Advanced and/or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
| Verified date | April 2020 |
| Source | Incyte Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 4, 2019 |
| Est. primary completion date | November 4, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Incyte Corporation |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to approximately 27 months | |
| Secondary | 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. | Through study completion, up to approximately 31 months | |
| Secondary | 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. | Through study completion, up to approximately 31 months | |
| Secondary | 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. | Through study completion, up to approximately 31 months | |
| Secondary | Cmax of INCMGA00012 when given in combination with chemotherapy agents | Maximum observed plasma or serum concentration. | Through post-induction Cycle 5 Day 1, up to 15 weeks | |
| Secondary | Tmax of INCMGA00012 when given in combination with chemotherapy agents | Time to maximum concentration. | Through post-induction Cycle 5 Day 1, up to 15 weeks | |
| Secondary | Cmin of INCMGA00012 when given in combination with chemotherapy agents | Minimum observed plasma or serum concentration over the dose interval. | Through post-induction Cycle 5 Day 1, up to 15 weeks | |
| Secondary | 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. | Through post-induction Cycle 5 Day 1, up to 15 weeks |