Avelumab and M1774 in ARID1A-mutated Endometrial Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPanagiotis Konstantinopoulos, MD, PhD

About this trial

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)

Eligibility criteria

Qualifiers

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 principal investigator prior to participant enrollment.

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 for nodal lesions). Each lesion must be >= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.

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 and radiation therapy, and/or consolidation/maintenance therapy. Furthermore, patients who have only received chemotherapy with immunotherapy in the adjuvant setting will be eligible for the study.

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 this requirement may enroll in the study.

Disqualifiers

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 period for hormonal therapy.

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 investigator (e.g., alopecia, sensory neuropathy ≤ Grade 2, etc.)

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 > 14 days or are on a stable or decreasing steroid dose (for the treatment of brain metastases) may be enrolled. Participants with meningeal carcinomatosis are excluded.

Trial design

Treatments tested in this trial

  • Avelumab
  • M1774

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Panagiotis Konstantinopoulos, MD, PhD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

EMD Serono

Collaborator

The Applebaum Foundation

Collaborator