INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
Primary Purpose
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
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Retifanlimab
Gemcitabine
Cisplatin
Pemetrexed
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Advanced and/or Metastatic Solid Tumors focused on measuring solid tumors, non-small cell lung cancer, malignant pleural mesothelioma, chemotherapy, programmed cell death protein 1 (PD-1) inhibitor
Eligibility Criteria
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 function (renal, hepatic), bone marrow reserve, and coagulation panel outside the protocol-defined laboratory values.
- Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of study treatment.
- Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg once daily of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
- Is on chronic systemic steroids (> 10 mg once daily of prednisone or equivalent).
- Known active central nervous system metastases and/or carcinomatous meningitis (patients with previously-treated and clinically stable brain metastases are eligible and a washout period of ≥ 4 weeks since radiation therapy is required).
- Known additional malignancy that is progressing or requires active treatment.
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- History of organ transplant, including allogeneic stem cell transplantation.
- Active infections requiring systemic antibiotics.
- Known active hepatitis B or C.
- Has a diagnosis of immunodeficiency, including participants known to be HIV positive (positive for HIV 1/2 antibodies).
- Significant cardiac event within 6 months before Cycle 1 Day 1.
- Has received a live vaccine within 28 days of the planned start of study treatment.
- Known hypersensitivity to any component of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
INCMGA00012 + gemcitabine/cisplatin
INCMGA00012 + pemetrexed/cisplatin
INCMGA00012 + pemetrexed/carboplatin
INCMGA00012 + paclitaxel/carboplatin
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Duration of response (DOR)
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.
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.
Cmax of INCMGA00012 when given in combination with chemotherapy agents
Maximum observed plasma or serum concentration.
Tmax of INCMGA00012 when given in combination with chemotherapy agents
Time to maximum concentration.
Cmin of INCMGA00012 when given in combination with chemotherapy agents
Minimum observed plasma or serum concentration over the dose interval.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03920839
Brief Title
INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
Official Title
A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
As of November 4, 2019 the study was halted prematurely and will not resume.
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
solid tumors, non-small cell lung cancer, malignant pleural mesothelioma, chemotherapy, programmed cell death protein 1 (PD-1) inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCMGA00012 + gemcitabine/cisplatin
Arm Type
Experimental
Arm Title
INCMGA00012 + pemetrexed/cisplatin
Arm Type
Experimental
Arm Title
INCMGA00012 + pemetrexed/carboplatin
Arm Type
Experimental
Arm Title
INCMGA00012 + paclitaxel/carboplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
INCMGA00012
Intervention Description
INCMGA00012 administered intravenously every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin administered intravenously on Day 1 of 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel administered intravenously on Day 1 of 21-day cycles.
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
Description
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time Frame
Up to approximately 27 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
Through study completion, up to approximately 31 months
Title
Duration of response (DOR)
Description
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.
Time Frame
Through study completion, up to approximately 31 months
Title
Disease control rate (DCR)
Description
Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.
Time Frame
Through study completion, up to approximately 31 months
Title
Cmax of INCMGA00012 when given in combination with chemotherapy agents
Description
Maximum observed plasma or serum concentration.
Time Frame
Through post-induction Cycle 5 Day 1, up to 15 weeks
Title
Tmax of INCMGA00012 when given in combination with chemotherapy agents
Description
Time to maximum concentration.
Time Frame
Through post-induction Cycle 5 Day 1, up to 15 weeks
Title
Cmin of INCMGA00012 when given in combination with chemotherapy agents
Description
Minimum observed plasma or serum concentration over the dose interval.
Time Frame
Through post-induction Cycle 5 Day 1, up to 15 weeks
Title
AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
Description
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Time Frame
Through post-induction Cycle 5 Day 1, up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 function (renal, hepatic), bone marrow reserve, and coagulation panel outside the protocol-defined laboratory values.
Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of study treatment.
Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg once daily of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
Is on chronic systemic steroids (> 10 mg once daily of prednisone or equivalent).
Known active central nervous system metastases and/or carcinomatous meningitis (patients with previously-treated and clinically stable brain metastases are eligible and a washout period of ≥ 4 weeks since radiation therapy is required).
Known additional malignancy that is progressing or requires active treatment.
Evidence of interstitial lung disease or active, noninfectious pneumonitis.
History of organ transplant, including allogeneic stem cell transplantation.
Active infections requiring systemic antibiotics.
Known active hepatitis B or C.
Has a diagnosis of immunodeficiency, including participants known to be HIV positive (positive for HIV 1/2 antibodies).
Significant cardiac event within 6 months before Cycle 1 Day 1.
Has received a live vaccine within 28 days of the planned start of study treatment.
Known hypersensitivity to any component of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
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