Opdivo (nivolumab)

P3, N=790, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Jun 2027 --> Nov 2026

P=N/A, N=726, Active, not recruiting, Bristol-Myers Squibb

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.

P2, N=52, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2027 --> May 2028 | Trial primary completion date: Dec 2026 --> Dec 2027

P1, N=0, Withdrawn, Case Comprehensive Cancer Center | N=15 --> 0 | Not yet recruiting --> Withdrawn

P2, N=140, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028

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.

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

Immunotherapy has transformed oral squamous cell carcinoma management, with programmed cell death protein-1 inhibitors like nivolumab and pembrolizumab showing survival benefits in trials, particularly in programmed cell death protein-L1-positive cases. Future priorities include biomarker validation via prospective registries, scalable Good Manufacturing Practice nanoplatforms, AI-driven multi-omic modeling, and federated learning for predictive analytics. By integrating tumour genomics, immune profiling, and advanced delivery, precision immuno-oncology holds promise to improve response rates, durability, and quality of life in oral squamous cell carcinoma.