EUCTR2018-001974-76-FR进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630) - Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC
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
- 570
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. Participants must have histologically confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
- •2. Participant must have undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. Surgery may consist of 1 or a combination of the following:
- •a. Resection of the primary lesion
- •b. Any type of neck dissection(s)
- •c. Any type of parotidectomy (superficial, total, partial)
- •3. Participant must have histologically confirmed LA cSCC with a high-risk feature(s) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
- •High-risk features include at least 1 of the following:
- •a) Histologically involved nodal disease that has at least 1 of the following features:
- •Any extracapsular extension
- •=3 regional lymph nodes per primary site (affected regional sites and associated draining lymph nodes)
- •1-2 involved lymph nodes with any node =3 cm in greatest diameter, independent of extracapsular extension
- •b) Any index tumor with =2 of the following high risk features:
- •Tumor =4 cm with a depth >6 mm
- •Multi-focal perineural invasion for nerves of <0.1 mm diameter or any involved nerve =0.1 mm diameter
- •Invasion beyond subcutaneous fat
- •Poor differentiation and/or sarcomatoid and/or spindle cell histology
- •Recurrent disease (any cSCC that recurs within 3 years in the previously surgically or topically treated area)
- •c) Any gross cortical bone invasion or skull base invasion and/or skull base foramen invasion
- •d) Any index tumor that is resected with microscopic residual positive surgical margins
- •4. Participant must have completed adjuvant RT for LA cSCC with last dose of RT =4 weeks and =16 weeks from randomization
- •5. Participant must have completed at least 50 Gy 25 fractions of adjuvant RT for LA cSCC prior to study entry
- •6. Participant is disease-free as assessed by the investigator with complete radiographic staging assessment =28 days from randomization
- •7. Participant is male or female and at least 18 years of age at the time of signing the informed consent
- •8. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •- Is not a woman of childbearing potential (WOCBP)
- •- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis),during the intervention period and for at least 120 days after the last dose of study intervention The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in r
排除标准
- •1. Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
- •2. Has any other histologic type of skin cancer other than invasive cSCC, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen’s disease, MCC, melanoma
- •3. A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- •4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another costimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
- •5. Has received prior systemic anticancer therapy including investigational agents for cSCC within 4 weeks prior to randomization
- •6. Participant must have recovered from all radiation-related toxicities, not have required corticosteroids, and not have had radiation pneumonitis
- •7. Has received a live vaccine within 30 days prior to the first dose of study treatment.Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
- •8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
- •9. 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 prior to the first dose of study drug
- •10. Has a diagnosed and/or treated additional malignancy within the past 5 years prior to randomization
- •11. Has known active central nervous system metastases and/or carcinomatous meningitis
- •12. Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients
- •13. Has an active autoimmune disease that has required systemic treatment in 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
- •14. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •15. Has an active infection requiring systemic therapy
- •16. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
- •17. Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection
- •18. Has a history or current evidence of
研究者
相似试验
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVRespiratory Syncytial VirusMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-002023-11-HUJanssen-Cilag International NV737
进行中（未招募）
1 期
Efficacy and safety of adding LX4211 (an investigational oral compound) for patients with Type 1 Diabetes Mellitus (T1D) who have inadequate control of their blood glucose (sugar) levels on insulin alone.Type 1 Diabetes MellitusEUCTR2014-005153-39-LTexicon Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVEUCTR2020-002023-11-SEJanssen-Cilag International NV737
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2014-004464-38-NLAmgen Inc852
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)Immunoglobulin A Nephropathy (IgAN)EUCTR2020-003084-26-CZChinook Therapeutics U.S., Inc.320