An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

Inclusion Criteria

Key Inclusion Criteria for Tumor Collection:

1. Diagnosis or clinical signs of advanced RCC as defined by TNM classification of [any
T, any N, M1].

2. Scheduled for unilateral or partial nephrectomy

Key Exclusion Criteria for Tumor Collection:

1. RCC that does not meet TNM classification of [any T, any N, M1].

2. Known inability to undergo sunitinib treatment as currently labeled, due to
pre-existing medical conditions

3. Requirement for systemic chronic immunosuppressive drugs or corticosteroids

4. Brain metastases detected by MRI or computerized cranial tomography, if central
nervous system scans are available

5. Four or more of the following preoperative risk factors:

1. Albumin < LLN

2. LDH > ULN

3. Symptoms at presentation due to metastases (i.e., bone pain, neurologic
symptoms)

4. Retroperitoneal adenopathy

5. Supradiaphragmatic adenopathy

6. Clinical stage T3 or T4

7. Liver metastases

Key Inclusion Criteria for Treatment Study:

1. Advanced disease, histologically assessed as RCC, with a component of clear cell
histology

2. Measurable metastatic disease that can be monitored throughout the course of the
study participation per RECIST 1.1 (refer to Appendix C)

3. Subjects who are candidates for a first-line therapy initiating with sunitinib

4. Time from diagnosis to treatment < 1 year

5. Karnofsky performance status (KPS) ≥ 80%

6. Life expectancy of 6 months or greater

7. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to
Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for
Adverse Events Version 4.0

8. Adequate hematologic, renal, hepatic, and coagulation function

9. Negative serum pregnancy test for female subjects with reproductive potential, and
agreement of all male and female subjects of reproductive potential to use a reliable
form of contraception during the study and for 12 weeks after the last dose of study
drug

10. Normal ECG or clinically non-significant finding(s) at Screening

11. Able to abstain from taking prohibited drugs, either prescription or
non-prescription, during the treatment phase of the study

12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures

Key Exclusion Criteria for Treatment Study:

1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC,
including immunotherapy, chemotherapy, hormonal, or investigational therapy

2. Prior history of malignancy other than RCC within the preceding 3 years, except for
adequately treated in situ carcinomas or non-melanoma skin cancer

3. History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or evidence of brain or leptomeningeal disease

4. Patients with 5 or more of the following risk factors:

1. Time from diagnosis to treatment <1 year

2. Hgb < LLN

3. Corrected calcium > 10.0 mg/dL

4. KPS < 80%

5. Neutrophils > ULN

6. Platelets > ULN

5. Planned or elective surgical treatment or radiation therapy post-nephrectomy within
28 days before Visit 1 (Day 0)

6. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)

7. Clinically significant cardiovascular conditions within 3 months prior to
Randomization

8. Significant gastrointestinal abnormalities

9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication

10. Active autoimmune disease or condition requiring chronic immunosuppressive therapy

11. Clinically significant infections, including human immunodeficiency virus, syphilis,
and active hepatitis B or C

12. Current treatment with an investigational therapy on another clinical trial

13. Pregnancy or breastfeeding

14. Any serious medical condition or illness considered by the investigator to constitute
an unwarranted high risk for investigational treatment