Figlin 2014

Trial name or title	ADAPT: an International Phase 3 Randomised Trial of Autologous Dendritic Cell Immunotherapy (AGS‐003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (NCT01582672).
Methods	Study design: 2‐arm, parallel‐group, open‐label RCT. Setting: multicentre, international, phase III. Countries: Canada, Czech Republic, Hungary, Israel, Italy, Spain, UK, US.
Participants	Main inclusion criteria: aged ≥ 18 years; either gender; histological confirmation of advanced RCC with predominantly clear‐cell histology; advanced disease; metastatic disease (measurable or non‐measurable per RECIST 1.1); people who were candidates for standard first‐line therapy initiating with sunitinib; time from diagnosis to treatment < 1 year; KPS ≥ 70%; life expectancy ≥ 6 months; resolution of all acute toxic effects of prior radiotherapy or surgical procedures to grade ≤ 1 (NCI‐CTC 4.0); adequate haematological, renal, hepatic and coagulation function; negative serum pregnancy test for women with reproductive potential and agreement of both men and women of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug. Main exclusion criteria: prior systemic therapy of any type for RCC, including immunotherapy, chemotherapy, hormonal or investigational therapy; prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non‐melanoma skin cancer; adequately treated early‐stage breast cancer, superficial bladder cancer and non‐metastatic prostate cancer with a normal PSA; history of, or known, brain metastases; spinal cord compression, carcinomatous meningitis or evidence of brain or leptomeningeal disease; people with ≥ 4 of the following risk factors: haemoglobin < LLN, corrected calcium > 10 mg/dL, KPS < 80%, neutrophils > ULN, platelets > ULN, planned or elective surgical treatment postnephrectomy for the direct management of RCC, within 28 days before visit 1, NCI CTCAE grade 3 haemorrhage < 28 days before day 0, clinically significant comorbidities. Sample size planned:450.
Interventions	Group 1: AGS‐003 + standard treatment (sunitinib). Group 0: standard treatment (sunitinib).
Outcomes	Primary outcome: OS, duration from randomization to death. Secondary outcomes: PFS, tumour response, AEs.
Starting date	November 2012.
Contact information	Robert Figlin, MD, principal Investigator.
Notes	Final data collection date for primary outcome measure: April 2017.