Opdivo (nivolumab)

P2, N=15, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Nov 2026

P1/2, N=24, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed

P1, N=27, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2025 --> Jun 2027 | Trial primary completion date: Aug 2025 --> Jun 2027

P=N/A, N=50, Recruiting, Asan Medical Center | Trial primary completion date: Aug 2025 --> Aug 2026 | Not yet recruiting --> Recruiting | Phase classification: P2 --> PN/A | Trial completion date: Aug 2025 --> Aug 2026

P2, N=10, Terminated, M.D. Anderson Cancer Center | Trial completion date: Jul 2027 --> Nov 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2027 --> Nov 2025; The study met its prespecified futility criteria during the prespecified interim futility analysis after enrolling the first cohort of 10 patients.

Individual patient data (IPD) from the KEYNOTE-177 and CheckMate-8HW trials were collected with IPDfromKM and used to develop a Markov model with a 30-year duration and three mutually exclusive health states, providing a framework for the evaluation of the cost-effectiveness of first-line nivolumab together with ipilimumab, pembrolizumab, and chemotherapy for treating MSI-H/dMMR advanced CRC. In addition, the established model is stable. First-line immunotherapeutic treatments for MSI-H/dMMR advanced CRC cases in the USA appears to be cost-effective, with a dual-immunotherapeutic regimen consisting of nivolumab plus ipilimumab being preferable.

We analyzed outcomes in AGC patients with CPS 1-4 who received nivolumab in combination with capecitabine and oxaliplatin (XELOX) or fluorouracil, oxaliplatin, and leucovorin (FOLFOX) as first-line therapy between April 2021 and December 2024. This real-world retrospective study suggests modest efficacy of AGC patients with low CPS treated with nivolumab with chemotherapy. Further studies are needed to determine the optimal treatment strategy and to identify predictive biomarkers for therapy selection in patients with low-CPS AGC.

P=N/A, N=232, Completed, Ankara Etlik City Hospital

Co-expression of PD1 and PD-L1 may play a role in regulating proliferation of tumor cells, particularly in cases with strong PD1 expression on tumor cells.

In the INCREASE trial, neoadjuvant IPI/NIVO combined with CRT for patients with T3-4N0-2 NSCLC elicited enhanced immune responses in TDLN despite exposure to high dose radiation. Even though radiation-induced fibrosis was evident in high dose TDLN, the immune responses were not diminished when compared with low dose TDLN. These findings underscore the resilience of TDLN immunological function under intense radiation exposure.

Our findings indicate that rela/nivo may remain active following anti-PD-1 or ipi/nivo therapy. Additionally, our results suggest that sequencing ipi/nivo before rela/nivo may yield better outcomes than starting with rela/nivo. Patients who respond to the first combination regimen appear to derive greater benefit from the second. Further efforts are needed to optimize sequencing strategies in advanced melanoma, and future studies should consider the impact of prior treatment outcomes.

P1, N=32, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Oct 2025 --> Jan 2026