NL-OMON48631已完成不适用
A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors - MS201781-0031
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Merck KGaA
- 入组人数
- 7
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •UrothelialSigned written informed consent
- •2. Male or female subjects age * 18 years
- •3. Subjects must have one of the following tumor specific indications:
- •-a. Locally advanced or metastatic urothelial carcinoma (UC) post-that has
- •progressed during or after at least one platinum:-based chemotherapy and not
- •previously been treated with anti-PD-1/PD-L1 agents (PD-x naïve):
- •Histologically or cytologically confirmeddocumented locally advanced or
- •metastatic transitional cell carcinoma of the urothelium (including renal
- •pelvis, ureters, urinary bladder, and urethra). Subjects must have progressed
- •during or after treatment with at least 1 platinum -containing regimen (eg,
- •platinum plus another agent such as gemcitabine, methotrexate, vinblastine,
- •doxorubicin, etc) for inoperable locally advanced or metastatic UC or disease
- •recurrence. Availability of either tumor archival material or fresh
- •biopsiesSubjects who received prior adjuvant/neoadjuvant chemotherapy and
- •progressed within 28 days is acceptable12 months of treatment with one of these
- •being mandatory. For FFPE samples, either block or sections (> 15) maya
- •platinum-containing regimen will be provided. Tumor biopsies and tumor archival
- •material must be suitable for biomarker assessment.considered as second line.
- •Subjects with mixed histologies are required to
- •have a dominant transitional cell pattern
- •b. Non-small cell lung cancer, first-line metastatic: Histologically proven
- •Stage IV (per seventh International Association for the Study of Lung Cancer
- •classification) NSCLC.
- •Subjects must not have received treatment for their metastatic disease.
- •Subjects could have received adjuvant chemotherapy or loco-regional treatment
- •that included chemotherapy for locally advanced disease, as long as disease
- •recurrence occurred at least 6 months after the completion of the last
- •administration of chemotherapy. Only epidermal growth factor receptor (EGFR)
- •and anaplastic lymphoma kinase (ALK) wild-type are allowed (ie, EGFR mutation
- •and ALK translocation / rearrangement excluded). Non squamous cell histologies
- •and never / former light smoker (< 15 pack years) squamous cell carcinoma
- •subjects (per local standard of care) require testing if status is unknown.
- •Subjects must have low tumor PD-L1 expression defined as < 50% tumor proportion
- •score determined using PD-L1 IHC 22C3 pharmDx test or an equivalent
- •FDA-approved PD-L1 test. This cohort will not be opened for enrollment in
- •Belgium, Czech Republic, France, Germany,
- •Hungary, Italy,
- •Netherlands, Spain, and United Kingdom
- •c. Colorectal cancer, second line or later: Histologically or cytologically
- •confirmed recurrent or refractory metastatic CRC (according to American Joint
- •Committee on Cancer / International Union Against Cancer Tumor Node Metastasis
- •[TNM] Staging System seventh edition) after failure of prior therapy containing
- •oxaliplatin / fluoropyrimidine and / or irinotecan / fluoropyrimidine and, if
- •eligible, cetuximab (Erbitux®) and bevacizumab (Avastin®). Only subjects with
- •MSI-low or MSS metastatic CRC are eligible.
- •Subjects without existing MSI test results will have MSI status
- •- performed locally by a CLIA-certified IHC or PCR-based test
- •(PCRbasedPCR-based MSI test is preferred). Subjects must be willing to undergo
- •an ontreatment biopsy procedure. For Belgium, Czec
排除标准
- •1. Concurrent treatment with a non-permitted drug/intervention (listed below)
- •a. Anticancer treatment (eg, cytoreductive therapy, radiotherapy, immune
- •therapy, cytokine therapy, monoclonal antibody, targeted small molecule
- •therapy) or any investigational drug within 4 weeks or 5 half-lives, whichever
- •is shorter, prior to start of study treatment, or not recovered from adverse
- •events (AE) related to such therapies, with the following exceptions:
- •i. Palliative radiotherapy delivered in a normal organ-sparing technique is
- •permitted (concurrently or within pretreatment period).
- •ii. Erythropoietin, darbepoetin-*, and granulocyte colony-stimulating factor
- •are permitted.
- •iii. Hormonal therapies acting on the hypothalamic pituitary gonadal axis are
- •permitted (ie, luteinizing hormone releasing hormone agonist/antagonists). No
- •other hormonal anticancer therapy is permitted.
- •b. Major surgery (as deemed by Investigator) for any reason (except diagnostic
- •biopsy) within 4 weeks prior to start of study treatment, or not fully
- •recovered from surgery within 4 weeks prior to start of study treatment
- •c. Subjects receiving immunosuppressive agents (such as steroids) for any
- •reason should be tapered off these drugs before start of study treatment, with
- •the following exceptions:
- •i. Subjects with adrenal insufficiency, may continue corticosteroids at
- •physiologic replacement dose, equivalent to * 10 mg prednisone daily.
- •ii. Administration of steroids through a route known to result in a minimal
- •systemic exposure (topical, intranasal, intra-ocular, or inhalation) is
- •iii. Previous or ongoing administration of systemic steroids for the management
- •of an acute allergic phenomenon is acceptable as long as it is anticipated that
- •the administration of steroids will be completed in 14 days, or that the dose
- •after 14 days will be equivalent to * 10 mg prednisone daily.
- •2. Any prior treatment with any form of IL-12
- •3. For the NSCLC, CRC, and UC expansion cohorts, prior therapy with any
- •antibody / drug targeting T cell co regulatory proteins (immune checkpoints)
- •such as anti-PD-1, anti PD L1, or anticytotoxic T lymphocyte antigen-4 (CTLA 4)
- •antibody is prohibited
- •4. Intolerance to checkpoint inhibitor therapy, as defined by the occurrence of
- •an AE requiring drug discontinuation.
- •5. Active or history of primary or metastatic central nervous system tumors
- •6. Prior organ transplantation, including allogeneic stem cell transplantation
- •7. Previous malignant disease (other than the indication for this study) within
- •the last 5 years (except adequately treated nonmelanoma skin cancers, carcinoma
- •in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a
- •complete remission without further recurrence was achieved at least 2 years
- •prior to study entry and the subject was deemed to have been cured with no
- •additional therapy required or anticipated to be required.
- •8. Significant acute or chronic infections requiring systemic therapy
- •including, among others:
- •a. History of testing positive test for human immunodeficiency virus (HIV) or
- •known acquired immunodeficiency syndrome
- •b. Hepatitis B or C infection (HBV surface antigen positive and HBV core
- •antibody positive with reflex to positive HBV DNA or HBV core antibody positive
- •alone with reflex to positive HBV DNA or positiv
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