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

• Status: Withdrawn
• Trial end date: 2019-11-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed

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).