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

NCT ID: NCT03920839

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2019-11-04

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCMGA00012 + gemcitabine/cisplatin

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

INCMGA00012 administered intravenously every 3 weeks.

Gemcitabine

Intervention Type: DRUG

Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.

Cisplatin

Intervention Type: DRUG

Cisplatin administered intravenously on Day 1 of 21-day cycles.

INCMGA00012 + pemetrexed/cisplatin

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

INCMGA00012 administered intravenously every 3 weeks.

Cisplatin

Intervention Type: DRUG

Cisplatin administered intravenously on Day 1 of 21-day cycles.

Pemetrexed

Intervention Type: DRUG

Pemetrexed administered intravenously on Day 1 of 21-day cycles.

INCMGA00012 + pemetrexed/carboplatin

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

INCMGA00012 administered intravenously every 3 weeks.

Pemetrexed

Intervention Type: DRUG

Pemetrexed administered intravenously on Day 1 of 21-day cycles.

Carboplatin

Intervention Type: DRUG

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

INCMGA00012 + paclitaxel/carboplatin

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

INCMGA00012 administered intravenously every 3 weeks.

Carboplatin

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

Paclitaxel administered intravenously on Day 1 of 21-day cycles.

Interventions

Retifanlimab

INCMGA00012 administered intravenously every 3 weeks.

Intervention Type: DRUG

Gemcitabine

Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.

Intervention Type: DRUG

Cisplatin

Cisplatin administered intravenously on Day 1 of 21-day cycles.

Intervention Type: DRUG

Pemetrexed

Pemetrexed administered intravenously on Day 1 of 21-day cycles.

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Paclitaxel

Paclitaxel administered intravenously on Day 1 of 21-day cycles.

Intervention Type: DRUG

Other Intervention Names

INCMGA00012

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Other Identifiers

INCMGA 0012-105

Identifier Type: -

Identifier Source: org_study_id