Malignancy | ClinicalTrials.gov ID | Characteristics | Key inclusion and exclusion criteria | Relevant study procedures | Ref. |
NSCLC | NCT03520634 | N=13 7 male Median age 63 (58–69) | Inclusion: advanced NSCLC, EGFR wild type and EML4-ALK fusion-negative, ECOG 0–1. Exclusion: symptomatic central nervous system metastases, use of corticosteroids,* interstitial lung disease or active infection. | Baseline: 18F-BMS-986192 PET/CT scans (N=13). On-treatment: not performed. Injected activity: 1.5–3.0 MBq/kg. Treatment: nivolumab 3 mg/kg, Q2W. Response evaluation: RECIST V.1.1 at 12 weeks. | 11 |
Melanoma | NCT03520634 | N=8 5 male Median age 62 | Inclusion: stage IV metastatic melanoma, ECOG 0–1. Exclusion: autoimmune disease, treatment with immunosuppressive medication. | Baseline: 18F-BMS-986192 PET/CT scans (N=8). On-treatment: 18F-BMS-986192 PET/CT scans at 6 weeks (N=4). Injected activity: 185 MBq. Treatment: nivolumab (3 mg/kg) with (N=5) or without (N=3) ipilimumab (1 mg/kg), Q3W. Response evaluation: RECIST V.1.1 at 12 weeks. | 12 |
OCSCC | NCT03843515 | N=16 11 male Median age 72 (49–86) | Inclusion: stage III/IV resectable OCSCC, ECOG 0–1. Exclusion: secondary malignancy, use of corticosteroids,* interstitial lung disease or active infection. | Baseline: 18F-BMS-986192 PET/CT scans (N=16). On-treatment: 18F-BMS-986192 PET/CT scans at 3 weeks (N=14). Injected activity: 216 MBq (range 167–246). Treatment: nivolumab (single flat dose 480 mg). Response evaluation: pathological response. | Preliminary data,15 manuscript in preparation |
PDAC | NCT01939665 | N=11 5 male Median age 63 (43–75) | Inclusion: stage IV metastatic PDAC, max. five metastases of ≥1 cm, stable disease after FOLFIRINOX treatment, WHO 0–2. Exclusion: brain metastases, active autoimmune disease requiring corticosteroids* active infections, prior immunotherapy, secondary malignancy. | Baseline: 18F-BMS-986192 PET/CT scans (N=11). On-treatment: 18F-BMS-986192 PET/CT scans at 6± weeks (N=5). Injected activity: 3.0 MBq/kg (range 2.3–3.6). Treatment: nivolumab (cycle 1 and 2,240 mg, from cycle 2 and onwards 480 mg Q4W). Induction therapy with either (nivolumab 240 mg (N=3), IRE (N=3), or IRE and intratumoral CpG injection (N=3). Response evaluation: RECIST V.1.1 at 6 weeks, every 3 months. | Protocol,16 manuscript in preparation |
*10 mg prednisone equivalent or more.
CpG, cytosine-phosphate-guanine motifs, a toll-like receptor ligand; CTLA-4, cytotoxic T-lymphocyte associated protein 4; ECOG, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EML4-ALK, echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase; IRE, irreversible electroporation; irPC, immune-related pathological response criteria; NSCLC, non-small cell lung cancer; OCSCC, oral cavity squamous cell carcinoma; PD-1, programmed death 1; PDAC, pancreatic adenocarcinoma; PD-L1, programmed death ligand 1; PET, positron emission tomography; Q2W, 2 weekly dosing; Q3W, 3 weekly dosing; RECIST, response evaluation criteria in solid tumors; WHO, WHO performance status.