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NCT03518606: MOVIE
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours
Phase 1, PHASE2 trial testing Durvalumab + Tremelimumab + metronomic Vinorelbine in Advanced Solid Tumours in 126 participants. Completed in 19 December 2024.
1 April 2022
Quick facts
| Lead sponsor | UNICANCER |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 126 |
| Start date | 20 June 2018 |
| Primary completion | 1 April 2022 |
| Estimated completion | 19 December 2024 |
| Sites | 9 locations across France |
Drugs / interventions tested
- Durvalumab + Tremelimumab + metronomic Vinorelbine — full drug profile →
Conditions studied
- Advanced Solid Tumours — all drugs for Advanced Solid Tumours →
- Breast Cancer — all drugs for Breast Cancer →
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
- Cervix Cancer — all drugs for Cervix Cancer →
Sponsor
UNICANCER — full company profile →
Who can join
18 and older, any sex, with Advanced Solid Tumours or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of tumor mutation burden as an immunotherapy biomarker: utility for the oncology clinic.
Chan TA, Yarchoan M, Jaffee E, Swanton C, et al · · 2019 · cited 2009× · PMID 30395155 · DOI 10.1093/annonc/mdy495 -
Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038 -
Cervical Cancer Immunotherapy: Facts and Hopes.
Ferrall L, Lin KY, Roden RBS, Hung CF, et al · · 2021 · cited 255× · PMID 33888488 · DOI 10.1158/1078-0432.ccr-20-2833 -
How to turn up the heat on the cold immune microenvironment of metastatic prostate cancer.
Stultz J, Fong L. · · 2021 · cited 173× · PMID 33820953 · DOI 10.1038/s41391-021-00340-5 -
PD-1/PD-L1 Targeting in Breast Cancer: The First Clinical Evidences Are Emerging. A Literature Review.
Planes-Laine G, Rochigneux P, Bertucci F, Chrétien AS, et al · · 2019 · cited 162× · PMID 31336685 · DOI 10.3390/cancers11071033 -
PD-1/PD-L1 Inhibitors in Cervical Cancer.
Liu Y, Wu L, Tong R, Yang F, et al · · 2019 · cited 113× · PMID 30774597 · DOI 10.3389/fphar.2019.00065 -
Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295 -
Immunotherapy for HER2-positive breast cancer: recent advances and combination therapeutic approaches.
Ayoub NM, Al-Shami KM, Yaghan RJ. · · 2019 · cited 69× · PMID 30697064 · DOI 10.2147/bctt.s175360
Verify or expand the search:
- PubMed search for NCT03518606
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumours
Currently open trials in the same condition.
- NCT06868199 — A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
- NCT06795412 — Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06815575 — A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours. · Phase 1 · recruiting
- NCT05701527 — A Study of EBC-129 in Advanced Solid Tumours · Phase 1 · recruiting
- NCT06927349 — A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors. · Phase 1 · recruiting
Other UNICANCER trials
Trials by the same sponsor.
- NCT07340619 — Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With · Phase 2 · not yet recruiting
- NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting
- NCT07360834 — Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndr · NA · not yet recruiting
- NCT07106632 — Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests · Phase 3 · not yet recruiting
- NCT07294430 — Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03518606 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNICANCER
- Last refreshed: 15 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03518606.
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