Study of REGN2810 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, for which there is not a
curative intent option (surgery or radiation therapy with or without chemotherapy).
Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous
carcinoma. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.

2. Tumor progression or recurrence within 6 months of last dose of platinum therapy that
was 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 not
administered

8. Received prior paclitaxel therapy or had clinically documented reason why not
administered

Key Exclusion Criteria:

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

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

3. Prior treatment with systemic immune modulating agents (other than anti-PD-1/PD-L1
agents) that was within 28 days prior to enrollment, or within 90 days prior to
enrollment if there was an immune related adverse event, or associated with toxicity
that resulted in discontinuation of the immune modulating agent

4. Active or untreated brain metastases

5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
4 weeks prior to the first dose of study drug (REGN2810 [cemiplimab] or IC chemo

6. Active infection requiring therapy

7. History of pneumonitis within the last 5 years

8. Documented allergic or acute hypersensitivity reaction attributed to antibody
treatments

9. Concurrent malignancy other than cervical cancer and/or history of malignancy other
than cervical cancer within 3 years of first planned dose of study drug (REGN2810
[cemiplimab] or IC chemo, except for tumors with negligible risk of metastasis or
death. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are
excluded.

Note: Other protocol defined Inclusion/Exclusion may apply