EUCTR2021-001244-95-ES进行中（未招募）1 期
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) - Pembrolizumab and chemotherapy for newly diagnosed classical Hodgkin Lymphoma
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
- 140
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. Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV cHL. Stage I and II patients may be enrolled, but must have at least one NCCN unfavorable risk factor
- •2. Has measurable FDG-avid disease based on investigator assessment according to Lugano 2014 response criteria
- •3. Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy(including investigational agents) for the treatment of cHL before the first dose of study intervention
- •4. Is male or female, at least 18 years of age, at the time of signing the informed consent
- •5. Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows:
- •Pembrolizumab: no contraception requirement
- •Chemotherapy: 90 days
- •Refrain from donating sperm
- •PLUS either:
- •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) 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
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed
- •6. 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 WOCBP
- •Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, 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 the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
- •The length of time required to continue contraception for each study intervention is as follows:
- •Chemotherapy: 180 days
- •Pembrolizumab: 120 days
- •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 test (urine or serum as required by local regulations) within 72 hours before the first dose of study intervention
- •- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- •- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
- •- Contraceptive use by women should be consistent with
排除标准
- •1. Has confirmed nodular lymphocyte-predominant HL
- •2. Has an uncontrolled intercurrent cardiovascular illness including, but not limited to the following:
- •Symptomatic congestive heart failure (ejection fraction lower than institutional LLN)
- •Unstable angina pectoris
- •Cardiac arrythmia
- •3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
- •4. Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- •5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- •6. 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 the first dose of study medication. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor
- •7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- •8. Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by investigator at the time of diagnosis
- •9. Has severe hypersensitivity (=Grade 3) to any of the study interventions or their excipients
- •10. 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
- •11. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •12. Has a history or current evidence of pulmonary fibrosis
- •13. Has an active infection requiring systemic therapy
- •14. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority
- •15. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •17. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
- •18. Has any contraindication to the use of any of the chemotherapeutic agents used in the study
- •19. Has not recovered adequately from surgery and/or any complications from the surgery
- •20. Has had an allogenic tissue/solid organ transplant
研究者
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