What the trial was testing
The trial enrolled 94 patients with melanoma. The study was sponsored by National Cancer Institute (NCI) and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The combination therapy resulted in tumor shrinkage in 28% of patients whose cancer had previously resisted treatment.
Nature medicine · 2023 · NCT03033576
These findings — that patients saw their tumors shrink with the combination versus 9% with single treatment — were published in the Nature medicine and represent the headline result of the study.
Researchers tracked outcomes across 94 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with melanoma, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study in patients whose melanoma stopped responding to initial immunotherapy. Both nivolumab and ipilimumab are already FDA-approved for melanoma, though this specific combination approach for treatment-resistant cases may require discussion with your oncologist about whether it's appropriate for your situation.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open melanoma trials
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.
Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases
To evaluate tumor response, survival and adverse effects after precision radiotherapy (SBRT) in melanoma patients with ongoing PD-1 inhibitor treatment that have tumor progression.