Clinical trial NCT03920839: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: 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
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
timeFrame: Up to approximately 27 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through study completion, up to approximately 31 months
measure: Duration of response (DOR)
timeFrame: Through study completion, up to approximately 31 months
measure: Disease control rate (DCR)
timeFrame: Through study completion, up to approximately 31 months
measure: Cmax of INCMGA00012 when given in combination with chemotherapy agents
timeFrame: Through post-induction Cycle 5 Day 1, up to 15 weeks
measure: Tmax of INCMGA00012 when given in combination with chemotherapy agents
timeFrame: Through post-induction Cycle 5 Day 1, up to 15 weeks
measure: Cmin of INCMGA00012 when given in combination with chemotherapy agents
timeFrame: Through post-induction Cycle 5 Day 1, up to 15 weeks
measure: AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
timeFrame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: