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

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ClinicalTrials.gov Identifier: NCT03920839
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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: INCMGA00012 Drug: Gemcitabine Drug: Cisplatin Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 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)
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INCMGA00012 + gemcitabine/cisplatin Drug: INCMGA00012
INCMGA00012 administered intravenously at a starting dose of 375 mg every 3 weeks, with dose de-escalation to 250 mg every 3 weeks if protocol-defined dose-limiting toxicity criteria are met.

Drug: Gemcitabine
Gemcitabine 1250 mg/m^2 administered intravenously on Days 1 and 8 of 21-day cycles.

Drug: Cisplatin
Cisplatin 75 mg/m^2 administered intravenously on Day 1 of 21-day cycles.

Experimental: INCMGA00012 + pemetrexed/cisplatin Drug: INCMGA00012
INCMGA00012 administered intravenously at a starting dose of 375 mg every 3 weeks, with dose de-escalation to 250 mg every 3 weeks if protocol-defined dose-limiting toxicity criteria are met.

Drug: Cisplatin
Cisplatin 75 mg/m^2 administered intravenously on Day 1 of 21-day cycles.

Drug: Pemetrexed
Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 21-day cycles.

Experimental: INCMGA00012 + pemetrexed/carboplatin Drug: INCMGA00012
INCMGA00012 administered intravenously at a starting dose of 375 mg every 3 weeks, with dose de-escalation to 250 mg every 3 weeks if protocol-defined dose-limiting toxicity criteria are met.

Drug: Pemetrexed
Pemetrexed 500 mg/m^2 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: INCMGA00012
INCMGA00012 administered intravenously at a starting dose of 375 mg every 3 weeks, with dose de-escalation to 250 mg every 3 weeks if protocol-defined dose-limiting toxicity criteria are met.

Drug: Carboplatin
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.

Drug: Paclitaxel
Paclitaxel 200 mg/m^2 administered intravenously on Day 1 of 21-day cycles.




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.



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920839


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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United States, California
California Cancer Associates for Research and Excellence Not yet recruiting
San Diego, California, United States, 92127
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Nawel Bourayou, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03920839     History of Changes
Other Study ID Numbers: INCMGA 0012-105
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
solid tumors
non-small cell lung cancer
malignant pleural mesothelioma
chemotherapy
programmed cell death protein 1 (PD-1) inhibitor

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Mesothelioma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents