Trial reportESMO open2025
MOVIE phase II trial of tremelimumab plus durvalumab combined with metronomic oral vinorelbine in patients with head and neck cancer.
Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of immunotherapy in head and neck tumors: a systematic review and meta-analysis of clinical outcomes and survival benefits.Frontiers in oncology · 2026Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment options for advanced solid tumors are limited. In recent years, anti-programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) immunotherapy as monotherapy has shown significant efficacy, albeit in a limited subset of patients. In the MOVIE trial, metronomic chemotherapy was combined with two immune checkpoint inhibitors (ICIs) to improve clinical outcomes in patients with advanced solid tumors. PATIENTS AND
methodsMOVIE was a phase I/II French, multicenter, open-label, nonrandomized study with a Bayesian design that evaluated the antitumor activity and safety of metronomic vinorelbine associated with durvalumab plus tremelimumab. Here, we report on the cohort of patients with head and neck squamous cell carcinoma (HNSCC) from the MOVIE phase II study. Patients were aged ≥18 years with histologically confirmed recurrent or metastatic HNSCC, resistant to conventional therapies, and presented a measurable disease according to RECIST version 1.1. They received oral vinorelbine 40 mg three times a week, and durvalumab 1500 mg plus tremelimumab 75 mg via intravenous infusion on day 1 of 28-day cycles, for a maximum of four cycles of tremelimumab. The primary endpoint was the clinical benefit rate (CBR), defined as the rate of complete response (CR), partial response (PR), or stable disease (SD) lasting at least 24 weeks.
resultsFifteen HNSCC patients were included between May 2019 and October 2020. The mean estimated CBR according to a noninformative prior distribution was 23.5% (95% credible interval 7.3-45.6). One patient achieved CR, 1 PR, and 1 SD > 24 weeks, leading to an objective response rate of 14.3%. The median progression-free survival was 1.8 months (95% confidence interval 1.0-1.9 months), and the median overall survival was 8 months (95% confidence interval 2.5-12.7 months). The most common vinorelbine-related grade ≥3 adverse events were anemia (n = 2, 13%) and neutropenia (n = 3, 20%). The most common ICI-related grade ≥3 adverse events were anemia (n = 1) and hypokalemia (n = 1). There were no treatment interruptions for toxicity and no treatment-related deaths.
conclusionsMetronomic vinorelbine in combination with dual durvalumab plus tremelimumab immunotherapy had only moderate activity in pretreated advanced HNSCC.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.