Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
BO-112 Plus Pembrolizumab for Patients With Anti-PD-1-Resistant Advanced Melanoma: Phase II Clinical Trial SPOTLIGHT-203.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04570332 (Phase 2 Single Arm Clinical Study to Evaluate the Efficacy and Safety of Intratumoral Administration of BO-112 in Combination With Pembrolizumab in Subjects That Have Progressed on Anti-PD-1-based Therapy for Stage III or IV Melanoma), which is not on this map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 2 Single Arm Clinical Study to Evaluate the Efficacy and Safety of Intratumoral Administration of BO-112 in Combination With Pembrolizumab in Subjects That Have Progressed on Anti-PD-1-based Therapy for Stage III or IV Melanoma
Who cites it
12 citing papers in PubMed.
- Real-World Outcomes of Nivolumab and Ipilimumab in Metastatic Melanoma as Third Line and Beyond.International journal of cancer · 2026Article
- Tumour-associated dsRNA accumulation and innate immune activation: mechanistic basis and therapeutic strategies.EBioMedicine · 2026Review
- A poly(I:C)/QS-21-based in situ vaccine synergizes with anti-PD-1 therapy to overcome tumor immunoresistance.Cell reports. Medicine · 2026Article
- Review
- Combinatorial in situ cancer vaccines: unlocking broad and enhanced antitumor responses.Signal transduction and targeted therapy · 2026Review
- Updates on intratumoral therapies in melanoma.Cancer · 2026Review
- Advanced Mucosal Melanoma Therapies: Current Status and Future Directions.Current treatment options in oncology · 2026Review
- RNA Regulatory Networks: Key Hubs in the Panorama of Cancer and Emerging Therapeutic Targets.MedComm · 2026Review
- Nanomaterial-based strategies overcome PD-1 related intrinsic immune resistance.Cancer drug resistance (Alhambra, Calif.) · 2026Review
- Review
- Toll-like receptors in innate immunity and inflammation: from fundamental biology to clinic insights.Immunity & inflammation · 2026Review
- Tumor-associated macrophages in cancer: from mechanisms to application.Molecular biomedicine · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
29 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePatients with anti-PD-1-resistant melanoma (MEL) have no well-defined standard of care. BO-112 is a synthetic, double-stranded RNA (poly I:C) nanoplexed with polyethylenimine that when administered intratumorally has showed in patients with solid tumors potential to revert this resistance. We report efficacy and safety of the phase II clinical trial of intratumoral BO-112 plus intravenous pembrolizumab for patients with anti-PD-1-resistant MEL (ClinicalTrials.gov identifier: NCT04570332).
methodsForty-two patients were treated with intratumoral BO-112 once every week for 7 weeks and then once every 3 weeks (up to 2 mg and up to eight lesions per treatment) combined with 200 mg pembrolizumab once every 3 weeks until progressive disease, unacceptable toxicity, death, or up to 1 year. Primary end point was RECIST 1.1 objective response rate (ORR) by independent central radiology review in modified intention-to-treat population (mITT; patients evaluable for response) with 20% ORR positivity threshold. Secondary key end points were progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety.
resultsFor mITT, there were 40 patients and the ORR was 25%, with 10% complete, 15% partial, and 40% stable disease, with nonachieved (NA) median DOR (95% CI, 8.3 to NA). For ITT, there were 42 patients, and the median PFS and OS were 3.7 months (95% CI, 2.2 to 9.2) and NA (95% CI, 9.9 to NA), respectively, with 54% patients alive at 24 months. The combination was well tolerated: 16 patients (38.1%) experiencing ≥G3-4 adverse events, four (9.5%) drug-related, and no deaths related to treatment.
conclusionThe clinical trial has met its primary end point (ORR) making BO-112 with pembrolizumab a potential strategy to revert anti-PD-1 resistance in patients with MEL. PFS results are in line with other clinical trials in anti-PD-1-resistant scenario, with promising OS data.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.