Yervoy (ipilimumab)

During treatment with nivolumab, ipilimumab, cisplatin, and temozolomide, he developed multiple bluish macule-like lesions on the retroauricular region, neck, and anterior chest, surrounded by vitiligo-like halos. This case underscores the importance of biopsy for new pigmented lesions arising during melanoma immunotherapy. Recognizing tumoral melanosis is essential to avoid misinterpretation as disease progression and to guide appropriate clinical management.

Nivolumab plus ipilimumab is an effective and relatively well-tolerated option for MSI-H/dMMR CRC, offering significant clinical benefit across disease stages. Ongoing trials and longer follow-up are warranted to optimise dosing, identify predictive biomarkers, and refine patient selection.

Treatment with immune checkpoint inhibitors(ipilimumab plus nivolumab)was initiated. As of 4 years and 3 months post-surgery, tumor shrinkage has been sustained, with no evidence of new malignancies, recurrence, or metastasis. Given the presence of multiple colorectal cancers, a history of gynecologic malignancy, and a family history of gastrointestinal cancers, this case illustrates the importance of early consideration of hereditary tumors and highlights the clinical utility of genomic medicine.

P2, N=22, Active, not recruiting, Brown University | Trial completion date: Jul 2025 --> Jan 2026

P2, N=46, Not yet recruiting, The Second Affiliated Hospital of Dalian Medical University

P3, N=252, Recruiting, NRG Oncology | Not yet recruiting --> Recruiting

P2/3, N=600, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

P2, N=84, Active, not recruiting, Massachusetts General Hospital | Trial primary completion date: Jan 2026 --> Jan 2027

High myeloid and Treg signatures correlated with poor responses. We conclude that GVAX/CRS-207 plus nivolumab and ipilimumab successfully generates and expands T-cell clones specific to mesothelin and mutant KRAS within the PDAC TME but immunotherapy-induced myeloid-cell enrichment remains a barrier to greater efficacy.

These findings support the clinical development of ROSE12 as a tumor-selective Treg-depleting immunotherapy with potential efficacy in programmed cell death protein-1/PD-L1 therapy-resistant patients. The favorable safety profile was attributed to the ATP-dependent binding mechanism that restricts activity to the high-ATP tumor microenvironment. ROSE12 is currently being evaluated in phase I clinical trials (NCT05907980).

P2, N=24, Completed, M.D. Anderson Cancer Center | Trial primary completion date: Aug 2026 --> Aug 2025 | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Aug 2025

P2, N=5, Terminated, University Health Network, Toronto | Trial completion date: Nov 2025 --> Feb 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Feb 2025; Low accrual