Abstract 3973
Background
In most SCCHN patients receiving palliative treatment with platinum-based chemotherapy, the tumor eventually progresses and requires further treatment options. PD-1 inhibitor nivolumab was authorized in this setting in 2017 after proving superior to single agent chemotherapy in objective response and overall survival. But there are still patients who progress rapidly with nivolumab monotherapy. In this population, prompt escalation of immunotherapy by adding the CTLA-4 antagonist ipilimumab to nivolumab may be beneficial, as this combined checkpoint blockade has proven superior to nivolumab alone in several tumors. It is not clear, though, if combined immunotherapy is superior to chemotherapy in this setting of SCCHN patients responding poorly to nivolumab alone. The OPTIM trial investigates this question.
Trial design
280 patients with recurrent or metastatic SCCHN progressing after platinum-based chemotherapy or within 6 months after RCT will be recruited at 24 German sites. All patients initially receive nivolumab monotherapy according to current prescribing information (240 mg Q2W). They are closely followed for tumor progression by radiologic assessment every 4-6 weeks, i.e. at increased frequency compared to standard of care. Patients who progress during the first 24 weeks of nivolumab monotherapy are randomized 1:1 between intensified immunotherapy (nivolumab 3 mg/kg Q2W + ipilimumab 1 mg/kg Q6W) and chemotherapy (docetaxel 75 mg/m2 Q3W). 157 patients are planned to be randomized. Patients who do not progress during the first 24 weeks of nivolumab monotherapy continue treatment according to standard of care. After randomization, study treatment continues until disease progress or for up to 12 months. The primary endpoint is overall response rate after randomization, hypothesizing that dual checkpoint blockade improves ORR to 25% compared to 10% with docetaxel. Secondary endpoints are overall survival, progression-free survival, safety, and quality of life. Recruitment started in July 2018 and is ongoing.
Clinical trial identification
2017-003349-14.
Editorial acknowledgement
Legal entity responsible for the study
AIO-Studien-gGmbH, Berlin.
Funding
Bristol-Myers Squibb.
Disclosure
V. Grünwald: Full / Part-time employment: University Hospital Essen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony: Cerulean; Advisory / Consultancy, Speaker Bureau / Expert testimony: COCS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: EUSAPharm; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): EISAI; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ipsen; Advisory / Consultancy, Speaker Bureau / Expert testimony: MedUpdate; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck Serono; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: MedKomAkademie; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: NewConceptOncology; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Johnson & Johnson; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: PharmaMar; Advisory / Consultancy, Speaker Bureau / Expert testimony: PeerVoice; Advisory / Consultancy, Speaker Bureau / Expert testimony: StreamedUp!; Advisory / Consultancy, Speaker Bureau / Expert testimony: ThinkWired!. All other authors have declared no conflicts of interest.
Resources from the same session
5218 - Elevated driver mutational burden or number of perturbed pathways and poor response to abiraterone or enzalutamide in metastatic castration-resistant prostate cancer
Presenter: Bram De Laere
Session: Poster Display session 3
Resources:
Abstract
2452 - High proportion of multiple KRAS mutations in circulating tumor DNA and tumor tissue of pancreatic ductal adenocarcinoma
Presenter: Min Kyeong Kim
Session: Poster Display session 3
Resources:
Abstract
3328 - Biological difference of tumor mutational burden (TMB) and microsatellite instability (MSI) status in patients (pts) with somatic vs. germline BRCA1/2-mutated advanced gastrointestinal (GI) cancers using cell-free DNA (cfDNA) sequencing analysis in the GOZILA study
Presenter: Yasuyuki Kawamoto
Session: Poster Display session 3
Resources:
Abstract
3022 - Cell-Free DNA to Detect Focal Versus Non-Focal MET Amplification in Metastatic Colorectal Cancer Patients: Combined Analysis from Japan and the United States
Presenter: Mishima Saori
Session: Poster Display session 3
Resources:
Abstract
2833 - Presence of circulating tumor DNA in surgically resected renal cell carcinoma is associated with advanced disease and poor patient prognosis
Presenter: Andres Correa
Session: Poster Display session 3
Resources:
Abstract
1376 - Combined genomic and epigenomic assessment of cell-free circulating tumor DNA (cfDNA) for cancer diagnosis and recurrence-risk assessment in early-stage lung cancer
Presenter: Junghee Lee
Session: Poster Display session 3
Resources:
Abstract
4050 - DEMo: a prospective evaluation of a prognostic clinico-molecular composite score in NSCLC patients treated with immunotherapy.
Presenter: Arsela Prelaj
Session: Poster Display session 3
Resources:
Abstract
4727 - Bespoke circulating tumor DNA (ctDNA) analysis as a predictive biomarker in solid tumor patients (pts) treated with single agent pembrolizumab (P)
Presenter: Cindy Yang
Session: Poster Display session 3
Resources:
Abstract
3662 - Dynamic changes in whole-genome cell-free DNA (cfDNA) to identify disease progression prior to imaging in advanced solid tumors
Presenter: Andrew Davis
Session: Poster Display session 3
Resources:
Abstract
3817 - Evaluation of Microsatellite Instability Testing Through cell-free DNA sequencing
Presenter: Shile Zhang
Session: Poster Display session 3
Resources:
Abstract