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.
- Added: April 26th, 2019.
- Last updated: April 26th, 2019.
Primary Outcome Measures
- 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
- 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.
- 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.
- 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).
Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: April 26th, 2019.
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