CTRI/2020/02/023441尚未招募3 期
Phase 3 non inferiority randomised study between low dose immunotherapy and cytotoxicchemotherapy in 2nd line or beyond setting in relapsed-recurrent or metastatic solid tumors - DELII
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
入选标准
- •1. Subjects must have recurrent-relapsed or progressed solid tumor cancer after at least one line of systemic treatment, and are planned for palliative intent systemic therapy ( In case of failure within 6 months of administration of curative treatment, the chemotherapy received during this treatment will be considered as ï¬?rst line). Sites (These are the sites were nivolumab is the standard of care treatment) applicable are Lung cancer1. Head and neck cancer
- •2. Urothelial cancer
- •3. Triple negative breast cancer
- •4. Esophageal cancer
- •5. Any solid tumor with microsatellite instability-high (MSI-H) or mismatch repair deï¬?cient (dMMR) status
- •6. 2. Age: Male or female subjects aged >= 18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- •4. Subjects must have normal organ and marrow function as deï¬?ned below: a. Hematologic: Absolute neutrophil count (ANC) >= 1.5 Ã? 109/L, platelet count >= 100 Ã? 109/L, and hemoglobin >= 8 g/dL (may have been transfused). b. Hepatic: Total bilirubin level <= 1.5 Ã? the upper limit of normal (ULN) range and AST and ALT levels <= 2.5 Ã? ULN or AST and ALT levels <= 5 x ULN (for subjects with documented metastatic disease to the liver). c. Renal: Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula.
- •5. Presence of at least one measurable lesion as deï¬?ned by RECIST version 1.1.
- •6. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active anti-retroviral therapy), and have absence of active AIDS deï¬?ning conditions.
- •7. Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential.
- •8. Contraception: Highly eï¬?ective contraception for both male and female subjects throughout the study and for at least 30 days after last Nivolumab treatment administration if the risk of conception exists. The eï¬?ects of Nivolumab on the developing human fetus are teratogenic. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •9. Both men and women of all races and ethnic groups are eligible for this study.
- •10. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.
- •11. Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Subjects who are receiving any other investigational agents.
- •2. Within 3 weeks of administration of chemotherapeutic agent.
- •3. IMMUNOSUPPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses <= 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis.
- •4. AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- •5. ORGAN TRANSPLANTATION: Prior organ transplantation including allogeneic stem-cell transplantation.
- •6. INFECTIONS: Active infection requiring systemic therapy.
- •7. HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
- •8. VACCINATION: Vaccination within 4 weeks of the ï¬?rst dose of Nivolumab and while on study is prohibited except for administration of inactivated vaccines.
- •9. HYPERSENSITIVITY TO STUDY DRUG: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade >= 3).
- •10. CARDIOVASCULAR DISEASE: Clinically signiï¬?cant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke ( < 6 months prior to enrollment), myocardial infarction ( < 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classiï¬?cation Class II), or serious cardiac arrhythmia requiring medication.
- •11. OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI-CTCAE v4.03 Grade > 1); however, alopecia, sensory neuropathy Grade <= 2, or other Grade <= 2 not constituting a safety risk based on Investigatorâ??s judgment is acceptable.
- •12. Other severe acute or chronic medical conditions including immune colitis, inï¬?ammatory bowel disease, immune pneumonitis, pulmonary ï¬?brosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
- •13. Pregnant women are excluded from this study. Based on its mechanism of action. Nivolumab can cause foetal harm when administered to a pregnant woman. Therefore, potential risks of administering Nivolumab during pregnancy include increased rates of abortion or stillbirth. Advise females of reproductive potential to use eï¬?ective contraception during treatment and for at least one month after the last dose of Nivolumab.
- •14. Lactating females: There is no information regarding the presence of Nivolumab in human milk, the eï¬?ects on the breastfed infant, or the eï¬?ects o
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