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Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

Estimated reading time: 1 min

Condition

Advanced Malignancies|Metastatic Malignancies

Estimated Enrollment: 450

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment

Study ID Numbers: INCAGN 1876-201

Study First Received: April 19, 2017

Last Updated: April 21, 2017

Estimated Primary Completion Date: January 2020

Primary Outcome Measures:

Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)|Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST v1.1)|Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST v1.1|Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST v1.1|Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST v1.1|Phase 1 & Phase 2: Overall survival|Phase 1 & Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events

Sponsors and Collaborators:

Incyte Corporation

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT03126110

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