ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy in Participants with Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 40
- 主要终点
- (Phase 3): OS (Overall Survival) This study will assess if people live longer when they take Pumitamig compared to other standard treatment, nivolumab.
研究概览
简要总结
To compare 2 different doses of the new medicine (pumitamig) combined with chemotherapy to assess which of the 2 doses is better in controlling the cancer and/or has less side effects. The second stage, the dose of pumitamig which is found to be better will be compared against current licensed treatment (standard of care) to see if pumitamig plus chemotherapy controls cancer growth better than the current standard treatment.
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
- •Previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic GC, GEJC or distal EAC. GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
- •Documented PD-L1 ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study
- •Documented HER2-negative cancer, as determined according to local guidelines.
- •Measurable disease as defined by RECIST v1.1.
排除标准
- •Untreated known CNS metastases. Note: Participants are eligible if CNS metastases are adequately treated, and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. Note: Participants must have either discontinued corticosteroids or be on a stable or decreasing dose of ≤ 10 mg prednisone (or equivalent) daily for at least 2 weeks prior to randomization. Note: Baseline imaging required at screening must be performed 28 days after treatment for CNS metastases is completed. CNS metastases must be radiographically stable.
- •Significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- •Evidence of major coagulation disorders (eg, hemophilia).
- •History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose.
- •History of abdominal fistula or GI perforation within 6 months of randomization.
- •Major surgery, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
研究组 & 干预措施
CAPECITABINE, CAPECITABINE
干预措施: CAPECITABINE (Drug)
CALCIUM FOLINATE
干预措施: CALCIUM FOLINATE (Drug)
OXALIPLATIN
干预措施: OXALIPLATIN (Drug)
FLUOROURACIL
干预措施: FLUOROURACIL (Drug)
BNT327 50 mg ml, BNT327 20 mg ml
干预措施: BNT327 50 mg ml (Drug)
BNT327 50 mg ml, BNT327 20 mg ml
干预措施: BNT327 20 mg ml (Drug)
OPDIVO 10 mg/mL concentrate for solution for infusion.
干预措施: OPDIVO 10 mg/mL concentrate for solution for infusion. (Drug)
结局指标
主要结局
(Phase 3): OS (Overall Survival) This study will assess if people live longer when they take Pumitamig compared to other standard treatment, nivolumab.
(Phase 3): OS (Overall Survival) This study will assess if people live longer when they take Pumitamig compared to other standard treatment, nivolumab.
(Phase 2): ORR, to compare how two different doses of the study drug affect tumor growth to help select the better dose.
(Phase 2): ORR, to compare how two different doses of the study drug affect tumor growth to help select the better dose.
(Phase 3): PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of Pumitamig to work better than current standard treatment by assessing how long it takes before the cancer starts growing again by radiographic imaging techniques (like CT scans).
(Phase 3): PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of Pumitamig to work better than current standard treatment by assessing how long it takes before the cancer starts growing again by radiographic imaging techniques (like CT scans).
(Phase 3): OS (Overall Survival) This study will assess if people live longer when they take Pumitamig compared to other standard treatment. This is what is called "Overall Survival".
(Phase 3): OS (Overall Survival) This study will assess if people live longer when they take Pumitamig compared to other standard treatment. This is what is called "Overall Survival".
次要结局
- (Phase 2): Recommended dose of pumitamig for Phase 3
- (Phase 2): PFS (progression-free survival) by RECIST v1.1 per investigator assessment, defined as the time between the randomization date and the date of first documented tumor progression or death from any cause (whichever occurs first)
- (Phase 3): Duration of response (Partial Response or Complete Response) by RECIST v1.1 per investigator assessment, defined as the time between the date of the first documentation of objective tumor response (Complete Response or Partial Response) and the date of disease progression or to death from any cause (whichever occurs first)
- (Phase 2): Time to response (Complete Response or Partial Response) by RECIST v1.1 per investigator assessment, defined as the time between randomization to the date of the first documentation of objective tumor response
- (Phase 2): Disease control (Best overall response of confirmed Complete Response, confirmed Partial Response, or Stable Disease) by RECIST v1.1 per investigator assessment
- (Phase 3): Objective Response by RECIST v1.1 per BICR
- (Phase 3): Duration of response by RECIST v1.1 per BICR
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company