Testing two medications together for advanced head and neck cancer

Plain-English translation of NCT06597565 on ClinicalTrials.gov ↗ · Source last updated October 2025 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a combination of two medications: prexasertib () and a low dose of in patients with head and neck cancer that has come back or spread. Researchers want to see how well this medication combination works and how safe it is. The study will also look at whether the cancer's specific characteristics affect how well the treatment works.

Head and neck cancer that returns or spreads is very difficult to treat, especially after patients have already tried immunotherapy. This trial is exploring whether combining these two medications in a new way might help patients whose cancer hasn't responded to standard treatments.

Do you qualify?

You likely qualify if…

you have been diagnosed with head and neck squamous cell carcinoma that has returned or spread to other parts of your body
you have already received at least one prior treatment with an immunotherapy drug (PD-1 or PD-L1 inhibitor), or you are unable to receive immunotherapy due to an autoimmune condition
you have at least one measurable tumor lesion that can be seen on imaging scans
you are in good enough health to tolerate treatment, with an Eastern Cooperative Oncology Group performance status of 0 or 1
you have tumor tissue available for testing, or you are willing to have a biopsy to provide fresh tissue
you are willing to use effective birth control for 1 year if you or your partner could become pregnant

You likely don't qualify if…

you have received other systemic cancer treatment within the past 4 weeks
you have received palliative radiation therapy within the past 2 weeks (unless it doesn't involve the tumors being measured)
you have ongoing side effects from prior cancer treatments that are Grade 2 or higher in severity
you are pregnant or breastfeeding

What participation looks like

You would receive the medication combination through an IV infusion every 2 weeks, organized in 4-week treatment cycles. Before your first cycle, you'll receive a single lead-in dose of one medication. You'll continue treatment unless your cancer worsens, you experience intolerable side effects, or you choose to withdraw. You'll also need to have biopsies (small tissue samples taken) after the lead-in dose and if your cancer progresses, so researchers can understand how the treatment is affecting your tumor at a cellular level.

AI-generated summary from trial data · Jul 18, 2026 · Not medical advice

Trial locations(1 site)

United States

Moffitt Cancer Center, Tampa, Florida