NL-OMON44145撤回不适用
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB* (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES - B9991004
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological or cytological diagnosis of advanced/metastatic solid tumor with the following tumor types. Combinatie A: For Phase 1b,
- •patients with NSCLC that have progressed on standard therapy or for which no standard
- •therapy is available, and for Phase 2, patients with NSCLC, melanoma, SCCHN, and TNBC in any line of therapy.
- •NSCLC patients in Phase 2 with tumor anaplastic lymphoma kinase (ALK)
- •translocations or epidermal growth factor receptor (EGFR) mutations
- •must have received or been refractory/intolerant to standard therapy.
- •Patients with a history of PD-1 or PD-L1 refractory disease (best
- •response of PD) will not be eligible.
- •Combination B:
- •For phase 1b, patients with advanced solid tumors that have progressed
- •on standard therapy or for which no standard therapy is available. For
- •Phase 2, patients with NSCLC, melanoma, or SCCHN in any line of
- •therapy, or locally advanced/metastatic CRC that has progressed after at
- •least 1 line of standard therapy. NSCLC patients in Phase 2 with tumor
- •ALK translocations or EGFR mutations must have received or been
- •refractory / intolerant to standard therapy. Measurable disease by
- •RECIST v1.1 with at least 1 measureable lesion that has not
- •previously been irradiated.Availability of tumor specimens: For Phase 1b: Archival formalin-fixed
- •paraffin-embedded (FFPE) tissue is required if available. For Phase 2:
- •FFPE tissue must be available from the most recent primary or
- •metastatic tumor biopsy or resection prior to start of study therapy,
- •taken within 1 year prior to study entry, with no intervening systemic
- •anti-cancer therapy. This tissue may be prepared from a de novo biopsy
- •obtained prior to study entry. Core needle or excision biopsies are
- •Human papilloma virus (HPV) status based on locally approved testing
- •for patients with SCCHN, and microsatellite instability (MSI) status
- •based on locally approved testing for patients with CRC.
- •2. Age >=18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- •4. Estimated life expectancy of at least 3 months.
- •5. Adequate Bone Marrow Function, defined as:
- •a. Absolute Neutrophil Count (ANC) >=1.5 x 109/L ( >=1,500/µl);
- •b. Platelets >=100 x 109/L (>=100,000/ µl);
- •c. Hemoglobin >=9 g/dL (>5.6 mmol/L).
- •Patients must be transfusion independent (ie, no blood product transfusions for a period
- •of at least 14 days prior to study entry).
- •6. Adequate Renal Function, including estimated creatinine clearance >=50 mL/min as
- •calculated using the Cockcroft-Gault (CG) equation.
- •7. Adequate Liver Function, including:
- •a. Total serum bilirubin <=1.5 x upper limit of normal (ULN);
- •b. Aspartate and Alanine aminotransferase (AST & ALT) <=2.5 x ULN.
- •6. Resolved acute effects of any prior therapy to baseline severity or NCI
- •CTCAE v4.03 Grade <=1 (except alopecia and Grade <=2 sensory
- •neuropathy are acceptable).
- •9. Negative serum pregnancy test (for females of childbearing potential) at screening.
- •10. Male patients able to father children and female patients of childbearing potential and at
- •risk for pregnancy must agree to use two highly effective methods of contraception
- •throughout the study and for at least 60 days after the last dose of assigned treatment, as required by local regulations.
- •Female patients who are not of childbearing potential (ie
排除标准
- •1. Monoclonal antibody based anti-cancer therapy within 28 days prior to
- •study entry or small-molecule based anti-cancer therapy (targeted
- •therapy or chemotherapy) within 14 days prior to study entry.
- •2. Current or prior use of immunosuppressive medication within 7 days
- •prior to study entry The following are exceptions to this exclusion criterion: Intranasal,
- •inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); Systemic
- •corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
- •Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- •3. Active autoimmune disease that requires systemic steroids (equivalent of >10 mg
- •prednisone) or immunosuppressive agents within 7 days prior to study entry. Exceptions
- •include: patients with controlled diabetes type 1, controlled hypo- or hyperthyroidism,
- •resolved childhood asthma/atopy, vitiligo, or psoriasis not requiring immunosuppressive
- •4. Known prior or suspected hypersensitivity to investigational products or any component
- •in their formulations, including known severe hypersensitivity reactions to monoclonal
- •antibodies (NCI CTCAE v4.03 Grade >=3), and any history of anaphylaxis, or
- •uncontrolled asthma (ie, 3 or more features of partly controlled asthma).33
- •5. Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry.
- •Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been
- •completed 48 hours prior to study entry and there is at least one measurable lesion that
- •has not been irradiated.
- •6. Patients with known symptomatic brain metastases requiring steroids. Patients with
- •previously diagnosed brain metastases are eligible if they have completed their treatment
- •and have recovered from the acute effects of radiation therapy or surgery prior to study
- •entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks
- •prior to study entry, and are neurologically stable.
- •7. Previous high-dose chemotherapy requiring stem cell rescue.
- •8. Prior allogeneic stem cell transplant or organ graft.
- •9. Any of the following within the 6 months prior to study entry: myocardial infarction,
- •uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive
- •heart failure, cerebrovascular accident or transient ischemic attack.
- •10. Symptomatic pulmonary embolism within 6 months prior to study
- •11. Known HIV or AIDS-related illness
- •12. Active infection requiring systemic therapy
- •13. Positive HBV or HCV test indicating acute or chronic infection
- •14. Administration of a live vaccine within 4 weeks prior to study entry
- •15. Diagnosis of other malignancy within 5 years, except for adequately
- •treated basal cell or squamous cell skin cancer, or carcinoma in situ of
- •the breast or cervix, or low-grade (Gleason <=6) prostate cancer
- •16. Patients who are site staff members directly involved in the conduct
- •of the study and their family members, site staff members otherwise
- •supervised by the investigator, or patients who are Pfizer employees
- •directly involved in the conduct of the study
- •17. Participation in other studies involving investigational drug(s) within
- •4 weeks prior to study entry and/or during study participation
- •18. Persisting toxicity
研究者
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