Improved outcomes were associated with lower levels of N-(3-Indolylacetyl)-L-alanine in patients with stage IIIB-IV NSCLC lacking driver gene mutations, who underwent first-line or second-line therapy with PD-1 inhibitors combined with chemotherapy. Further exploration of the potential predictive value of pretreatment detection of N-(3-Indolylacetyl)-L-alanine in peripheral blood for the efficacy of combination therapy is warranted.

P2, N=25, Not yet recruiting, Mayo Clinic

P2, N=140, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026

P1, N=78, Active, not recruiting, Symphogen A/S | N=148 --> 78 | Trial completion date: Jan 2025 --> Jun 2024

P2, N=60, Active, not recruiting, Xiao X. Wei, MD | Recruiting --> Active, not recruiting

P2, N=27, Enrolling by invitation, Sun Yat-sen University | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Sep 2023 --> Apr 2024

P1, N=48, Active, not recruiting, Symphogen A/S | N=100 --> 48

PFS24 was associated with presence of MEGF8 or SETD1B somatic mutations. This trial met its co-primary endpoints (ORR and PFS24) early, and our findings highlight several genetic and tumor microenvironment parameters associated with response to PD-1 blockade in dMMR cancers, generating rationale for their validation in larger cohorts.ClinicalTrials.gov identifier: NCT03241745 .

No abstract available

Nivolumab plus chemotherapy in the first-line setting has demonstrated clinical efficacy in patients with human epidermal growth factor receptor 2-negative advanced or metastatic gastric cancer, and is currently indicated as a standard treatment...In this review, we present cases of gastric cancer with consensus PD-L1 CPS. In addition, we briefly touch upon current practices and clinical issues associated with assays used for the assessment of PD-L1 expression in gastric cancer.

P3, N=1050, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2030 --> Sep 2029

Patients without cytoreductive nephrectomy and with bone metastasis, liver metastasis, high C-reactive protein levels and paraneoplastic symptoms were significantly correlated with shorter progression-free survival. The presence of paraneoplastic symptoms was an independent predictor of progression-free survival. Improvement in paraneoplastic symptoms may reflect the treatment efficacy of nivolumab plus ipilimumab.

In conclusion, sPD-L1 measured in baseline serum samples may be associated with OS in NSCLC patients receiving anti-PD1/anti-PD-L1 treatment. Importantly, the results signify that further research is warranted to explore the clinical utility of sPD-L1 in patients treated with anti-PD-L1.

This is a single-arm, phase II trial (NCT04026841) using Simon's optimal two-stage design, of which 4 doses of sintilimab (200 mg per 3 weeks) were administrated in 36 enrolled multiple primary lung cancer (MPLC) patients with persistent high-risk (Lung-RADS category 4 or had progressed within 6 months) GGOs...Collectively, PD-1 inhibitor showed certain activity on high-risk pulmonary GGO lesions without safety concerns. Such effects were associated with specific T-cell re-distribution, EGF/CTLA-4 cytokine compensation, and regulation of metabolism pathways.

P1, N=22, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | N=98 --> 22

P4, N=50, Recruiting, Samsung Medical Center | Trial completion date: Aug 2023 --> Aug 2024

P2, N=30, Completed, Shanghai Changzheng Hospital | Recruiting --> Completed | Trial primary completion date: Dec 2023 --> Sep 2023

P2, N=25, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Apr 2024

P=N/A, N=20, Recruiting, RenJi Hospital

P2, N=80, Completed, Johannes Laengle, MD, PhD | Recruiting --> Completed | Trial completion date: Dec 2024 --> Mar 2024 | Trial primary completion date: Jun 2024 --> Mar 2024

P2, N=264, Active, not recruiting, Sun Yat-sen University | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

P1/2, N=179, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P2, N=138, Active, not recruiting, University of Texas Southwestern Medical Center | Recruiting --> Active, not recruiting

P2, N=80, Active, not recruiting, Peking Union Medical College Hospital | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2027

PD-L1 assays by 28-8 and 22C3 showed suboptimal concordance, while inter-observer variability was not critical in advanced gastric cancer. Discordant PD-L1 results between 28-8 and 22C3 assays may be associated with unfavorable efficacy outcomes in patients treated with nivolumab plus chemotherapy.

The mean overall survival and the progression-free survival were 45.8 and 17.1 months for the low PERLS group (n = 39), compared with 29.9 (P = 0.001) and 9.7 (P = 0.003) months for the high PERLS group (n = 20), respectively. Pretreatment PERLS might contribute to selecting patients before receiving anti-PD-1 therapy.

P1, N=3, Recruiting, H. Lee Moffitt Cancer Center and Research Institute

P1, N=12, Not yet recruiting, University Health Network, Toronto

P2, N=71, Recruiting, Memorial Sloan Kettering Cancer Center

P1, N=33, Not yet recruiting, Washington University School of Medicine | Trial completion date: Mar 2030 --> Jun 2030 | Trial primary completion date: Jun 2028 --> Sep 2028

P1, N=12, Completed, University of Chicago | Recruiting --> Completed | N=26 --> 12

P2, N=28, Not yet recruiting, Masonic Cancer Center, University of Minnesota

There was no obvious cancerous remnant in the resected specimen, and the pathological response was Grade 3. The patient was alive and recurrence-free at 4 months postoperatively.

On the other hand, there are some approved drugs, such as pembrolizumab for TMB-H or entrectinib or larotrectinib for NTRK fusion gene, for which there is no stand-alone companion diagnostics and the eligibility for these drugs cannot be judged without the results of CGP test. This paper discusses the current status and issues of companion diagnostics in cancer genomic medicine.

CASE REPORT We report a rare case of grade 3 CRS induced by nivolumab associated with 5-fluorouracil and oxaliplatin for gastric cancer...There was rapid resolution after infusion of hydrocortisone...Nivolumab-induced CRS is rarely described but can be severe and lead to multiple organ dysfunction; therefore, intensive care practitioners should be informed about this adverse effect. More studies are needed to better understand this condition and establish treatment guidelines.

P3; With ∼5 years of follow-up, pembrolizumab plus chemotherapy provided clinically meaningful and durable improvements in survival outcomes versus chemotherapy alone in patients with previously untreated metastatic NSCLC with PD-L1 TPS <1%. These results continue to support pembrolizumab plus chemotherapy as a standard of care in this patient population.

Here, we report a case of an 89-year-old patient with metastatic melanoma to the liver, lung and lymph nodes, who underwent treatment with Opdualag (combining anti-PD-1 nivolumab and anti-lymphocyte-activation gene 3 relatlimab ICBs), and developed pseudoprogression after two cycles of therapy. The patient experienced a radiographic increase in liver metastatic lesion size, but was found to have a subsequent reduction in these lesions. The patient has been on therapy for 18 months without evidence of disease progression and continues to be clinically well-appearing.

He has achieved a progression-free survival of 43 months and is still being followed up at our center. The above results suggest that this therapeutic regimen is a promising treatment modality for the management of pretreated, MSS-type and KRAS-mutated metastatic colorectal cancer although its application to the general public still needs to be validated in clinical trials.

Nab-paclitaxel plus sintilimab is a potentially effective and tolerable second-line regimen for advanced BTC that deserves to be studied in large-scale trials. PD-L1 status and CD8+ T cell infiltration might be promising biomarkers for efficacy prediction.

P2, N=60, Not yet recruiting, Beijing Chest Hospital, Capital Medical University

P1, N=18, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting

P2, N=78, Active, not recruiting, Patrick Boland | Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Mar 2024