EUCTR2007-005666-12-HU
进行中（未招募）
1 期
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapy - IMA910
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- immatics biotechnologies GmbH
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Aged at least 18 years
- •HLA type: HLA\-A\*02\-positive
- •Histologically confirmed colorectal adenocarcinoma (CRC)
- •Radiological evidence (CT/MRI) of unresectable locally advanced and/or metastatic CRC prior to 12 week first\-line oxaliplatin\-based standard chemotherapy
- •12 week first\-line chemotherapy with an oxaliplatin\-based regimen according to an established standard protocol (e.g. FOLFOX or XELOX) administered at the following minimum dosages over this 12 week period: Oxaliplatin 400 mg/m2, Fluorouracil (5FU) 10\.000 mg/m2 or Capecitabine 84\.000 mg/m2 (a time window for application of first\-line chemotherapy of \+4 weeks is allowed)
- •Response (CR, PR) or stabilization (SD) following a 12 week first\-line oxaliplatin\-based standard chemotherapy shown by radiological evidence (CT/MRI after last cycle of first\-line oxaliplatin\-based standard chemotherapy compared to CT/MRI taken before start of first\-line oxaliplatin\-based standard chemotherapy)
- •Patients accept a chemotherapy\-free interval under close observation (CT or MRI scans performed every 9 weeks)
- •Maximum period between start of study treatment and start of the last cycle of standard chemotherapy (\= first day of last cycle of standard chemotherapy) is 42 days; minimum period is 18 days
- •Currently no other standard therapy indicated
- •Karnofsky Performance Status ?80%
排除标准
- •Any adjuvant systemic or local chemotherapy if ended ?6 months before start of systemic first\-line oxaliplatin\-based standard chemotherapy
- •Progressive disease during or at the end of 12 week systemic first\-line oxaliplatin based standard chemotherapy
- •CT/MRI scans taken more than 9 weeks before start of first\-line oxaliplatin\-based standard chemotherapy
- •Response to 12 week first\-line oxaliplatin\-based standard chemotherapy resulting in resectable disease; curative treatment intended
- •Immunosuppressive therapy within 10 days before first vaccination e.g. corticosteroid treatment (inhalative corticosteroids for e.g. asthma are allowed)
- •Radiotherapy during and/or following the 12 week first\-line oxaliplatin\-based standard chemotherapy (palliative radiotherapy for bone metastasis is allowed)
- •Concurrent or prior participation in a clinical trial applying interventional procedures (e.g. application of investigational drugs, surgical interventions) within the last 30 days
- •History of other malignant tumours within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
- •Presence of known brain metastasis on MRI or CT scans
- •Current partial or complete bowel obstruction
结局指标
主要结局
未指定
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An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyAdult HLA-A*02-positive patients who have been diagnosed with unresectable, locally advanced and/or metastatic colorectal cancer before first-line chemotherapy. Patients must have completed a 12 week first-line oxaliplatin-based standard chemotherapy (e.g. FOLFOX or XELOX) with either complete or partial response or stable disease as the outcome.EUCTR2007-005666-12-DEimmatics biotechnologies GmbH90
进行中（未招募）
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An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-LVimmatics biotechnologies GmbH9
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-BGimmatics biotechnologies GmbH90
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-BEimmatics biotechnologies GmbH90
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyAdult HLA-A*02-positive patients who have been diagnosed with unresectable, locally advanced and/or metastatic colorectal cancer before first-line chemotherapy. Patients must have completed a 12 week first-line oxaliplatin-based standard chemotherapy (e.g. FOLFOX or XELOX) with either complete or partial response or stable disease as the outcome.MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancerEUCTR2007-005666-12-GBimmatics biotechnologies GmbH70