Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring HER2+, HER2-positive, CRC, Gastric cancer, Esophageal cancer, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:
Cohorts 1A, 1B, 1C, and 1D
- CRC
- Gastric adenocarcinoma
- GEJ adenocarcinoma
- Esophageal adenocarcinoma
- Cholangiocarcinoma
- Gallbladder carcinoma
Cohorts 1E, 1F, 1G, and 2A
- Gastric adenocarcinoma
- GEJ adenocarcinoma
- Esophageal adenocarcinoma
Cohort 2B
- CRC
- Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.
- HER2+ disease, as determined by historic or local laboratory testing
- Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator
- Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Exclusion Criteria:
- History of known hypersensitivity to planned study treatment
- Known to be positive for Hepatitis B or C
- For Cohorts 2A and 2B: prior anti-HER2 therapies
- For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
There are additional inclusion criteria. The study center will determine if criteria for participations are met.
Sites / Locations
- Mayo Clinic Arizona
- Stanford Cancer Center / Blood and Marrow Transplant Program
- University of Colorado Hospital / University of Colorado
- SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
- Johns Hopkins Medical CenterRecruiting
- H. Lee Moffitt Cancer Center and Research Institute
- University of Chicago Medical Center
- Mayo Clinic Rochester
- Washington University in St LouisRecruiting
- New Mexico Cancer CenterRecruiting
- Levine Cancer InstituteRecruiting
- Duke University Medical Center
- Gabrail Cancer Center Research, LLC
- Cleveland Clinic, The
- Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of WashingtonRecruiting
- National Cancer Center Hospital
- National Cancer Center Hospital East
- St. Marianna University School of Medicine
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Aichi Cancer CenterRecruiting
- Kindai University Hospital
- Osaka International Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1A
Cohort 1B
Cohort 1C
Cohort 1D
Cohort 1E
Cohort 1F
Cohort 1G
Cohort 2A
Cohort 2B
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Tucatinib + trastuzumab + CAPOX given in 21-day cycles
Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days
Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles
Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.
Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.