EUCTR2018-002518-10-SE进行中（未招募）1 期
A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) in Participants with Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)
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
- 100
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
- 性别
- All
入选标准
- •1. Have histologically or cytologically confirmed melanoma
- •2. Have unresectable Stage III or Stage IV melanoma, per American Joint Committee on Cancer (AJCC) staging system version 8, not amenable to local therapy
- •3. Have the presence of at least 1 measurable lesion by CT or MRI per RECIST 1.1 as confirmed by BICR. Cutaneous lesions and other superficial lesions are not considered measurable lesions for the purposes of this protocol, but may be considered as non-target lesions
- •4. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
- •a. Received at least 2 doses of an anti-PD-1/L1 mAb
- •b. Has demonstrated disease progression after PD-1/L1 as defined by RECIST 1.1. The initial evidence of RECIST 1.1 disease progression is to be confirmed using iRECIST by a second assessment no less than 4 weeks from the date of the first documented progressive disease, in the absence of rapid clinical progression
- •c. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb
- •5. Have submitted initial imaging
- •6. Have an ECOG performance status 0 to 1
- •7. Have provided a baseline tumor biopsy
- •8. Have resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). If participant received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention
- •9. Be Male or Female and is at least 18 years of age at the time of providing the informed consent
- •10. Male participants are eligible to participate if they agree to the following during the intervention period andfor at least 95 days, corresponding to time needed to eliminate study interventions (eg, 5 terminal half-lives) after the last dose of study intervention:
- •- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- •- Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause [Appendix 5] as detailed below.
- •- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- •- Male participants must also agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.
- •11. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP)
- •b. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with lower user dependency, or be abstinent from heterosexual intercourse as their perferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 95 days, corresponding to the time needed to eliminate any study interventions (eg, 5 terminal half-lives) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •- A WOCBP must have a negative highly sensitive pregnancy
排除标准
- •1. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention.
- •2. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •3. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study intervention and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases confirmed by repeat imaging, and have not required steroids for at least 14 days before study intervention.
- •4. Has ocular melanoma
- •5. Has known hypersensitivity to active substances or any of their excipients including previous clinically significant hypersensitivity reaction to treatment with another monoclonal antibody
- •6. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- •7. Has an active infection requiring systemic therapy
- •8. Has known history of HIV (HIV 1/2 antibodies). No testing of HIV is required unless mandated by local health authority
- •9. Has known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (HCV RNA [qualitative] is detected). No testing of hepatitis B or C is required unless mandated by local health authority
- •10. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •11. Has a history of active tuberculosis
- •12. Has presence of a gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
- •13. Had had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
- •14. Has a pre-existing Grade =3 gastrointestinal or non-gastrointestinal fistula
- •15. Has radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy
- •16. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
- •17. Has clinically significant cardiovascular disease within 12 months from first dose of study drug, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- •18. Has urine protein =1 g/24-hour
- •19. Has prolongation of QTc interval (calculated using Fridericia’s formula) of >480 msec
- •20. Has LVEF below the institutional normal range as determined by MUGA or echocardiogram
- •21. Has received prior radiotherapy within 2 weeks of Cycle 1 Day 1. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
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