EUCTR2016-001359-36-ES进行中（未招募）1 期
A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 815
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Signed Written Informed Consent
- •2) Target Population
- •a) Subjects must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
- •b) Presence of at least 1 lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment. Subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately. As of Protocol
- •Amendment 13, subjects undergoing biopsy do not need to have a biopsy lesion that is distinct from an index lesion.
- •c) Subjects must consent to allow the acquisition of existing FFPE material tissue block or tumor tissue sections for performance of correlative studies.
- •d) A minimum of 10 subjects each in the MEL cohort and the SCCHN cohort (the Dose Escalation and Cohort Expansion [Part 1; completed]) will be required to undergo mandatory pre-treatment and on-treatment biopsies in the cohort expansion phase at acceptable clinical risk as judged by the investigator. All other subjects will have the
- •option of undergoing pre-treatment, on-treatment, and post-treatment biopsies
- •e) The first dose of study drug must be at least 28 days from the last dose of prior therapy.
- •f) ECOG status of 0 or 1.
- •g) Life expectancy of = 12 weeks.
- •h) Adequate organ function for all subjects except those with HCC: see protocol
- •i) Adequate organ function for all HCC subjects: see protocol
- •j) Ability to comply with treatment, PK and pharmacodynamics sample collection and required study follow-up.
- •k) Subject re-enrollment: this study permits the re-enrollment of a subject who has discontinued the study as a pre-treatment failure (ie, subject has not been randomized/has not been treated). If re-enrolled, the subject must be re-consented.
- •l) Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- •m) Subjects must have resting baseline oxygen saturation measured by pulse oximetry of = 92% at rest on room air.
- •3) Age, Sex, and Reproductive Status
- •a) Men and women, ages = 18 years.
- •b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug.
- •c) Women must not be breastfeeding.
- •d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 5 months after the last dose of study drug (ie, 30 days [duration of ovulatory cycle] plus the time required for the study drug to undergo approximately 5 half-lives.)
- •e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study drug (ie, 90 days [duration of sperm turnover] plus the time required for the study drug to undergo approximately 5 half-lives.)
- •f) Azoospermic ma
排除标准
- •1) Target Disease Exceptions
- •a) Subjects with untreated CNS metastases
- •b) Participation in any prior study with ipilimumab/nivolumab, incl in comparator arms
- •c) SCCHN subjects only: Histologically confirmed recurrent/metastatic carcinoma of nasopharynx, and the skin and salivary gland/on-squamous histologies are not allowed
- •d) Subjects with carcinomatous meningitis
- •2) Medical History and Concurrent Diseases
- •a) Subjects with previous malignancies (except non-MEL skin cancers, and the following cancers: bladder, gastric, colon, esophageal endometrial, cervical/dysplasia, MEL, or breast) unless a complete remission was achieved at least 2 years prior to study entry + no additional therapy is required during the study period
- •b) Subjects with an active/known or suspected autoimmune disease
- •c) A known/underlying condition that, could make the administration of study drug hazardous, or could adversely affect the ability to comply with or tolerate drug. N/A from Prot Amdt 13 and next Amdts
- •d) Uncontrolled/significant cardiovascular disease
- •e) Known history of positive test for human immunodeficiency virus (HIV)/known acquired immunodeficiency syndrome. No HIV testing is required during screening. NOTE: Testing for HIV must be performed at study sites where mandated locally
- •i) Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. N/A from Prot Amdt 13 and next Amdts
- •ii) Subjects with a history of resolved hepatitis A virus infection are eligible. N/A from Prot 13 and next Amdts
- •f) Evidence of active infection = 7 days prior to initiation of study drug therapy. N/A from Prot Amdt 13 and next Amdts
- •g) Any serious/uncontrolled medical disorders
- •h) Any major surgery within 4 weeks of study drug administration
- •i) Subjects who are unable to undergo venipuncture and/or to tolerate venous access. N/A from Prot Amdt 13 and next Amdts
- •j) Any other sound medical, psychiatric and/or social reason determined by the investigator. N/A from Prot Amdt 13 and next Amdts
- •k) All toxicities attributed to systemic prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 or baseline before administration of study drug.
- •3) Prohibited Prior Treatments and/or Therapies
- •a) Prior treatment with an anti-KIR antibody/anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways except as noted below
- •b) Prior treatment regimens with any immune cell modulating antibody (anti-CD137 and anti-OX40). But, prior anti-CTLA-4 therapy is allowed if last dose is 101 days or more from the first dose. N/A from Prot Amdt 13 and next Amdts
- •c) Exposure to any other investigational drug within 4 weeks prior to the first dose
- •d) Treatment with any anti-cancer therapy, chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration
- •e) Prior focal palliative radiotherapy within 2 weeks prior to the first dose of study administration
- •f) Use of non-oncology v
研究者
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