Investigational Drug
Cetrelimab
TrialFetch AI Analysis
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Overview
Cetrelimab (JNJ-63723283) is an investigational, intravenously administered IgG4 monoclonal antibody being studied in solid tumors, particularly urothelial carcinoma. Clinical activity has been observed both as monotherapy and in combinations, but efficacy varies by tumor type and no approved indication has been established. (pmc.ncbi.nlm.nih.gov)
Mechanism of action
Cetrelimab binds programmed cell death protein 1 (PD-1), blocking this immune-checkpoint receptor and thereby restoring antitumor T-cell activity. In the first-in-human study, sustained PD-1 inhibition was demonstrated throughout the dosing interval. Recommended phase II regimens were 240 mg every two weeks or 480 mg every four weeks. (pmc.ncbi.nlm.nih.gov)
Efficacy
In the phase I/II LUC1001 study of 204 patients with advanced solid tumors, the overall response rate (ORR) was 18.6%, including 6 complete and 32 partial responses. ORRs were 34.3% in non-small-cell lung cancer, 52.6% in PD-L1-high NSCLC, 28.0% in melanoma, and 23.8% in centrally confirmed MSI-high colorectal cancer. Median progression-free and overall survival across tumor types were 2.8 and 17.8 months, respectively; these nonrandomized results should be interpreted as preliminary. (pmc.ncbi.nlm.nih.gov)
In BCG-unresponsive high-risk non–muscle-invasive bladder cancer, cetrelimab monotherapy produced a centrally assessed complete-response rate of 46% in 28 patients in SunRISe-1; the estimated 12-month complete-response rate was 23%. The combination with an intravesical gemcitabine-releasing system produced a 68% complete-response rate, although this was not a controlled comparison. (annalsofoncology.org)
In the randomized phase II NORSE study of first-line, cisplatin-ineligible metastatic urothelial carcinoma with FGFR alterations, erdafitinib plus cetrelimab achieved an ORR of 54.5%, including 13.6% complete responses, versus 44.2% with erdafitinib alone. Median overall survival was 20.8 versus 16.2 months, but the trial was not designed for formal statistical comparison. (ascopubs.org)
In contrast, the phase III SunRISe-2 trial did not demonstrate superiority of intravesical gemcitabine plus cetrelimab over chemoradiotherapy in muscle-invasive bladder cancer. The 24-month bladder-intact event-free survival rates were 58.5% versus 66.5%, respectively (hazard ratio 1.71). (ascopubs.org)
Safety
In LUC1001, grade 3 or higher adverse events occurred in 53.9% of patients; immune-related adverse events occurred in 35.3%, including grade 3 or higher events in 6.9%. (pmc.ncbi.nlm.nih.gov)
In SunRISe-1, treatment-related grade 3 or higher adverse events occurred in 7% with cetrelimab monotherapy and 36% with the intravesical gemcitabine combination; no treatment-related deaths were reported. In NORSE, grade 3 or higher treatment-related events occurred in 45.5% with erdafitinib plus cetrelimab, with hyperphosphatemia, stomatitis and dry mouth among the most frequent events. (annalsofoncology.org)
Further reading
- First-in-human phase I/II cetrelimab study
- Final phase II NORSE results
- Updated SunRISe-1 results
- Phase III SunRISe-2 final results
Last updated: Sep 2026
Active trials using Cetrelimab
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC and ECOG 0–1 receive intratumoral tolododekin alfa (ANK-101), a tumor-retained IL-12 formulation intended to stimulate T-cell and natural killer cell activity. Patients whose disease progressed after PD-1/PD-L1 blockade and platinum chemotherapy also receive investigational anti-PD-1 antibody cetrelimab; those untreated for advanced disease receive an investigator-selected approved anti-PD-1/PD-L1 antibody.
ClinicalTrials.gov ID: NCT07027514
TrialFetch AI summary: Adults with stage IIIB–IV NSCLC are eligible, with prior-treatment requirements varying by cohort; combination cohorts exclude targetable mutations. Treatment is oral JNJ-86974680, an adenosine A2A receptor antagonist, alone or with the anti-PD-1 antibody cetrelimab, with radiotherapy added in the combination cohorts.
ClinicalTrials.gov ID: NCT06116786
TrialFetch AI summary: Adults with metastatic prostate adenocarcinoma and ECOG 0–1 are eligible; most cohorts require castration-resistant disease and prior androgen receptor pathway inhibitor treatment, while a separate apalutamide cohort enrolls patients with hormone-sensitive disease. The study combines pasritamig, an investigational KLK2×CD3 bispecific antibody that redirects T cells to prostate cancer cells, with the investigational PD-1 inhibitor cetrelimab, a taxane, or an androgen receptor pathway therapy.
ClinicalTrials.gov ID: NCT05818683
