Table 1

Overview of included 18F-BMS-986192 imaging studies

MalignancyClinicalTrials.gov IDCharacteristicsKey inclusion and exclusion criteriaRelevant study proceduresRef.
NSCLCNCT03520634N=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
MelanomaNCT03520634N=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
OCSCCNCT03843515N=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
PDACNCT01939665N=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.