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New treatment option for Endometrial Cancer
Official title Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
ClinicalTrials.gov ID: NCT06518564
What this study is testing
What is Avelumab?
Avelumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as MSB0010718C.
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
- The purpose of this research study is to see if the combination of study drugs avelumab and M1774 is effective and safe for participants with endometrial cancer. The names of the study drugs involved in this study are: Avelumab (a type of human IgG1 antibody) M1774 (a type of ATR inhibitor)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- Which group you join is decided by chance.
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
- Participants must have endometrial cancer that is ARID1A-mutated [loss of function (LOF) mutations] determined by any CLIA-certified next-generation...
- Participants must have measurable disease per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension...
- Prior Therapy: There is no upper limit of prior therapies, but patients must have had one prior chemotherapeutic regimen for management of...
- Participants must have received prior immunotherapy targeting the PD-1/PD-L1 pathway either in the adjuvant, first-line or recurrent setting. Up to...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of the combination of avelumab and M1774 in participants...
You likely can't join if
- Participants who have had chemotherapy, immunotherapy, other investigational therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or...
- Participants whose adverse events due to prior anti-cancer therapy have not recovered to ≤ Grade 1, unless toxicity does not constitute a safety risk...
- Participants who are receiving any other investigational agents.
- Participants with clinically controlled brain metastases, which is defined as individuals with central nervous system metastases that have been...
- Known prior severe hypersensitivity to avelumab or M1774 or any component in its formulations, including known severe hypersensitivity reactions to...
- Active and/or uncontrolled infection. The following exceptions apply:
See the full eligibility criteria
Who can join
- Participants must have endometrial cancer that is ARID1A-mutated [loss of function (LOF) mutations] determined by any CLIA-certified next-generation sequencing assay. ARID1A LOF mutation status must be confirmed by the...
- Participants must have measurable disease per RECIST 1.1, 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...
- Prior Therapy: There is no upper limit of prior therapies, but patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy...
- Participants must have received prior immunotherapy targeting the PD-1/PD-L1 pathway either in the adjuvant, first-line or recurrent setting. Up to 50% of participants (i.e. a maximum of 12 participants) who do not meet...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of the combination of avelumab and M1774 in participants \<18 years of age, children are excluded from this study.
- ECOG performance status 0, 1, or 2 (reference Appendix A for ECOG performance status criteria).
- Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue OR 15 unstained 5-micron slides from the original surgery or biopsy or from a biopsy of recurrent disease.
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mcL
- Hemoglobin ≥ 9.0 g/dL (with no erythropoietin or red blood cell transfusion within the last 14 days)
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) in the case of documented Gilbert's syndrome, total bilirubin ≤3 x ULN is allowed
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN in patients with documented hepatic involvement, AST/ALT ≤ 5 x ULN is allowed
- Creatinine clearance ≥ 60 mL/min as estimated by the Cockcroft-Gault formula or institutional standard method OR
- Glomerular filtration rate (GFR) ≥ 60 mL/min by measured 24-hour urine collection
- The effects of avelumab and M1774 on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential must have a negative serum pregnancy...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Participants who have had chemotherapy, immunotherapy, other investigational therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. There is no required washout...
- Participants whose adverse events due to prior anti-cancer therapy have not recovered to ≤ Grade 1, unless toxicity does not constitute a safety risk and/or is stable on supportive therapy in the opinion of the...
- Participants who are receiving any other investigational agents.
- Participants with clinically controlled brain metastases, which is defined as individuals with central nervous system metastases that have been treated for, are asymptomatic, and have discontinued corticosteroids for \>...
- Known prior severe hypersensitivity to avelumab or M1774 or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (≥ Grade 3), any history of anaphylaxis, or...
- Active and/or uncontrolled infection. The following exceptions apply:
- Participants with HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction
- Participants with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels \< ULN, and provided...
- Participants with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day.
- Current or prior use of immunosuppressive medication within 7 days prior to enrollment with the following exceptions to this exclusion criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are...
- History of prior organ transplantation including allogeneic stem-cell transplantation.
- Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of...
- Participants with psychiatric conditions (including active or recent [within the past year] suicidal ideation of behavior)/social situations that, in the judgment of the investigator, would make the participant...
- Participants with uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (≥ New York Heart Association Classification Class III), uncontrolled cardiac arrhythmia, unstable angina...
- Known alcohol or drug abuse.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5...
- All other severe acute or chronic medical conditions (for example, immune colitis, inflammatory bowel disease, uncontrolled asthma, immune pneumonitis, or pulmonary fibrosis) or laboratory abnormalities that may...
- Vaccination within 4 weeks of treatment initiation and while on trial is prohibited except for administration of inactivated vaccines.
- Patients may not use natural herbal products or other "folk remedies" while participating in this study. Herbal medications include, but are not limited to St. John's Wort, Kava, ephedra (ma huang), gingko biloba...
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or CYP1A2 enzymes, proton pump inhibitors, or other prohibited concomitant medications within 7 days prior to...
- Pregnant women are excluded from this study because avelumab and M1774 are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing...
- Calculated QTc average (using the Fridericia correction calculation) of \> 470 msec that does not resolve with correction of electrolyte abnormalities.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Boston, Massachusetts, United States. 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.