Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant

Tremelimumab was administered as an intravenous (IV) infusion over 60 ± 5 minutes at a fixed dose of 75 mg, regardless of weight.

"Durvalumab was administered as an IV infusion over 60 ± 5 minutes at a fixed dose of 1500 mg for subjects weighing \> 30 kg. If a subject's body weight dropped to ≤ 30 kg on study, the subject was dosed at 600 mg for as long as the body weight remained ≤ 30 kg.~When applicable, the durvalumab infusion was to start at least 60 minutes after the end of the tremelimumab infusion."

Prevnar-13 was administered as an intramuscular injection. The Prevnar-13 dose and the tremelimumab dose were to be separated by a minimum of 48 hours.

Melphalan was administered as an IV infusion according to institutional standard of care and local prescribing information.