Study of Cemiplimab in Adults With Cervical Cancer

The criteria listed below are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

Key Inclusion Criteria:

1. Recurrent, persistent, and/or metastatic cervical cancer with squamous cellhistology, for which there is not a curative-intent option (surgery or radiationtherapy with or without chemotherapy).

• Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamouscarcinoma) as defined in the protocol

2. Tumor progression or recurrence after treatment with platinum therapy (must havebeen used to treat metastatic, persistent, or recurrent cervical cancer)

3. Patient must have measurable disease as defined by RECIST 1.1.

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

5. ≥18 years old

6. Adequate organ or bone marrow function

7. Received prior bevacizumab therapy or had clinically documented reason why notadministered

8. Received prior paclitaxel therapy or had clinically documented reason why notadministered

Key Exclusion Criteria:

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease thatrequired treatment with systemic immunosuppressive treatments

2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway

3. Prior treatment with other systemic immune-modulating agents that was

4. within fewer than 4 weeks (28 days) of the enrollment date, or

5. associated with irAEs of any grade within 90 days prior to enrollment, or

6. associated with toxicity that resulted in discontinuation of the immunemodulating agent

7. Active or untreated brain metastases

8. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent)within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo)

9. Active infection requiring therapy

10. History of pneumonitis within the last 5 years

11. History of documented allergic reactions or acute hypersensitivity reactionattributed to antibody treatments

12. Concurrent malignancy other than cervical cancer and/or history of malignancy otherthan cervical cancer within 3 years of date of first planned dose of study drugcemiplimab or IC chemo), except for tumors with negligible risk of metastasis ordeath, such as adequately treated cutaneous squamous cell carcinoma or basal cellcarcinoma of the skin or ductal carcinoma in situ of the breast. Patients withhematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.

Note: Other protocol defined Inclusion/Exclusion apply