Metastatic Gastric Cancer Clinical Trial
Official title:
A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma
Participants will receive study treatment with agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. When participants start each agent will depend on how their disease is affecting them.
Status | Recruiting |
Enrollment | 38 |
Est. completion date | August 1, 2027 |
Est. primary completion date | August 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction - Disease progression on one prior line of therapy for metastatic disease - Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma - Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle - Age 18 years or older - ECOG performance status 0 to 1 - Adequate organ function as defined in Table 2 Table 2. Organ function requirements for eligibility Hematological Absolute neutrophil count: =1000/mcL Platelets: =90,000/mcL Hemoglobin: =8 g/dL Renal Serum creatinine: =1.5X ULN Hepatic Serum total bilirubin: =1.5X ULN OR Direct bilirubin =ULN for subjects with total bilirubin levels >1.5X ULN, except patients with Gilbert's disease (=3X ULN) AST and ALT: =2.5X ULN Albumin: =3 mg/dL Exclusion Criteria: - Received prior therapy with ramucirumab at any time - Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment - Had a prior grade >3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time - Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed. - History of gastrointestinal perforation or fistulae - A known history of active Bacillus tuberculosis - Known active central nervous system metastases and/or carcinomatous meningitis - History of or any evidence of active, non-infectious pneumonitis - Peripheral neuropathy limiting ADLs - A known history of human immunodeficiency virus (HIV 1/2 antibodies) - Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team. - Received a live vaccine within 30 days of planned start of study therapy - Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment - Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York |
United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | Determine the efficacy of agenT-797, botensilimab and balstilimab in combination with ramucirumab and paclitaxel as second-line therapy in patients with advanced unresectable or metastatic esophagogastric cancer, as measured by ORR (defined as the percentage of patients who achieve either an objective complete response [CR] + partial response [PR]) | up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04618809 -
Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
|
N/A | |
Recruiting |
NCT02668380 -
An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer
|
N/A | |
Completed |
NCT03121807 -
Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
|
N/A | |
Recruiting |
NCT04358354 -
Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer
|
Phase 3 | |
Completed |
NCT01099527 -
A Trial of RAD001/Capecitabine in Refractory Gastric Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00253370 -
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
|
Phase 2 | |
Recruiting |
NCT02002195 -
Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer
|
||
Recruiting |
NCT06008925 -
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05714124 -
Liver Embolization Approaches for Tumor Management
|
||
Recruiting |
NCT02855788 -
Metronomic Chemotherapy in Advanced Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT03154983 -
The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric Cancer
|
Phase 2 | |
Not yet recruiting |
NCT04263870 -
Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
|
Phase 2 | |
Active, not recruiting |
NCT01359397 -
Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04739202 -
Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent GASTric Adenocarcinoma (IMMUNOGAST)
|
Phase 2 | |
Completed |
NCT03409848 -
Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in HER2 Positive EsophagoGastric Adenocarcinoma
|
Phase 2 | |
Recruiting |
NCT05859477 -
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05955833 -
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
|
Phase 1 | |
Terminated |
NCT01528501 -
Histone Deacetylases - Gastric Cancer (HDAC-GaCa-2008)
|
Phase 2 | |
Completed |
NCT03751761 -
GC 2nd Line Durvalumab(MEDI4736)/Tremelimumab Plus Paclitaxel Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT05024812 -
Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 1/Phase 2 |