NL-OMON49921撤回2 期
A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined with Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients with Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors (PROPEL-36) - PROPEL-36
ektar Therapeutics0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 6
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Provide written, informed consent to participate in the study and follow the
- •study procedures.
- •* Male or female patients, age 18 years or older on the day of signing the
- •informed consent form.
- •* Have histologically or cytologically-confirmed recurrent or metastatic HNSCC
- •that is considered incurable by local therapies.
- •o No prior systemic therapy for recurrent or metastatic disease. Systemic
- •therapy given as part of multimodal treatment for locally advanced disease is
- •allowed if completed more than 6 months prior to signing consent.
- •o The eligible primary tumor locations are oropharynx, oral cavity,
- •hypopharynx, and larynx.
- •o Patients may not have a primary tumor site of nasopharynx (any histology)
- •and/or unknown primary.
- •* Have measurable disease based on RECIST 1.1 as determined by the local site
- •Investigator. Tumor lesions situated in a previously irradiated area are
- •considered measurable if progression has been shown in such lesions since
- •irradiation.
- •* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •* Tumor tissue from a core, incisional, or excisional biopsy (fine needle
- •aspirates are not acceptable) to the central laboratory for determination of PD
- •L1 status (if not determined at local laboratory) and exploratory biomarker
- •analyses. A newly obtained biopsy is strongly preferred, but archival tumor
- •biopsy may be used and provided.
- •* The tumor must have positive PD-L1 expression (ie, CPS * 1) as determined
- •with the PD-L1 IHC 22C3 PharmDx diagnostic kit at either a local or central
- •laboratory.
- •* Patients with oropharyngeal cancer: must have results from testing of HPV
- •status defined as p16 IHC testing using CINtec® p16 Histology assay (Ventana
- •Medical Systems Inc., Tucson AZ). If HPV status was previously tested using
- •this method, no additional testing is required. Note:
- •o If local p16 testing results are not available, or cannot be assessed by the
- •specified method, a tumor tissue sample may be submitted to the central
- •laboratory for p16 testing.
- •Patients with oral cavity, hypopharynx, or larynx cancers: HPV testing by p16
- •IHC is not required as by convention these tumor locations are assumed to be
- •HPV negative.
排除标准
- •* Has disease that is suitable for local therapy administered with curative
- •* Has progressive disease within 6 months of completion of curatively intended
- •systemic treatment for locoregionally advanced HNSCC.
- •* Has had radiation therapy (or other non-systemic therapy) within 2 weeks
- •prior to initiation of study drug, or patient has not fully recovered (ie, *
- •Grade 1 or at baseline) from AEs due to a previously administered treatment. A
- •1 week washout is permitted for palliative radiation (* 2 weeks of
- •radiotherapy) to non-central nervous system (CNS) disease. Note:
- •o Patients with * Grade 2 neuropathy or * Grade 2 alopecia are an exception to
- •this criterion and qualify for the study.
- •o If patient received major surgery, they must have recovered adequately from
- •the toxicity and/or complications from the intervention prior to starting
- •* Has a life expectancy of less than 3 months and/or has rapidly progressing
- •disease (eg, tumor bleeding, uncontrolled tumor pain) as determined by
- •Investigator.
- •* Has a known additional malignancy that is progressing or has required active
- •treatment within 5 years prior to the first dose of study drug with the
- •exception of: curatively treated basal cell carcinoma of the skin, squamous
- •cell carcinoma of the skin, curatively resected in situ cervical cancer, and
- •curatively resected in situ breast cancer.
- •* Has an active autoimmune disease that has required systemic treatment in the
- •past 2 years (ie, with use of disease modifying agents, corticosteroids or
- •immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
- •physiologic corticosteroid replacement therapy for adrenal or pituitary
- •insufficiency) is not considered a form of systemic treatment and is allowed.
- •* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
- •or any other form of immunosuppressive therapy within 7 days prior to the first
- •dose of study drug. Corticosteroid use as pre-medication for allergic reactions
- •(eg, intravenous [IV] contrast) is allowed. The use of physiologic doses of
- •corticosteroids may be approved after consultation with the Sponsor.
研究者
相似试验
撤回
2 期
A Randomized, Open-Label Phase 2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma.NL-OMON55480Eli Lilly1
撤回
3 期
A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected SubjectsHuman Immunodeficiency visrus (HIV-1) infections10047438NL-OMON42500Gilead Sciences20
撤回
2 期
A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT).MYELODYSPLASTIC SYNDROMES (MDS)1003522710024324NL-OMON46021Celgene Corporation40
撤回
2 期
A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain MetastasisNL-OMON49456Array Biopharma Inc.10
撤回
3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a TriggerNL-OMON51930PPD4