4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

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.

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 Design
Layout table for study information
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
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Through study completion, up to approximately 31 months ]
    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.

  2. Duration of response (DOR) [ Time Frame: Through study completion, up to approximately 31 months ]
    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.

  3. Disease control rate (DCR) [ Time Frame: Through study completion, up to approximately 31 months ]
    Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.

  4. Cmax of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Maximum observed plasma or serum concentration.

  5. Tmax of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Time to maximum concentration.

  6. Cmin of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Minimum observed plasma or serum concentration over the dose interval.

  7. AUC0-t of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Sponsors and Collaborators
Incyte Corporation
Investigators
Layout table for investigator information
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
 (submitted: April 17, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Objective response rate (ORR) [ Time Frame: Through study completion, up to approximately 31 months ]
    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) [ Time Frame: Through study completion, up to approximately 31 months ]
    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) [ Time Frame: Through study completion, up to approximately 31 months ]
    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 [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Maximum observed plasma or serum concentration.
  • Tmax of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Time to maximum concentration.
  • Cmin of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Minimum observed plasma or serum concentration over the dose interval.
  • AUC0-t of INCMGA00012 when given in combination with chemotherapy agents [ Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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.
  • 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.
  • Drug: Paclitaxel
    Paclitaxel administered intravenously on Day 1 of 21-day cycles.
Study Arms  ICMJE
  • Experimental: INCMGA00012 + gemcitabine/cisplatin
    Interventions:
    • Drug: Retifanlimab
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • Experimental: INCMGA00012 + pemetrexed/cisplatin
    Interventions:
    • Drug: Retifanlimab
    • Drug: Cisplatin
    • Drug: Pemetrexed
  • Experimental: INCMGA00012 + pemetrexed/carboplatin
    Interventions:
    • Drug: Retifanlimab
    • Drug: Pemetrexed
    • Drug: Carboplatin
  • Experimental: INCMGA00012 + paclitaxel/carboplatin
    Interventions:
    • Drug: Retifanlimab
    • Drug: Carboplatin
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 11, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
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:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Incyte Medical Monitor Incyte Corporation
PRS Account Incyte Corporation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院