Primary Outcome Measures
Percentage of subjects with dose limiting toxicities (DLTs) with mRNA-2416 alone [Time Frame: Days 1-28] [Designated as safety issue: ]
Percentage of subjects with dose limiting toxicities (DLTs) with mRNA-2416 in combination with durvalumab [Time Frame: Days 1-28] [Designated as safety issue: ]
Percentage of subjects with adverse events (AEs) for mRNA-2416 alone [Time Frame: Baseline through 3 months after the last dose of study treatment] [Designated as safety issue: ]
Percentage of subjects with adverse events (AEs) for mRNA-2416 in combination with durvalumab [Time Frame: Baseline through 3 months after the last dose of study treatment] [Designated as safety issue: ]
In Phase II dose expansion: objective response rate (ORR) of mRNA-2416 alone and in combination with durvalumab in patients with ovarian cancer based on RECIST v1.1 [Time Frame: Baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first] [Designated as safety issue: ]
Secondary Outcome Measures
Percentage of subjects with anti-OX40L antibodies [Time Frame: Pre-dose through 14 days after last dose of study treatment] [Designated as safety issue: ]
Maximum Observed Serum Concentration (Cmax) of mRNA-2416 [Time Frame: Pre-dose through 29 days after initial mRNA-2416 dose] [Designated as safety issue: ]
Maximum Observed Serum Concentration (Cmax) of mRNA-2416 alone [Time Frame: Pre-dose through 29 days after initial dose of study treatment] [Designated as safety issue: ]
Area under the serum concentration-time curve (AUC) of mRNA-2416 alone [Time Frame: Pre-dose through 29 days after initial dose of study treatment] [Designated as safety issue: ]
Area under the serum concentration-time curve (AUC) of mRNA-2416 in combination with durvalumab [Time Frame: Pre-dose through 29 days after initial dose of study treatment] [Designated as safety issue: ]
In Phase I only: ORR based on RECIST v1.1 or Cheson 2014 criteria (lymphomas) [Time Frame: Baseline through 6 months after last mRNA-2416 monotherapy dose] [Designated as safety issue: ]
In Phase I only: duration of response based on RECIST v1.1 or Cheson 2014 criteria (lymphomas) [Time Frame: Baseline through 6 months after last mRNA-2416 monotherapy dose] [Designated as safety issue: ]
In Phase I only: progression-free survival based on RECIST v1.1 or Cheson 2014 criteria (lymphomas) [Time Frame: Baseline through 6 months after last mRNA-2416 monotherapy dose] [Designated as safety issue: ]
Disease control rate in patients with ovarian cancer (RECIST v1.1) [Time Frame: Baseline through 6 months after last mRNA-2416 dose] [Designated as safety issue: ]
In Phase II: disease control rate in patients with ovarian cancer (RECIST v1.1) [Time Frame: Baseline through 6 months after last dose of study treatment] [Designated as safety issue: ]
In Phase II: duration of response in patients with ovarian cancer (RECIST v1.1) [Time Frame: Baseline through 6 months after last dose of study treatment] [Designated as safety issue: ]