Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630130
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Platform Trial of Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer Neo-VIKTORY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric cancer GC is the fifth most commonly diagnosed cancer with over one million cases diagnosed annually worldwide Human epidermal growth factor receptor 2 HER2 overexpression in GC seen in 44 to 534 of patients in different reports is predictive biomarker of response to HER2-targeting therapies
Trastuzumab in combination with cisplatin or oxaliplatin and a fluoropyrimidine capecitabine or 5-fluorouracil 5-FU is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction GEJ cancer
Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety efficacy PK RO data as well as modeling analysis The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of 90 in the majority of participants across a broad spectrum of conditions
This is a phase II study to initially assess the efficacy of perioperative Trastuzumab Deruxtecan T-DXd and Capecitabine combination with or without Rilvegostomig in patients with HER2 positive locally advanced unresectable GC and potentially by subsequent protocol amendment in HER2 low locally advanced GC Other agents may also subsequently be assessed in this protocol by protocol amendments
Trastuzumab in combination with cisplatin or oxaliplatin and a fluoropyrimidine capecitabine or 5-fluorouracil 5-FU is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction GEJ cancer
Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety efficacy PK RO data as well as modeling analysis The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of 90 in the majority of participants across a broad spectrum of conditions
This is a phase II study to initially assess the efficacy of perioperative Trastuzumab Deruxtecan T-DXd and Capecitabine combination with or without Rilvegostomig in patients with HER2 positive locally advanced unresectable GC and potentially by subsequent protocol amendment in HER2 low locally advanced GC Other agents may also subsequently be assessed in this protocol by protocol amendments
Detailed Description:
Neoadjuvant therapy will begin following completion of the screening period and patients will undergo resection surgery 4 to 8 weeks after the last dose of neoadjuvant therapy Surgery 8 weeks after the last dose of neoadjuvant therapy may be permitted in consultation with the Sponsor Adjuvant therapy will begin 4 to 12weeks post-surgery based on the patients recovery period
Tumor evaluation using modified RECIST 11 will be conducted at screening within 28 days prior to first dose and 28 days after last dose of neoadjuvant therapy and after surgery
Every 12 weeks 1 week relative to the Adjuvant Baseline scan for first years and then every 24 weeks 2 week until progressionrecurrence
The imaging modalities used for modified RECIST 11 assessment will be CT or MRI scans of chest abdomen and pelvis Modified RECIST 11 scans will be analyzed by the investigator on site
Tumor evaluation using modified RECIST 11 will be conducted at screening within 28 days prior to first dose and 28 days after last dose of neoadjuvant therapy and after surgery
Every 12 weeks 1 week relative to the Adjuvant Baseline scan for first years and then every 24 weeks 2 week until progressionrecurrence
The imaging modalities used for modified RECIST 11 assessment will be CT or MRI scans of chest abdomen and pelvis Modified RECIST 11 scans will be analyzed by the investigator on site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None