete surgical staging and have stage III/IVA disease.
- Patients with measurable disease (RECIST 1.1) after surgery are NOT eligible.
- PatienSurgery completed between 3 weeks and 12 weeks (inclusive) before cycle 1 day 1 of therapy, and must have adequately recovered from surgery and any complications of surgery.ts with isolated tumor cells in lymph...
- Surgery completed between 3 weeks and 12 weeks (inclusive) before cycle 1 day 1 of therapy, and must have adequately recovered from surgery and any complications of surgery.
- Has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential, and agrees use an adequate method of contraception from screening through 150 days after the last dose of...
- Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal...
- Participant must agree to not breastfeed during the study or for 150 days after the last dose of study treatment.
- Demonstrate adequate organ function as defined below. All screening labs should be performed within 14 days of treatment initiation.
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥9 g/dL
- Creatinine Clearance GFR ≥ 45
- Serum total bilirubin ≤ 1.5 X ULN (patients with known Gilbert's disease Serum total bilirubin who have bilirubin level ≤ 3 x ULN may be enrolled)
- AST and ALT 3 ULN OR ≤ 5 X ULN for people with liver metastases
- TSH within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal free T4 level is required.
What rules you out
- Has had prior chemotherapy, targeted therapy, or investigational therapy for endometrial cancer. °Patients who have received prior chemotherapy, targeted therapy, or other investigational therapies for other cancers and...
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent for endometrial cancer.
- Unfit for Radiation Therapy due to the following:
- Has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
- Patients with a prior history of pelvic radiation
- Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
- Any hematological abnormality or disorder that would be a contraindication to radiation per the treating physician.
- Hypersensitivity to Dostarlimab or any of its excipients
- Patients with diagnosis of immunodeficiency or patients receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- Total systemic steroid dose cannot exceed an equivalent of 10mg of prednisone daily and dose must be stable for at least 4 weeks prior to initiating protocol therapy
- Has active TB (Bacillus tuberculosis)
- Has evidence of active, non-infectious pneumonitis.
- Has history of interstitial lung disease
- Has an active infection requiring systemic therapy with intravenous antibiotics
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves'...
- people with vitiligo or alopecia
- people with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- people with psoriasis not requiring systemic treatment.
- people with history of immune-related hyperthyroidism with total thyroidectomy currently in remission
- Select situations after approval of study PI
- Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Has received a live vaccine within 30 days of planned start of study therapy. °Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza...
- Is unwilling to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study. The use of LAR for cognitively impaired patients is not permitted.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.