ISRCTN15021247进行中（未招募）2 期
A Phase II, open-label, multi-center study of PDS0101 (R-DOTAP [Versamune®] + HPVmix) and pembrolizumab (KEYTRUDA®) combination immunotherapy in subjects with recurrent and/or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The subject (or legally acceptable representative if applicable) provides written informed consent for the study
- •2. =18 years of age on the day of signing the informed consent.
- •3. Checkpoint-naïve subjects: have a history of histologically-confirmed diagnosis of squamous cell cancer of the head and neck (HNSCC) that is recurrent, metastatic, or persistent with:
- •3.1. Confirmed HPV16 infection
- •3.2. Confirmed tumor PDL1 expression defined as a combined positive score (CPS) =1 using the FDA-approved Dako PD-L1 immunohistochemistry (IHC) 22C3 PharmDx Assay
- •3.3. No prior receipt of any immunological therapy for metastatic disease
- •4. Checkpoint experienced subjects have a history of histologically-confirmed diagnosis of HNSCC that is recurrent, metastatic, or persistent with:
- •4.1. Confirmed HPV16 infection
- •4.2. Characterization of tumor PDL1 expression using the FDA-approved PD-L1 IHC 22C3 PharmDx Assay
- •4.3. Receipt of prior treatment with checkpoint inhibitors as a single agent or in combination, and have received at least 2 doses of the agent or a minimum of 6 weeks on treatment
- •4.4. Have documented clinical progression or recurrence that has been radiologically confirmed
- •5. Have recurrent and/or metastatic measurable disease based on RECIST 1.1 as assessed by the local Principal Investigator/radiology. There must be confirmation that the subject’s imaging shows at least 1 lesion that is appropriate for selection as a target lesion per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •6. Have adequate organ function as defined in hematological: ANC =1500/µl, platelets =100 000/µl; hemoglobin =9.0 g/dl or =5.6 mmol/l; renal: creatinine =1.5 × ULN or >1.5 × institutional ULN; hepatic: total bilirubin =1.5 × ULN or direct bilirubin =ULN for subjects with total bilirubin levels >1.5 × ULN, AST and ALT =2.5 ULN (5 × ULN for subjects with liver metastases); coagulation: INR, PTT =1.5 × ULN. Specimens must be collected within 10 days prior to the start of the study combination treatment.
- •7. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention
- •8. For female subjects defined as women of childbearing potential (WOCBP), a negative urine pregnancy test must be obtained during screening. Women who are surgically sterile or at least 2 years postmenopausal do not require pregnancy testing. Note: Female subjects of childbearing potential must be willing to use an effective method of contraception for the course of the study through 120 days after the last dose of study medication.
- •9. Male subjects of childbearing potential must agree to use a condom as an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
- •10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •1. A female subject defined as a WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •2. Has received prior therapy with an anti-PD-1, anti-PD- L1, or anti PD L2 agent with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) and was discontinued from that treatment due to a Grade 3 or higher adverse events (AE)
- •3. Has received prior systemic anticancer therapy including investigational agents within 30 days prior to treatment. Note: Subjects must have recovered from all AEs due to previous therapies to 4. Coordination and timing of coronavirus disease 2019 (COVID-19) vaccination should be based on local investigator clinical assessment and judgment. Note: Whenever possible, it is recommended to avoid COVID vaccination on the day of PDS0101 and/or pembrolizumab dosing because it may be difficult to attribute certain AEs (eg, fever, infusion reaction) to the study drug(s) or the COVID vaccine if they are both administered on the same day.
- •5. Has received prior radiotherapy within 2 weeks of the start of study treatment. Subjects 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.
- •6. Has received a live vaccine within 30 days prior to the first dose of 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.
- •7. Received immunotherapy/immunomodulatory or immunosuppressive agents (eg, IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers [GM-CSF, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 6 weeks prior to administration of the first study combination treatment
- •8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first dose of study treatment. Note: Subjects who entered the follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.
- •9. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft-versus-host disease [GVHD]).Diagnostic Assessments
- •10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
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