Yervoy (ipilimumab)

Despite first-line carboplatin, nab-paclitaxel, and pembrolizumab followed by second-line carboplatin, pemetrexed, nivolumab, and ipilimumab, the disease progressed rapidly, and the patient died four months after diagnosis. This case illustrates that isolated PIK3CA-mutant NSCLC can be highly refractory to conventional chemoimmunotherapy, including regimens incorporating a cytotoxic T-lymphocyte-associated antigen 4 inhibitor. Further clinical investigation of PI3K-targeted therapies is warranted to establish effective treatment strategies for PIK3CA-mutant NSCLC.

P3, N=718, Not yet recruiting, SWOG Cancer Research Network

P1/2, N=38, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Mar 2027 | Trial primary completion date: Jan 2026 --> Mar 2027

Among cisplatin-ineligible patients with MIBC, nivolumab alone was well tolerated. Ipilimumab/nivolumab caused toxicity that delayed cystectomy. Cases of progression before cystectomy indicated insufficient efficacy of pure neoadjuvant immunotherapy for unselected patients. Despite low response rates, some patients experienced sustained clinical CRs without cystectomy.

P2, N=120, Suspended, Michael B. Atkins, MD | Trial completion date: Oct 2026 --> Nov 2027 | Recruiting --> Suspended | Trial primary completion date: Jan 2026 --> Nov 2026

NIC and PC seem to be equally supportable options in the treatment of advanced NSCLC. Further analyses are needed to validate our findings.

REVOLUTION cohorts A and B demonstrated encouraging antitumor activity in patients with mPDAC. In cohort B, hydroxychloroquine-related tolerability issues contributed to early discontinuations and reduced drug exposure. These findings highlight the potential and limitations of current chemoimmunotherapy approaches. Although neither cohort will be expanded, the results reinforce the continued promise of chemoimmunotherapy in mPDAC and the importance of refining these strategies.

P2, N=29, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Mar 2026 --> Jul 2026

This was an open-label, Phase II, investigator-initiated exploratory study of patients with newly diagnosed GBM who completed maximal tumor resection and concurrent chemoradiation followed by standard adjuvant temozolomide and the combination of Nivolumab and Ipilimumab. Across each of the 4 individual immune measurements, no statistical difference in OS were observed between reactive and suppressed groups. In this limited cohort, no detectable difference in the OS was observed between patients with a reactive immune signature and those with a suppressed immune signature.

P2, N=30, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Dec 2025 --> Dec 2026

Our findings demonstrate favorable long-term outcomes for patients with an MPR and identify IFNγ and PD-L1 as promising baseline biomarkers. ClinicalTrials.gov identifier: NCT02977052 .

P1, N=33, Not yet recruiting, City of Hope Medical Center | Initiation date: Dec 2025 --> Apr 2026