A Phase 2 Study of Pembrolizumab (MK-3475) every 6 weeks (Q6W) in Participants with Relapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) -

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 60 人开始时间: 2021年6月7日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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. Male/female participants who are at least 18 years of age on the day of signing informed consent.
•2. Have a histologically confirmed diagnosis of cHL or PMBCL, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues [Swerdlow, S. H., et al 2008].
•3. Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is >15 mm in long axis, regardless of the length of the short axis, AND/OR extranodal lesion of >10 mm in long and short axis.
•4. Have relapsed or refractory PMBCL and:
•Have relapsed after auto-SCT or have failed to achieve a CR or PR within 60 days of auto-SCT. Participants may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
•For participants who are ineligible for auto-SCT, have received at least =2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen. For participants who received consolidative local radiotherapy after systemic therapy, local radiotherapy will not be considered as a separate line of
•5. Have relapsed or refractory cHL and:
•Have relapsed during their last cHL regimen after receiving at least 2 cycles of therapy or within 12 months after completing the last regimen for cHL.
•Have received at least =1 line of prior multiagent therapy with/without brentuximab vedotin (excluding radiation) or auto-SCT for cHL and have failed to respond to or relapsed after their last line of treatment.
•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), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 of the protocol 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 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 24 hours for urine or within 72 hours for serum before the first dose of study.
•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.
•Additional requirements for pregnancy testing during and after study intervention are located in the protocol
•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 local regulations regarding the methods of contraception for those participating in clinical studies.
•For the remaining inclusion criteria refer to Protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes

排除标准

•1. Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic SCT within the last 5 years. Participants who have had allogeneic hematopoietic SCT >5 years ago are eligible as long as there are no symptoms of GVHD.
•2. Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class =II), or serious cardiac arrhythmia requiring medication.
•3. Has pericardial effusion or clinically significant pleural effusion.
•4. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
•5. Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) <3 days prior to the first dose of study intervention.
•6. Has received prior monoclonal antibody within 4 weeks prior to first dose of study intervention or has not recovered (ie, =Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.
•7. 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).
•8. Has received prior CAR-T therapy.
•9. Has received prior systemic anticancer therapy, or radiotherapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
•10. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
•11. Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug.
•12. 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.
•13. 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.
•14. Has known active CNS lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease) and clinical remission.
•15. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
•16. 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.
•17. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
•18. Has an active infection requiring systemic therapy.
•For the rest of the exclusion criteria please refere to Protocol

研究者

发起方

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

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