NCT03920839撤回1 期
A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Eastern Cooperative Oncology Group performance status 0 to 1.
排除标准
- •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
- •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).
研究组 & 干预措施
INCMGA00012 + gemcitabine/cisplatin
Experimental
干预措施: Retifanlimab (Drug)
INCMGA00012 + gemcitabine/cisplatin
Experimental
干预措施: Gemcitabine (Drug)
INCMGA00012 + gemcitabine/cisplatin
Experimental
干预措施: Cisplatin (Drug)
INCMGA00012 + pemetrexed/cisplatin
Experimental
干预措施: Retifanlimab (Drug)
INCMGA00012 + pemetrexed/cisplatin
Experimental
干预措施: Cisplatin (Drug)
INCMGA00012 + pemetrexed/cisplatin
Experimental
干预措施: Pemetrexed (Drug)
INCMGA00012 + pemetrexed/carboplatin
Experimental
干预措施: Retifanlimab (Drug)
INCMGA00012 + pemetrexed/carboplatin
Experimental
干预措施: Pemetrexed (Drug)
INCMGA00012 + pemetrexed/carboplatin
Experimental
干预措施: Carboplatin (Drug)
INCMGA00012 + paclitaxel/carboplatin
Experimental
干预措施: Retifanlimab (Drug)
INCMGA00012 + paclitaxel/carboplatin
Experimental
干预措施: Carboplatin (Drug)
INCMGA00012 + paclitaxel/carboplatin
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
时间窗: 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.
次要结局
- Duration of response (DOR)(Through study completion, up to approximately 31 months)
- Cmax of INCMGA00012 when given in combination with chemotherapy agents(Through post-induction Cycle 5 Day 1, up to 15 weeks)
- Tmax of INCMGA00012 when given in combination with chemotherapy agents(Through post-induction Cycle 5 Day 1, up to 15 weeks)
- Objective response rate (ORR)(Through study completion, up to approximately 31 months)
- Disease control rate (DCR)(Through study completion, up to approximately 31 months)
- Cmin of INCMGA00012 when given in combination with chemotherapy agents(Through post-induction Cycle 5 Day 1, up to 15 weeks)
- AUC0-t of INCMGA00012 when given in combination with chemotherapy agents(Through post-induction Cycle 5 Day 1, up to 15 weeks)
研究者
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