Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

Key Inclusion Criteria:

1. Disease types under study:

• Part 1: Histologically or cytologically confirmed diagnosis of malignancy withno alternative standard-of-care therapeutic option

• Part 2: Patients with histologically or cytologically documented squamous ornon-squamous NSCLC with stage IIIB or IIIC or stage IV disease who received noprior systemic treatment for recurrent or metastatic NSCLC.

• Patients in Part 2 NSCLC cohorts must have available archival or newly obtainedformalin-fixed tumor tissue from a metastatic/recurrent site, which has notpreviously been irradiated.

2. ECOG (Eastern Cooperative Oncology Group) PS (Performance status) ≤1 (Restricted inphysically strenuous activity but ambulatory and able to carry out work of a lightor sedentary nature [eg, light housework or office work]). Note: Patients with ECOGPS >1 are ineligible.

3. Patients must have been born in Japan, and their biological parents and grandparentsmust all have been of Japanese origin

4. Willing and able to comply with clinic visits and study-related procedures

5. For Part 2, Cohorts D and E: Available tissue for retrospective testing using assayperformed by a central laboratory, as specified in the study manual.

Key Exclusion Criteria:

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease thatrequires treatment with systemic immunosuppressive treatments, which may suggestrisk for Immune-mediated adverse event (imAE)s. The following are not exclusionary:vitiligo, childhood asthma that has resolved, residual hypothyroidism that requiresonly hormone replacement or psoriasis that does not require systemic treatment.

2. Untreated brain metastasis (es) that may be considered active. Patients withpreviously treated brain metastases may participate provided they are stable, thereis no evidence of new or enlarging brain metastases, and the patient does notrequire any systemic corticosteroids for management of brain metastases within 4weeks prior to the first dose of cemiplimab.

3. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent)within 4 weeks prior to the first dose of cemiplimab.

4. Any positive test (ribonucleic acid (RNA) or Deoxyribonucleic acid (DNA) bypolymerase chain reaction) for hepatitis B, hepatitis C, or human immunodeficiencyvirus indicating uncontrolled active or chronic infection.

5. History of pneumonitis or interstitial lung disease

6. Surgery within 1 month of first dose and radiation therapy within 2 weeks of firstdose

7. Completed palliative radiation therapy within the prior 2 weeks or has not recoveredfrom any medically significant radiation-related Adverse Event (AE)

8. Patients that have never smoked, defined as smoking ≤100 cigarettes in a lifetime (Part 2)

9. Patients with tumors tested positive for epidermal growth factor receptor (EGFR)gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS1fusions (Part 2)

Note: Other protocol defined inclusion/exclusion criteria apply.