A Phase 1 Study to Evaluate MEDI4736

This phase 1 research study aims to treat advanced malignant melanoma using MEDI4736 treatments.

NCTId: NCT01693562

Study Interventions & Types

Drug Intervention(s)

MEDI4736 - MEDI4736 will be administered by IV infusion every 14 or 21 days.


Study Outcomes

Primary Outcome(s)

Timeframe: Until end of study
Measure: Anti-tumor efficacy (dose expansion subjects)
Description: Evaluate the objective response rate in subjects with non-squamous NSCLC who have received 2 or more prior lines of therapy and subjects with squamous NSCLC who have received 1 prior lines of therapy and 2 or more prior lines of therapy
Safety Issue? No

Timeframe: 90 days after the last dose of MEDI4736
Measure: Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs).
Description: MTD or OBD will be determined by the number of participants experiencing dose-limiting toxicities. Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations.
Safety Issue? Yes

Secondary Outcome(s)

Measure: Area under the concentration time curve, maximum concentration, clearance, half-life after administration of MEDI4736.
Timeframe: Up to 90 days after the last dose of MEDI4736
Description: If data allow, noncompartmental PK parameters (AUC, Cmax, CL, t½) will be estimated.
Safety Issue? No

Measure: Disease control rate (DCR)
Timeframe: Until end of study
Description: The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥ 12 weeks)
Safety Issue? No

Measure: Duration of response (DR)
Timeframe: Until end of study
Description: Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Safety Issue? No

Measure: Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Timeframe: Up to 6 months after the last dose of MEDI4736.
Description: The immunogenic potential of MEDI4736 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Safety Issue? Yes

Measure: Objective response rate (ORR)
Timeframe: Until end of study
Description: The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Safety Issue? No

Measure: Overall survival (OS)
Timeframe: From first dose of study drug until death or up to 2 years
Description: Overall survival will be determined as the time from the start of treatment with MEDI4736 until death.
Safety Issue? No

Measure: Progression-free survival (PFS)
Timeframe: Until end of study
Description: Progression-free survival is the time interval from the start of treatment with MEDI4736 until the documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
Safety Issue? No