Phase II Trial of Pulsed Dose Chemotherapy Plus Pembrolizumab in the First Line Treatment of Recurrent/Metastatic HNSCC
Dan Zandberg
Summary
The rationale for the new sequence of pulsed dose chemotherapy proposed in this trial is based on the hypotheses that current standard dosing of chemotherapy plus pembrolizumab ultimately suppresses the immune system and has a negative effect on the efficacy of the anti-PD-1 monoclonal antibody (mAb) therapy and that chemotherapy given after anti-PD-1 mAb therapy is associated with higher efficacy.
Description
Chemotherapy plus pembrolizumab plays a significant role in standard of care frontline treatment in R/M HNSCC and there is a need for improvement in outcomes with this combination therapy. This trial importantly will test a new dosing and sequence of pembrolizumab and chemotherapy, with the primary goal of improving efficacy but secondarily also has the potential to be better tolerated than standard dosing. Additionally, this trial may have applicability to other solid tumor types where chemotherapy and anti-PD-1 mAb are currently combined. Based on current data showing that current repetitive…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Recurrent/metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies. 2. PD-L1 Combined Positive Score (CPS) \>1 3. Age \> 18 years. 4. Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-2 5. Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1 6. Patients must have normal organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mcL 2. platelets ≥100,000/mcL 3. total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN) 4. AST(SGOT)/ALT(…
Interventions
- DrugPembrolizumab
Immunotherapy that works by helping the immune system to kill cancer cells by targeting and blocking a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
- DrugCarboplatin
A chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.
- DrugPaclitaxel
A chemotherapeutic agent used as a treatment for various cancers; paclitaxel is a mitotic inhibitor.
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania