2025-523617-29-01招募中2 期
Tolerability and efficacy of treating locally advanced Resectable Oral Cancer with neoadjuvant INtratumoral anti-CTLA4 ImmunoTherapy combined with systemic anti-PD-1 (ROCinIT).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the tolerability, and efficacy of neoadjuvant intratumoral anti-CTLA-4 combined with systemic anti-PD-1 immunotherapy prior to surgery for locally advanced oral cancer.
研究概览
简要总结
Tolerability and efficacy of treating locally advanced Resectable Oral Cancer with neoadjuvant INtratumoral anti-CTLA4 ImmunoTherapy combined with systemic anti-PD-1 (ROCinIT).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Have a histologically confirmed diagnosis of T2–T4, N0–N3b, M0 disease and be scheduled for treatment with curative intent, including surgical resection.
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab w/ ipilimumab and who are sexually active with WOCBP will be instructed to adhere to contraception during the study and for 31 weeks after the last dose of the investigational product.
- •Be willing and able to provide written informed consent for the trial.
- •Be 18 years of age or older on day of signing informed consent.
- •No immunosuppressive medication within 6 months prior to study inclusion.
- •No hard-drug abuse.
- •Must agree to provide tissue from fresh tumor biopsy pretreatment, on-treatment biop-sy (when feasible) and from the surgical resection material to determine the actual PD-L1 status and perform histopathological examination for response, as well as immunomoni-toring/DNA/RNA profiling.
- •Have a performance status of 0-1 on the Eastern Cooperative Oncology Group Perfor-mance Scale
- •Demonstrate adequate organ function. All screening labs should be performed within 2 weeks before any study imaging procedures are performed.
- •Women of childbearing potential (WOCBP) must use appropriate method(s) of contra-ception during the study and for 23 weeks after the last dose of nivolumab. Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
排除标准
- •Has distant metastasis.
- •Is pregnant or breastfeeding, or expecting to conceive children within the projected dura-tion of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check-point pathways.
- •Has known active Hepatitis B or C.
- •Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •Has a known current additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- •If subject received major surgery for any other reason, they must have recovered ade-quately from the toxicity and/or complications from the intervention prior to starting ther-apy.
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -
- •Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily predni-sone equivalent, are permitted in the absence of active autoimmune disease.
- •Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
- •Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
研究组 & 干预措施
IPILIMUMAB
Test
干预措施: IPILIMUMAB (Drug)
NIVOLUMAB
Test
干预措施: NIVOLUMAB (Drug)
结局指标
主要结局
To evaluate the tolerability, and efficacy of neoadjuvant intratumoral anti-CTLA-4 combined with systemic anti-PD-1 immunotherapy prior to surgery for locally advanced oral cancer.
To evaluate the tolerability, and efficacy of neoadjuvant intratumoral anti-CTLA-4 combined with systemic anti-PD-1 immunotherapy prior to surgery for locally advanced oral cancer.
次要结局
- To compare clinical outcome and toxicity data to Nivolumab alone and systemic anti-CTLA-4 + anti-PD-1.
- To investigate immune activation in peripheral blood pre-, on- and post-treatment between patients with a CR/MPR and non-responders.
- To investigate immune activation in the tumor in pre- on- and post-treatment biopsies, and post treatment tdLNs between patients with a CR/MPR and non-responders
- To investigate the molecular profile of the tumor (e.g. presence of copy number alterations) in relation to response to the treatment and immune parameters.
- To assess whether baseline, and/or on treatment MRI perfusion patterns, and treatment induced changes, relate to pathological response and to CD8 T cell infiltration patterns (T-cell excluded versus T-cell inflamed tumor microenvironments)
- The circulating cell free DNA or RNA kinetics of longitudinal plasma samples at baseline, during neoadjuvant immunotherapy and post-surgery will be linked to pathological response
研究者
PI of the study
Scientific
Amsterdam UMC Stichting
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A clinical trial to compare the effect of two neoadjuvant chemotherapy drug regimens in technically unresectable head and neck cancer.CTRI/2024/10/075166Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital Sawangi Wardha50
尚未招募
2 期
H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)Head and Neck CancerNCT07484139UNC Lineberger Comprehensive Cancer Center26
进行中（未招募）
2 期
Tirellizumab Combined With TP Neoadjuvant Therapy in the Treatment of Early Oral Squamous Cell Carcinoma （HNC-SYSU-005）NCT07267286Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University60
招募中
不适用
Response to Neoadjuvant Treatment in Locally Advanced Thyroid CancerThyroid CancerNCT07419932Fujian Medical University120
招募中
2 期
A Phase II, Open-Label, Single-Arm, Multicentre Study of Carboplatin, Paclitaxel, and Tislelizumab in Biomarker-Selected Patients with Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma - PERSEPHONE Trial2024-517565-16-00Gruppo Oncologico Del Nord Ovest28