A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
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|ClinicalTrials.gov Identifier: NCT03679767|
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non-small Cell Lung Cancer Locally Advanced Urothelial Cancer Metastatic Urothelial Cancer Unresectable Melanoma Metastatic Melanoma Locally Advanced Renal Cell Carcinoma Metastatic Clear-Cell Renal Cell Carcinoma||Drug: INCMGA00012||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||April 2021|
INCMGA00012 administered to cohorts of specific tumor types.
INCMGA00012 administered intravenously at the recommended Phase 2 dose every 4 weeks.
- Overall response rate [ Time Frame: Up to at least 6 months from the start of treatment ]Defined as the percentage of participants having a complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.
- Duration of response [ Time Frame: Up to approximately 3 years ]Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until first observation of documented disease progression as determined by investigator or death due to any cause.
- Disease control rate [ Time Frame: Up to approximately 3 years ]Defined as the proportion of participants with either an objective response (CR and PR) or stable disease, according to RECIST v1.1.
- Progression-free survival [ Time Frame: Up to approximately 3 years ]Defined as the time from the start of therapy until disease progression, as determined by investigator or death due to any cause.
- Overall survival [ Time Frame: Up to approximately 3 years ]Defined as the time from the start of therapy until death due to any cause.
- Number of treatment-emergent adverse events [ Time Frame: Up to approximately 3 years ]Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Cmax of INCMGA00012 [ Time Frame: Up to approximately 2 years ]Maximum observed plasma or serum concentration.
- Tmax of INCMGA00012 [ Time Frame: Up to approximately 2 years ]Time to maximum concentration.
- Cmin of INCMGA00012 [ Time Frame: Up to approximately 2 years ]Minimum observed plasma or serum concentration over the dose interval.
- AUC0-t of INCMGA00012 [ Time Frame: Up to approximately 2 years ]Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679767
|Contact: Incyte Corporation Call Center (US)||email@example.com|
|Contact: Incyte Corporation Call Center (ex-US)||+800 firstname.lastname@example.org|
|United States, Texas|
|Coastal Bend Oncology||Recruiting|
|Corpus Christi, Texas, United States, 78404|
|AIM Trials, LLC||Recruiting|
|Plano, Texas, United States, 75093|
|Study Director:||Mark Cornfeld, MD||Incyte Corporation|