Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2027-05-02
Target enrollment:
Participant gender:
Summary
Participants in this study have a type of cancer called squamous cell carcinoma of the head
and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This
is called locally-advanced SCCHN. These participants are eligible for surgery.
Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage,
high rates of avoiding radiation and its side effects, high cure rate and good quality of
life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If
the participants are not on this study they would be receiving radiation as it is standard
treatment of their cancer. In the last study with a similar regimen, about a third of cancers
had a pathologic complete response with the first part of the study. This means that the
chemotherapy had killed the cancer. The investigators are trying to improve the regimen
further with a goal of increasing this rate of complete response to the first part of
therapy. The investigators also hope that by improving results in the first part, that more
people will be cured and that long term quality of life (especially speech and swallowing)
will be improved, both compared to standard therapies and to the last study. Doctors do not
know how this therapy will effect the participants. There is no guarantee that this study
will benefit the participants.
The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and
a third targeted anti-cancer drug. In this study the investigators are testing the
combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound
paclitaxel has been shown to be more active against other types of squamous cancers than
regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head
and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to
fight the cancer. Doctors hope that combining Durvalumab with 2 chemotherapy drugs will be
effective in treating SCCHN. Durvalumab on its own has been studied in patients with SCCHN
and initial results have shown that some subjects' cancer has responded to it.
The purpose of this study is to test a combination of chemotherapy to hopefully both increase
the number of subjects that respond to therapy while also decreasing the number of side
effects that subjects experience.