| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced and/or Metastatic Solid Tumors Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma | Drug: Retifanlimab Drug: Gemcitabine Drug: Cisplatin Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105) |
| Actual Study Start Date : | July 15, 2019 |
| Actual Primary Completion Date : | November 4, 2019 |
| Actual Study Completion Date : | November 4, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: INCMGA00012 + gemcitabine/cisplatin |
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Name: INCMGA00012
Drug: Gemcitabine Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
Drug: Cisplatin Cisplatin administered intravenously on Day 1 of 21-day cycles.
|
| Experimental: INCMGA00012 + pemetrexed/cisplatin |
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Name: INCMGA00012
Drug: Cisplatin Cisplatin administered intravenously on Day 1 of 21-day cycles.
Drug: Pemetrexed Pemetrexed administered intravenously on Day 1 of 21-day cycles.
|
| Experimental: INCMGA00012 + pemetrexed/carboplatin |
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Name: INCMGA00012
Drug: Pemetrexed Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Drug: Carboplatin Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
|
| Experimental: INCMGA00012 + paclitaxel/carboplatin |
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Name: INCMGA00012
Drug: Carboplatin Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
Drug: Paclitaxel Paclitaxel administered intravenously on Day 1 of 21-day cycles.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Study Director: | Incyte Medical Monitor | Incyte Corporation |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 17, 2019 | ||||
| First Posted Date ICMJE | April 19, 2019 | ||||
| Last Update Posted Date | April 24, 2020 | ||||
| Actual Study Start Date ICMJE | July 15, 2019 | ||||
| Actual Primary Completion Date | November 4, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy [ Time Frame: Up to approximately 27 months ] Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105) | ||||
| Official Title ICMJE | A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105) | ||||
| Brief 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
96 | ||||
| Actual Study Completion Date ICMJE | November 4, 2019 | ||||
| Actual Primary Completion Date | November 4, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03920839 | ||||
| Other Study ID Numbers ICMJE | INCMGA 0012-105 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Incyte Corporation | ||||
| Study Sponsor ICMJE | Incyte Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Incyte Corporation | ||||
| Verification Date | April 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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