NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer

Официальное название

A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer

Обзор

The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.

Вмешательства

• Препарат Oxaliplatin
  65mg/m2 will be administered as a 120 minute IV Infusion (-10/+ 20 minutes) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
• Препарат Irinotecan
  150 mg/m2 will be administered as a 90 minute IV Infusion (-10/+ 20 minutes) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
• Препарат Folinic Acid
  50 mg will be administered as a 15 minute IV infusion (-5/+20 min) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. Folinic acid can be given concurrent with irinotecan. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
• Препарат 5-Fluorouracil (5-FU)
  2400 mgm2 will be administered as a continuous IV Infusion (-120/+ 120 minutes) over approximately 46 hours on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
• Препарат NC410
  100 mg will be administered as a 60 minute IV Infusion (-10/+ 20 minutes) on day 1 of each cycle every 2 weeks. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
• Препарат Nivolumab
  400 mg will be administered as a 30 minute IV Infusion (-5/+20 minutes) once on Cycle 1 Day 1. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).
• Препарат Ipilimumab
  50 mg will be administered as a 30 minute IV Infusion (-5/+20 minutes) once on Cycle 1 Day 1. Each cycle length is 14 days. The two arms will enroll sequentially (starting with Arm 1 followed by Arm 2).

Первичные конечные точки

• Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation. [Срок оценки: 4 years]

Вторичные конечные точки (4)

• Progression- Free Survival (PFS) [Срок оценки: 4 years]
• Response Rate (ORR) [Срок оценки: 4 years]
• Disease Control Rate (DCR) [Срок оценки: 4 years]
• Overall Survival (OS) [Срок оценки: 4 years]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
• Metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
• Have metastatic disease
• Must not have received prior systemic treatment for pancreatic cancer.
• Have measurable disease based on RECIST 1.1.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
• For both Women and Men, must use acceptable form of birth control while on study.
• Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines.

Критерии исключения

• Have had prior chemotherapy for pancreatic cancer or prior chemotherapy within 5 years of enrollment for other cancer diagnoses.
• Has received radiotherapy for pancreatic cancer.
• Are receiving or have received any investigational agent or used an investigational device within 28 days prior to Day 1 of treatment in this study.
• Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study.
• Is expected to require any other form of systemic or localized antineoplastic therapy while on study.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies.
• Has received a live vaccine or live-attenuated vaccine within 28 days prior to the first dose of study drug.
• Prior tissue or organ allograft regardless of need for immunosuppression, including corneal allograft.
• Has uncontrolled acute or chronic medical illness.
• Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has known additional malignancy that is progressing and requires active treatment.
• Has active autoimmune disease.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Requirement for daily supplemental oxygen.
• History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
• Known history of human immunodeficiency virus (HIV).
• Active or chronic hepatitis B or hepatitis C.
• Unable to undergo venipuncture and/or tolerate venous access.
• Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.
• Pregnant or breastfeeding
• A WOCBP who has a positive urine pregnancy test within 72 hours prior to study drug initiation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sidney Kimmel Comprehensive Cancer Center — Baltimore

Идентификаторы

NCT: NCT06941857 · J2541 · IRB00486324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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