INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105) (NCT03920839) | Clinical Trial Compass
WithdrawnPhase 1
INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
Stopped: As of November 4, 2019 the study was halted prematurely and will not resume.
0Started 2019-07-15
Plain-language summary
The purpose of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose of INCMGA00012 in combination with common standard-of-care chemotherapy regimens in participants with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Advanced and/or metastatic solid tumors including the following: histologically or cytologically confirmed diagnosis of Stage IIIB not amenable to curative treatment or Stage IV non-small cell lung cancer (pemetrexed-platinum treatment groups must have nonsquamous histology type); and histologically or cytologically confirmed diagnosis of advanced/metastatic unresectable malignant pleural mesothelioma.
* No prior systemic treatment with the following exceptions: participants with a known sensitizing mutation (eg, BRAF, EGFR, ALK, or ROS1) should have had disease progression on or following an approved targeted tyrosine kinase inhibitor; and participants who received adjuvant or neoadjuvant chemotherapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months before the date of enrollment.
* Measurable or nonmeasurable tumor lesions per RECIST v1.1.
* Eastern Cooperative Oncology Group performance status 0 to 1.
Exclusion Criteria:
* Received prior treatment with checkpoint inhibitor agents (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4).
* Had major surgery within 3 weeks before the first dose of study treatment.
* Received radiation therapy to the lung(s) that is \> 30 Gy within 6 months of the first dose of study treatment.
* Received palliative radiotherapy within 7 days before the first dose of study treatment.
* Has ≥ Grade 2 residual toxicities from the most recent prior therapy (except alopecia).
* Organ func…
What they're measuring
1
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy