Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Have a histologically confirmed diagnosis of advanced (unresectable, recurrent, and/or
metastatic) endometrial carcinoma that is incurable and for which prior standard
first-line treatment has failed.
- Prior to Cycle 1 Day 1 (C1D1), documentation of tumor dMMR/MSI-H status must be
available based on local testing.
- Must have progressed on or after at least 1 (but no more than 2) prior line(s) of a
systemic chemotherapy regimen for unresectable and/or metastatic endometrial cancer of
which at least 1 regimen of platinum-based treatment unless participant is ineligible
for or intolerant to platinum.
- Cohort A only: Must be treatment naive for CPIs including PD-1 or PD-L1 inhibitors and
other immune CPIs (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT).
- Cohort B only: Must have received and progressed on or after prior treatment with a
PD-1/PD-L1 inhibitor alone or in combination. Moreover, the participant's duration of
CPI containing treatment and best overall response (BOR) is known, and participant has
received a minimum of 2 cycles of CPI.
Exclusion Criteria:
- Histological diagnosis of carcinosarcoma, malignant mixed M?llerian tumor, endometrial
leiomyosarcoma, or endometrial stromal sarcomas.
- Any prior treatment with any type of antitumor vaccine, or autologous cell
immunotherapy.
- Radiotherapy within 14 days before the planned first dose of trial treatment with
exception of palliative radiotherapy to bone lesions.
- Treatment with an anticancer agent, including investigational vaccines within 28 days
before or 5 times t1/2, whichever is shorter, prior to the planned first dose of trial
treatment or is currently enrolled in an interventional trial.
- Prior treatment with live, attenuated vaccines within 30 days prior to initiation of
trial treatment.
- Received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage
colony-stimulating factor (GM-CSF) support within 4 weeks before the planned first
dose of trial treatment.
- Cohort A only: Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg,
anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell
receptors (eg, 4-1BB, OX40)
- Cohort B only:
- Known history of Grade 3 or higher immune-related adverse events (irAEs) that led
to treatment discontinuation of a prior immunotherapy treatment
- Exposure to any of the following prior therapies/treatments within the specified
timeframes:
- Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg, anti-CTLA-4,
anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg,
4-1BB, OX40)
- PD-1/PD-L1 antibody within 28 days before the planned first dose of trial
treatment.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/27/23. Questions regarding updates should be directed to the study team contact.