Yervoy (ipilimumab)

P3, N=626, Active, not recruiting, Ono Pharmaceutical Co., Ltd. | Trial primary completion date: May 2026 --> Oct 2025

P2, N=80, Active, not recruiting, Dan Zandberg | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Jul 2026 --> Oct 2027

In 2025, Australia's Pharmaceutical Benefits Advisory Committee adopted a novel broad cancer listing on the Pharmaceutical Benefits Schedule for nivolumab, ipilimumab and pembrolizumab. We suggest that while a broad listing represents a pragmatic response to the growing prevalence of multi-indication medicines, it entails important trade-offs between access, transparency and value alignment. These design considerations are likely to be relevant for other jurisdictions considering similar reimbursement reforms.

In this single-arm, phase I study (NCT04117087), we evaluated mKRAS-VAX, a pooled mutant KRAS (mKRAS) peptide vaccine targeting six KRAS mutations with nivolumab and ipilimumab in 13 patients with pretreated metastatic MMRp/MSS CRC. mKRAS-VAX elicited an increase in tumor-specific mKRAS-reactive T-cells in 8/12 biomarker-evaluable patients (75%) by direct ex vivo IFNγ ELISpot and in 12 patients (100%) following in vitro expansion. Our findings support further development of mKRAS vaccines with ICIs for advanced MMRp/MSS CRC.

The present study aimed to investigate the therapeutic efficacy and underlying mechanism of olive oil-based lipid emulsions (OOLE) in mitigating immune checkpoint inhibitor (ICI)-induced myocarditis triggered by ipilimumab (IPI) and nivolumab (NIVO). In conclusion, OOLE mitigates acute ICI-induced myocarditis by targeting the NF-κB/NLRP3/IL-1β pathway, demonstrating its potential in suppressing early inflammatory cascades and providing rapid cardioprotection. These findings highlight its promise as an adjunctive therapy for immune-related cardiac injury.

This case highlights the use of immunotherapy and screening for pediatric CMMRD-associated colorectal adenocarcinoma in the setting of a novel PMS2 variant.

The addition of ipilimumab to atezolizumab plus bevacizumab did not show any benefit in patients with previously untreated, unresectable hepatocellular carcinoma. These results do not support the addition of low-dose (1 mg/kg) ipilimumab to atezolizumab plus bevacizumab as a first-line treatment in this setting.

P2, N=113, Active, not recruiting, National Cancer Centre, Singapore | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Apr 2027 | Trial primary completion date: Dec 2024 --> Apr 2027

In contrast, the same regimen showed inferior OS relative to many comparators (HR range for comparators vs. toripalimab plus chemotherapy: 0.47-0.65) and had the lowest OS ranking in SQ-NSCLC (SUCRA = 0.09). In the PD-L1 < 1% subgroup, nivolumab plus ipilimumab demonstrated a trend toward better OS compared with pembrolizumab plus chemotherapy (HR = 0.59) and ranked as the best regimen for SQ-NSCLC (SUCRA = 0.83), whereas pembrolizumab plus chemotherapy provided the greatest OS benefit for non-SQ-NSCLC (SUCRA = 0.90). In the PD-L1 ≥ 50% subgroup, atezolizumab plus chemotherapy ranked second for OS benefit in SQ-NSCLC but was the least effective combination in non-SQ-NSCLC; conversely, cemiplimab plus chemotherapy was the least effective combination in SQ-NSCLC but ranked second in non-SQ-NSCLC. The efficacy of individual first-line ICI regimens appear to vary by histological subtype across PD-L1 expression levels. These findings suggest that PD-L1 status alone might not be sufficient to guide treatment selection, and that histological subtype could be considered in clinical decision-making for advanced NSCLC.

Postoperatively, nivolumab + ipilimumab with radiotherapy achieved disease control. In this hypothesis-generating case report, TP53, NF2, and KMT2A secondary alterations on an FH-null background were associated with lineage infidelity, which can create diagnostic challenges that underscores the role for integrated pre‑ and post‑treatment multi‑omics in diagnostically ambiguous renal tumors.

These findings indicate that inherited genetic background contributes to thyroid immune toxicity risk following ICI and support PRS-based approaches for risk-adapted monitoring during immunotherapy.

P=N/A, N=20, Suspended, M.D. Anderson Cancer Center