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As of November 4, 2019 the study was halted prematurely and will not resume.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCMGA00012 + gemcitabine/cisplatin | Experimental |
| |
| INCMGA00012 + pemetrexed/cisplatin | Experimental |
| |
| INCMGA00012 + pemetrexed/carboplatin | Experimental |
| |
| INCMGA00012 + paclitaxel/carboplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retifanlimab | Drug | INCMGA00012 administered intravenously every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy | Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment. | Up to approximately 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the percentage of participants having complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by investigator assessment. | Through study completion, up to approximately 31 months |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
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|
| Gemcitabine | Drug | Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles. |
|
| Cisplatin | Drug | Cisplatin administered intravenously on Day 1 of 21-day cycles. |
|
| Pemetrexed | Drug | Pemetrexed administered intravenously on Day 1 of 21-day cycles. |
|
| Carboplatin | Drug | Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles. |
|
| Paclitaxel | Drug | Paclitaxel administered intravenously on Day 1 of 21-day cycles. |
|
Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by investigator assessment or death due to any cause. |
| Through study completion, up to approximately 31 months |
| Disease control rate (DCR) | Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks. | Through study completion, up to approximately 31 months |
| Cmax of INCMGA00012 when given in combination with chemotherapy agents | Maximum observed plasma or serum concentration. | Through post-induction Cycle 5 Day 1, up to 15 weeks |
| Tmax of INCMGA00012 when given in combination with chemotherapy agents | Time to maximum concentration. | Through post-induction Cycle 5 Day 1, up to 15 weeks |
| Cmin of INCMGA00012 when given in combination with chemotherapy agents | Minimum observed plasma or serum concentration over the dose interval. | Through post-induction Cycle 5 Day 1, up to 15 weeks |
| AUC0-t of INCMGA00012 when given in combination with chemotherapy agents | Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. | Through post-induction Cycle 5 Day 1, up to 15 weeks |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000086002 | Mesothelioma, Malignant |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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