EUCTR2021-001309-60-CZ进行中（未招募）1 期
A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer
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
- 432
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. The participant must have histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable (Stage IV as defined by AJCC 8.ed)
- •2. Have measurable disease per RECIST 1.1 as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •3. Has been previously treated for their disease and radiographically progressed on or after or could not tolerate standard treatment, which must include ALL of the following agents if approved and locally available in the country where the participant is randomized:
- •a. Fluoropyrimidine, irinotecan and oxaliplatin.
- •b. With or without an anti-VEGF monoclonal antibody (eg, bevacizumab)
- •c. At least one of the anti-EGFR monoclonal antibodies (cetuximab or panitumumab) for Ras WT participants with left-sided tumors.
- •d. Participants with BRAF v600E mutations must have been treated with a RAF inhibitor with or without binimetinib. Participants with BRAF mutations that are not v600E are not required to have received RAF inhibitor therapy.
- •4. Submit an archival (= 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated, to enable central laboratory testing of PD-L1 and MMR status. FFPE blocks are preferred to slides.
- •5. Have ECOG PS of 0 to 1 within 10 days prior to first dose of study intervention.
- •6. Have a life expectancy of at least 3 months, based on the investigator assessment.
- •7. Have the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
- •8. Have adequate organ function as defined in the study protocol. Specimens must be collected within 10 days prior to the start of study intervention.
- •9. Is male or female, =18 years of age at the time of obtaining the informed consent.
- •10. 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: TAS-102 (90 days) and regorafenib (90 days). No contraception requirements are needed for males receiving MK-4280A.
- •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 OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to med. cause). Agree to use a male condom plus partner use of additional contraceptive method when having penile-vaginal intercourse with 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 CTs.
- •Female Participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not WOCBP OR
- •Is 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), as described in the protocol during the intervention period and for at
排除标准
- •1. Has previously been found to have dMMR/MSI-H tumor status determined by either IHC or PCR.
- •2. Has known active CNS metastases and/or carcinomatous meningitis or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid intervention for at least 14 days prior to first dose of study intervention.
- •3. Has a history of acute or chronic pancreatitis.
- •4. Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- •5. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- •6. Has urine protein = 1g/24h.
- •7. A WOCBP who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, anti-LAG-3 antibody, with a TKI (eg, lenvatinib) other than RAF inhibitors (if appropriate), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- •9. Has previously received regorafenib or TAS-102.
- •10. Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
- •11. 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.
- •12. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- •13. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study intervention.
- •14. 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 10 days prior the first dose of study medication.
- •15. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •16. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
- •17. 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.
- •18. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pne
研究者
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