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There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC. There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype metastatic CRC.
Full description
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Pembrolizumab will be infused prior to the start of the assigned monoclonal antibody (Mab) arm. .
Dosing for the Mab arms will begin as follows:
Arm 1: Cycle length is 21 days. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.
Arm 2: Cycle length is 21 days. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.
Arm 3: Cycle length is 21 days. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.
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Inclusion criteria
Patient has definitive histologically or cytologically confirmed unresectable or metastatic solid tumor.
Patient has one or more tumor measurable as defined by RECIST 1.1 by CT scan (or PET/CT, if patient is allergic to CT contrast media).
Patients can be enrolled only on one of the treatment arms on this trial.
The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance to a specific Mab and then enrolled on an arm with that same Mab plus pembro, (b) The Mab on the arm selected must be considered standard of care or listed in the NCCN guidelines (www.nccn.org) for that cancer type. For Arm 1, patients with HER2 overexpressing MBC eligible for maintenance trastuzumab are allowed after taxane plus trastuzumab plus pertuzumab combination therapy.
Have recovered from acute toxicities of prior treatment:
Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening:
Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 9 g/dL.
Serum creatinine ≤2.0, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal (ULN) range
Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the upper limit of normal range, then a free T4 within institutional normal limits is acceptable.
Persistent prior systemic therapy non-hematologic AE grade ≥ 2 (except alopecia or correctable electrolyte abnormality with supplementation)
Patient has a Karnofsky performance status (KPS) ≥ 70.
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
Inclusion criteria for Phase II only:
Exclusion criteria
Exclusion Criteria for phase II portion only:
Primary purpose
Allocation
Interventional model
Masking
16 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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