EUCTR2020-005990-29-BE进行中（未招募）1 期
An Early Phase Randomized Trial of APX005M in BRCAwt Patients with Recurrent Ovarian Cancer
ordic Society of Gynaecological Oncology - Clinical Trial Unit (NSGO-CTU)0 个研究点目标入组 90 人开始时间: 2021年10月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- 性别
- Female
入选标准
- •1. Have signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation.
- •2. Histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.
- •3. Radiological or histological confirmation of relapse disease = 6 month after last chemotherapy.
- •4. Known BRCAwt.
- •5. Have completed at least one line of platinum-containing chemotherapy (maximum 3 previous lines of therapy are permitted). Earlier PARPi and earlier bevacizumab therapies are permitted.
- •6. Must have measurable or evaluable disease according to RECIST 1.1.
- •7. Baseline biopsy: Tissue biopsy for submission to central laboratory prior to study treatment should be from a newly obtained metastatic biopsy, if there is a lesion suitable for biopsy and the subject consents to this procedure. If a metastatic biopsy is not feasible, or patient is unwilling to provide new biopsy, archival tissue samples should be submitted. Archival tissue sample from metastatic site is preferred; however, archival tissue sample of primary tumor is acceptable.
- •8. Must consent to undergo mandatory tumor biopsy of at least one metastatic site at day 84 (±7). Biopsy at day 84 (±7) is only applicable if surgery is not performed.
- •9. Age = 18 years.
- •10. Body weight > 30 kg.
- •11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •12. Must have a life expectancy = 12 weeks.
- •13. Must have normal Left Ventricular Ejection Fraction (LVEF > 50%) measured by MUGA scan or echocardiography.
- •14. Must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below (5% deviation for hematological parameters and 10% deviation for biochemistry is permitted):
- •a. Haemoglobin = 10.0 g/dL (= 6.2 mmol/L) with no blood transfusion in the past 28 days;
- •b. Absolute neutrophil count (ANC) = 1.5 x 10^9/L;
- •c. Platelet count = 100 x 10^9/L;
- •d. Total bilirubin = 1.5 x institutional upper limit of normal (ULN);
- •e. Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) /Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case, they must be = 5 x ULN.
- •15. Must have creatinine clearance estimated = 50 mL/min using the Cockcroft-Gault formula.
- •16. A participant is eligible to participate, if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- •- Is not a woman of childbearing potential (WOCBP) OR
- •- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 of the protocol during the intervention period and for at least 90 days after the last dose of APX005M and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) prior to the first dose of study intervention.
- •- A WOCBP must have a negative urine or serum pregnancy test within 28 days of study treatment and a confirmed negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention.
排除标准
- •1. Previous immunotherapy (for example anti-PD-1/L1).2. Other malignancy unless curatively treated with no evidence of disease for = 3years,except adequately treated non-melanoma skin cancer,curatively treated in situ cancer of the cervix,ductal carcinoma in situ (DCIS) and stage 1 grade 1 endometrial carcinoma.3. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia,uncontrolled symptomatic arrhythmia,congestive heart failure,QTcF prolongation >500 ms,electrolyte disturbances, etc.),or subjects with congenital long QT syndrome.4. Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.5. Subjects with symptomatic uncontrolled brain metastases.A scan to confirm the absence of brain metastases is not required.Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.6. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.Subjects who have received acute,low-dose,systemic immunosuppressant medications (e.g.,a one-time dose of dexamethasone for nausea) or physiologic replacement doses (i.e. prednisone 5 - 7.5 mg/day) for adrenal insufficiency may be enrolled in the study.Inhaled or topical steroids,and adrenal replacement steroid doses = 10 mg daily prednisone equivalent,are permitted in the absence of active autoimmune disease.7. Prior radiation therapy.8. Planned concomitant therapy with any other anticancer therapy.9. Conditions requiring ongoing therapy with antibiotics.10. History of any arterial thromboembolic event within 3 months prior to first dose of APX005M.11. Active coagulopathy.12. Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation.13. History of organ transplant.14. Major surgery or significant traumatic injury within 4 weeks prior to first dose of study drugs.15. Pregnant or breastfeeding women.16. Subjects with a known hypersensitivity to any of the excipients of the product.17. Any unresolved toxicity NCI CTCAE Grade = 2 from previous anticancer therapy,except alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.a. Subjects with Grade = 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Lead Principal Investigator (PI) of the respective collaborative group.b. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with study drugs may be included only after consultation with the Lead PI of the respective collaborative group.18. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease,diverticulitis,systemic lupus erythematosus,Sarcoidosis syndrome,or Wegener syndrome.The following are exceptions to this criterion:
- •a. Subjects with vitiligo or alopecia.b. Subjects with hypothyroidism stable on hormone replacement.c. Any chronic skin condition that does not require systemic therapy.d. Subjects without active disease in the last 5 years may be included,but only after consultation with the Lead PI of the respective collaborative group.e. Subjects with celiac disease controlled by diet alone.19. Subjects considered a poor medical risk due to a serious,uncontrolled medical disorder,non-malignant
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