What the trial was testing
The trial enrolled 48 patients with melanoma. The study was sponsored by Inge Marie Svane and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. 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
80% tumor response rate, including 43% complete responses.
Nature Medicine · 2021 · NCT03047928
These findings — that in untreated metastatic melanoma on the IDO/PD-L1 vaccine plus nivolumab — were published in the Nature Medicine and represent the headline result of the study.
Researchers tracked outcomes across 48 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
The IO102/IO103 vaccine is still in development and not yet FDA-approved. Nivolumab (Opdivo) alone or with ipilimumab (Yervoy) is FDA-approved and available now for metastatic melanoma. Other newer combinations like nivolumab + relatlimab (Opdualag) are also approved. Ask an oncologist about approved options or trials.
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
Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically
The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.