ISRCTN80472712已完成1 期
A phase 1 first-in-human dose finding/randomised phase 2 study of IMM60 and pembrolizumab in advanced melanoma and NSCLC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
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
- All
入选标准
- •1. Aged >=18 years
- •2. Melanoma arms:
- •2.1. Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma
- •2.2. Result of BRAF mutation status (ie BRAF mutant or wildtype)
- •2.3. Phase 1:
- •2.3.1. IMM60 dose escalation arm: Patients progressing through at least one line of immunotherapy. For those patients with BRAF mutant tumours, progression through BRAF/MEK inhibitor treatment and at least one line of immunotherapy
- •2.3.2. IMM60 + pembrolizumab dose safety arm: Patients not previously exposed to a PD-1 inhibitor who fulfil NHS criteria for the funding of Pembrolizumab as determined by the Cancer Drugs Fund (CDF) (explained in separate appendix within the protocol) with the exception that pembrolizumab will not be administered as monotherapy.
- •2.4. Phase 2:
- •2.4.1. Melanoma Cohort 1: Patients with metastatic disease not previously exposed a PD-1 inhibitor
- •2.4.2. Melanoma Cohort 2: Patients with metastatic disease previously exposed to a PD-1 inhibitor
- •2.5. Patients in Melanoma Cohort 1 must meet CDF criteria for funding for pembrolizumab, Melanoma Cohort 2 patients do not need to meet these criteria.
- •3. NSCLC arms:
- •3.1. Histologically confirmed stage 4 non-small cell lung cancer
- •3.2. Patients with adenocarcinoma histology must not have sensitizing EGFR or ROS1 mutations or ALK translocations
- •3.3. No prior systemic therapy for advanced disease. Previous chemotherapy in the context of adjuvant treatment is permissible as long as the treatments were completed at least 6 months prior to consent
- •3.4. Patients in non-small cell lung cancer arms must have a PD-L1 assessment prior to randomization. PDL1 assessment must be performed in an approved laboratory
- •3.5. Phase 1:
- •3.5.1. IMM60 dose escalation arm: Progression through systemic therapy consisting of at least platinum based chemotherapy and immunotherapy (either sequentially or in combination)
- •3.5.2. IMM60 + pembrolizumab dose safety arm: First line treatment for patients who fulfil NHS criteria for the funding of Pembrolizumab as determined by the Cancer Drugs Fund (CDF)(detailed in separate appendix) with the exception that pembrolizumab will not be administered as monotherapy
- •3.6. Phase 2:
- •3.6.1. NSCLC Cohort 1: Metastatic NSLC, PDL1 +ve (PDL1 TPS greater than or equal to 50%) not previously exposed to a PD-1 inhibitor
- •3.6.2. NSCLC Cohort 2: Metastatic NSLC, PDL1 –ve (PDL1 < 50%) not previously exposed to a PD-1 inhibitor but pre-treated with at least one line of systemic treatment
- •3.7. Patients in NSCLC Cohorts 1 must meet CDF criteria for funding for pembrolizumab, with the exception of pembrolizumab administration as monotherapy
- •4. At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria. Cutaneous lesions and other superficial lesions detectable only by physical examination are not measurable lesions however may be considered non-target lesions.
- •5. ECOG performance score of 0 or 1.
- •6. Life expectancy of at least 12 weeks.
- •7. The patient is willing to give consent to the main study and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations.
- •8. Prior systemic treatments must have been completed at least 4 weeks prior to enrolment and all toxicities have either returned to baseline or resolved to less than or equal to grade 1 with the exception of alopecia. For patients with melanoma previously treated with a target tyrosine kinase inhib
排除标准
- •1. Any anti-cancer therapy (including radiotherapy and participation in other clinical trials) within 28 days except tyrosine kinase inhibitors in which case 2 weeks prior to Day 1
- •2. Any unresolved toxicity from prior anti-cancer therapy that is greater than CTCAE grade 2
- •3. Pregnant or breastfeeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post-menopausal status (defined as absence of menstruation for > 12 months, bilateral oophrectomy or hysterectomy)
- •4. Patients with non-small cell lung cancer with large volume tumour burden, who, at the investigator’s discretion are considered more appropriate for systemic chemotherapy
- •5. Patients of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (both male and female patients)
- •6. Known severe hypersensitivity reactions to anti-PD1 agents or has received prior therapy with an agent directed towards PD1/PDL1 or to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE (except IMM60 monotherapy cohort who can have received prior PD1)
- •7. Ocular or mucosal malignant melanoma
- •8. Another active malignancy within the past two years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Also, prostate, breast and neuroendocrine tumours that are stable on hormonal treatment for a period of 1 year or more without the need to adjust dose are not excluded.)
- •9. Evidence of brain metastases, unless surgically resected/stereotactic radiosurgery treated brain metastasis and stable off treatment, including steroids, for 8 weeks
- •10. Clinically significant and uncontrolled major medical condition(s): such as active infection, bleeding diathesis
- •11. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV. Testing is not required unless clinically indicated
- •12. Cardiac conditions, defined by uncontrolled hypertension (BP> 160/100 despite treatment), heart failure NYHA class 2 or above, myocardial infarction within 6 months or angina requiring nitrate therapy more than once a week
- •13. Previous treatment with anti -PD1 antibodies for experimental arms: (cohort 3 for melanoma in the phase 2 trial) or all cohorts in NSCLC.
- •14. Severe hypersensitivity (> = Grade 3) to pembrolizumab and/or any of its excipients
- •15. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •16. Has an active infection requiring systemic therapy
- •17. Prior treatment with IMM60
- •18. Patients with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids (in dosing exceeding 10 mg daily of prednisone equivalent) or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement will not be excluded from the study
- •19. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: meas
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