2025-523735-19-00招募中3 期
A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 292
- 试验地点
- 83
- 主要终点
- PFS, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR (Blinded Independent Central Review) per RECIST v1.1 or death due to any cause.
研究概览
简要总结
To evaluate the efficacy of the combination of INCA33890 and SOC therapy versus placebo and SOC therapy.
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Aged 18 years or older, inclusive, at the time of signing the ICF.
- •Histologically or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV per the American Joint Committee on Cancer, Cancer Staging Manual, 8th Edition) not amenable to curative resection.
- •No prior systemic treatment for unresectable or metastatic CRC. Participants who previously received neoadjuvant and/or adjuvant therapy are allowed to enroll if there was no recurrence of disease within 12 months of last systemic therapy administration.
- •Radiographically measurable disease (based on local site investigator/radiology evaluation) per RECIST v1.1 criteria.
- •Adequate organ function as defined in the protocol
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Cancer History: Known MSI-H/dMMR status per local standard of practice as obtained from historical data in the participant's medical record.
- •Medical History: History of organ transplant, including allogeneic stem cell transplantation.
- •Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed.
- •Significant concurrent and/or uncontrolled medical condition as detailed in the protocol
- •Uncontrolled active HBV or HCV infection.
- •HIV positive, unless all of the following criteria are met: a. CD4+ count ≥ 350 μL. b. Undetectable viral load. c. Receiving highly active antiretroviral therapy.
- •Medications:
- •Current use of chronic systemic corticosteroids (ie, > 10 mg/day of prednisone or equivalent).
- •Received a live vaccine within 28 days before the first dose of study treatment.
- •Current use of prohibited medication as defined in the protocol.
- •Known complete DPD deficiency as reported in the participant's medical record. Local guidelines and regulations for DPD activity testing and dose adjustments should be applied in case of partial deficiency.
- •BRAF V600E mutation as obtained from historical data in the participant's medical record.
- •History of other malignancy within 2 years of study entry.
- •Untreated and/or progressing CNS metastases (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
- •Tumor known to invade or encase a major blood vessel or any history of clinically significant bleeding from tumor lesions within 30 days before enrollment.
- •Treatment with an anti–PD-(L)1 or anti–CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, for any indication within the past 3 years.
- •Toxicity from prior therapy that has not recovered to ≤ Grade 1 or baseline. Paresthesia and/or peripheral sensory neuropathy of Grade 2 or higher due to prior chemotherapy (eg, oxaliplatin) are exclusionary.
- •Concurrent anticancer therapy other than the therapies being tested in this study.
- •Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
研究组 & 干预措施
INCA33890
Test
干预措施: INCA33890 (Drug)
CALCIUM FOLINATE
Comparator
干预措施: CALCIUM FOLINATE (Drug)
Placebo contains the same formulation buffer, 10 mM acetate, 9% (w/v) sucrose and 0.02% (w/v) polysorbate 80, at pH 5.5, without the active pharmaceutical ingredient.
Placebo
干预措施: Placebo contains the same formulation buffer, 10 mM acetate, 9% (w/v) sucrose and 0.02% (w/v) polysorbate 80, at pH 5.5, without the active pharmaceutical ingredient. (Drug)
FLUOROURACIL
Comparator
干预措施: FLUOROURACIL (Drug)
OXALIPLATIN
Comparator
干预措施: OXALIPLATIN (Drug)
BEVACIZUMAB
Comparator
干预措施: BEVACIZUMAB (Drug)
结局指标
主要结局
PFS, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR (Blinded Independent Central Review) per RECIST v1.1 or death due to any cause.
PFS, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR (Blinded Independent Central Review) per RECIST v1.1 or death due to any cause.
次要结局
- OS, defined as the time from the date of randomization to the date of death due to any cause.
- Objective response, defined as CR or PR as determined by BICR (Blinded Independent Central Review) per RECIST v1.1.
- DOR, defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first.
- TEAEs per CTCAE v6.0 and TEAEs leading to dose interruption or study drug discontinuation.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (83)
Loading locations...
相似试验
招募中
2 期
Plan A Occlusion and Reversal System Feasibility StudyFertilityFertility, MaleHealthy Male AdultsNCT07361120Next Life Sciences40
招募中
2 期
An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell CarcinomaClear Cell Renal Cell CarcinomaNCT07469683Yonsei University78
尚未招募
3 期
OPEN-LABEL STUDY COMPARING MEZIGDOMIDE(CC-92480), BORTEZOMIB AND DEXAMETHASONE (MEZIVd) VERSUS POMALIDOMIDE, BORTEZOMIB AND DEXAMETHASONE (PVd) IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)CTRI/2024/10/074981Bristol Myers Squibb India Private Limited760
招募中
3 期
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple SclerosisMultiple SclerosisNCT07325292Sanofi160
招募中
2 期
Two drug therapy versus three drug therapy in resectable locally advanced oral cavity cancerCTRI/2024/07/071188AIIMS, New Delhi204