NCT02089685

Trial name or title	KEYNOTE 029 ‐ a Phase I/II Clinical Trial to Study the Safety and Tolerability of MK‐3475 + Pegylated Interferon Alfa‐2b (PEG‐IFN) and MK‐3475 + Ipilimumab (IPI) in Subjects with Advanced Melanoma (MEL) and Renal Cell Carcinoma (RCC).
Methods	Study design: 3‐arm, parallel‐group, open‐label RCT. Setting: multicentre, international. Countries: Australia, New Zealand, US.
Participants	Inclusion criteria: aged ≥ 18 years, either gender, people with histologically confirmed advanced or metastatic melanoma or RCC, RCC participants must have received ≥ 1 prior line of therapy for metastatic disease, ECOG Performance Status of 0 or 1, adequate organ function. Exclusion criteria: cerebral metastases, diagnosis of immunodeficiency or receiving systemic steroid therapy, additional malignancy, active infection requiring systemic therapy, pregnancy, breastfeeding women. Sample size planned:343.
Interventions	Group 1: pembrolizumab + PegIFN‐2b. Group 1.1: pembrolizumab + ipilimumab. Group 0: pembrolizumab.
Outcomes	Primary outcome: dose‐limiting toxicities, AE, PFS. Secondary outcomes: ORR, OS.
Starting date	March 2014.
Contact information	Sponsor: Merck Sharp & Dohme Corp.
Notes	Estimated primary completion date: April 2017.