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
3489 - Overall Survival (OS) and Metastasis-Free Survival (MFS) in men with Biochemically Relapsed (BCR) Prostate Cancer after radical prostatectomy (RP) managed with deferred Androgen Deprivation Treatment (ADT): A combined Johns Hopkins and CPDR study
Presenter: Catherine Marshall
Session: Poster Display session 3
Resources:
Abstract
4606 - ARCHES – the role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups
Presenter: Arnulf Stenzl
Session: Poster Display session 3
Resources:
Abstract
2975 - Updated survival analyses of a multicentric phase II randomized trial of docetaxel (D) plus enzalutamide (E) versus docetaxel (D) as first line chemotherapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (CHEIRON study).
Presenter: Orazio Caffo
Session: Poster Display session 3
Resources:
Abstract
2708 - Real-world analysis of patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) receiving vs not receiving chemotherapy in the treatment sequence
Presenter: Alicia Morgans
Session: Poster Display session 3
Resources:
Abstract
2134 - Baseline fracture risk in men with prostate cancer starting the STAMPEDE trial
Presenter: Janet Brown
Session: Poster Display session 3
Resources:
Abstract
3504 - Risk of falls and fractures in patients with castration resistant prostate cancer (CRPC) treated with new hormonal agents – a meta-analysis of randomized controlled trials.
Presenter: Rodrigo Coutinho Mariano
Session: Poster Display session 3
Resources:
Abstract
2342 - Pain progression at initiation of chemotherapy in metastatic Castration-Resistant Prostate Cancer (mCRPC) is associated with a poor prognosis: a post-hoc analysis of FIRSTANA
Presenter: Nicolas Delanoy
Session: Poster Display session 3
Resources:
Abstract
5331 - Pain evaluation in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the PARABO observation study
Presenter: Holger Palmedo
Session: Poster Display session 3
Resources:
Abstract
2823 - Time to castration resistant prostate cancer (CRPC) and the risk of developing immune disorders
Presenter: Vincenza Conteduca
Session: Poster Display session 3
Resources:
Abstract
1500 - Retrospective evaluation of neutropenic admission events in metastatic or high-risk hormone-sensitive prostate cancer (HSPC) patients having docetaxel chemotherapy upfront or for castrate-resistant prostate cancer (CRPC) in STAMPEDE
Presenter: Harriet Mintz
Session: Poster Display session 3
Resources:
Abstract