Opdivo (nivolumab)

P1, N=21, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Apr 2026

P1, N=14, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2028 --> Dec 2026

P1, N=57, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting

She started combination therapy with ipilimumab and nivolumab, achieving complete metabolic and imaging response as confirmed by PET-CT at 12 months...She started treatment with pembrolizumab, achieving a sustained complete response at 12 months...Both cases illustrate the remarkable clinical benefit of immunotherapy in patients with early peritoneal recurrence of MSI-H/dMMR colon cancer, which is usually associated with poor prognosis. These cases highlight the need to consider the molecular profile in therapeutic planning and reinforce the emerging value of immunotherapy as a cornerstone in the management of these cases.

P2/3, N=690, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting

These findings warrant further trials on IT nivolumab.

Most trials focused on Stage III/IV patients (91.1%): key trials showed mRNA-4157 + pembrolizumab reduced recurrence/death risk by 49% in resected melanoma, and herpes simplex virus RP1 + nivolumab achieved 58.3% objective response rate (ORR) in ICI-resistant patients. However, challenges include tumor heterogeneity, immunosuppressive tumor microenvironment (TME), inefficient delivery, geographical R&D imbalance, and low Phase III conversion. Interdisciplinary collaboration, international multicenter trials, optimized clinical design (e.g., early-stage patient enrollment), and policy support are needed to advance their clinical translation.

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.

Currently, pembrolizumab plus or less chemotherapy is recommended in patients with CPS > 1 in metastatic HNSCC, while nivolumab is used in the second line setting for platinum-refractory disease. This review discusses both completed and ongoing clinical trials with PD-1/PDL-1 and new checkpoint inhibitors and immunotherapies. It also addresses mechanisms of resistance to immunotherapy, potential therapeutic strategies to overcome this resistance, biomarkers and side effects.

P1, N=57, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027

P1, N=65, Active, not recruiting, Genentech, Inc. | Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Dec 2025 --> Jun 2027

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